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D2.2 Risk Analysis
D2.2 Risk Analysis
REVISION HISTORY
Version Date Nature of modifications Writer
A 20012020 Creation Zo RAOLISON
Table of contents
1 Purpose............................................................................................................................................ 2
2 List of documents ............................................................................................................................ 2
3 TF-510 RISK MANAGEMENT PLAN................................................................................................... 3
3.1 PURPOSE ................................................................................................................................... 4
3.2 INTRODUCTION ......................................................................................................................... 4
3.3 SCOPE OF THE RISK MANAGEMENT PLAN ................................................................................ 4
3.4 RESPONSIBILITIES AND AUTHORITIES ....................................................................................... 4
3.5 PRODUCT DEFINITION............................................................................................................... 5
3.5.1 Medical device description ................................................................................................ 5
3.5.2 Intended use ...................................................................................................................... 6
3.5.3 Indications for use ............................................................................................................. 7
3.5.4 Expected performance ...................................................................................................... 7
3.5.5 Preliminary hazard analysis ............................................................................................... 7
3.5.6 Medical device life cycle steps......................................................................................... 13
3.6 RISK ANALYSIS ......................................................................................................................... 14
3.6.1 Method used to analyze risk ........................................................................................... 14
3.6.2 Risk control options ......................................................................................................... 14
3.6.3 Risk quotation criteria ..................................................................................................... 14
3.6.4 The severity scale ............................................................................................................ 15
3.6.5 The probability of occurrence scale ................................................................................ 15
3.6.6 Risk acceptability Criteria ................................................................................................ 16
3.6.7 Risk-benefit evaluation criteria ....................................................................................... 17
3.7 Verification and evaluation of overall residual risk ................................................................ 17
3.7.1 Review of all residual risks ............................................................................................... 17
3.7.2 Method used to analyze overall residual risk .................................................................. 18
3.7.3 Review for conflicting requirements ............................................................................... 18
3.7.4 Review of warnings in the manuals/ instructions for use ............................................... 18
3.7.5 Residual risk interactions ................................................................................................. 18
3.7.6 Global residual risk .......................................................................................................... 18
Proprietary and confidential. Not to be redistributed without prior permission of Multiwave Innovation.
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3.7.7 Overall residual risk acceptability criteria ....................................................................... 19

3.8 Risk Management report & updates ...................................................................................... 20
3.8.1 Frequency of reviews/reports ......................................................................................... 20
3.8.2 Contents of the review / risk management report ......................................................... 20
3.9 Method of collecting production and post production information ...................................... 20
4 RISK ANALYSIS MATRIX .................................................................................................................. 20
5 TF-530 RISK MANAGEMENT REPORT ............................................................................................ 21
5.1 Purpose ................................................................................................................................... 22
5.2 Scope of the risk assessment .................................................................................................. 22
5.3 Participants ............................................................................................................................. 22
5.4 Risk management plan............................................................................................................ 22
5.5 Risk management review ........................................................................................................ 22
5.5.1 Individual residual risks review........................................................................................ 22
5.5.2 Risk analysis ..................................................................................................................... 23
5.5.3 Usability risk analysis ....................................................................................................... 23
5.5.4 Overall risk analysis ......................................................................................................... 24
5.5.5 Review of conflicting requirements................................................................................. 24
5.5.6 Review of warnings and instructions for use................................................................... 24
5.5.7 Residual risk interaction .................................................................................................. 24
5.6 Global residual risk.................................................................................................................. 25
5.6.1 Risk analysis ..................................................................................................................... 25
5.6.2 Usability risk analysis ....................................................................................................... 25
5.7 Overall residual risk acceptability criteria............................................................................... 25
5.8 PRODUCTION AND POST PRODUCTION INFORMATION......................................................... 25
6 CONCLUSION ................................................................................................................................. 26
7 ANNEX : RISK ANALYSIS MATRIX ................................................................................................... 26
1 Purpose
This document is a report on the Risk analysis work carried out on the MRI PADS 7TLF. It is the
deliverable D2.2 of the work package CE documents. It describes the risk management plan for the
device, the completed risk analysis matrix and the risk management report.
2 List of documents
The risk analysis files are organized into several parts:
- Risk management plan (present document) : TF-510 Risk management plan

- Risk analysis following the medical device life cycle: TF-520 Risk Analysis Matrix
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D2.2 Risk Analysis
- Risk management report: TF-530 Risk management report

These documents form an integral part of the Technical File of the medical device MRI pads 7TLF. The
purpose of the risk management plan is to provide a description of the risk management file and the
method used to identify and reduce risks of this device throughout its life-cycle. It defines the scope,
responsibilities, requirements and review of risks according to the EN ISO 14971: 2012. The risk analysis
presents the results on the risk analysis of the device, the list of required proofs to ensure its safety
and performance and the processes set up to ensure its safety.
The risk management report completes the risk management process undertaken by MULTIWAVE on
the MRI Pads 7TLF throughout the total product life cycle.
A usability engineering file is performed in parallel with the design dossier and the usability risks are
included in the risk management file. More information on usability can be found in the deliverable
D2.3.
Only the files TF-510, TF-520 and TF-530 are provided in this current document. In each file, additional
documents are cited and can be provided upon request.
3 TF-510 RISK MANAGEMENT PLAN
MRI PADS
RISK MANAGEMENT PLAN
EDITION
Function Name Position
Writer Zo RAOLISON Material Science Engineer
Tryfon
Approver Director of Multiwave Imaging
ANTONAKAKIS
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3.1 PURPOSE
The purpose of this risk management plan is to provide a description of the risk management file and
the method used to identify and reduce risks related to the MRI Pads product family throughout the
products life-cycle. It defines the scope, responsibilities, requirements and review of risks according to
the EN ISO 14971:2012 standard.
3.2 INTRODUCTION
The risk management process is conducted according to the principles outlined in EN ISO 14971:2012.
The risk management file is organized into several parts:
- Risk management plan

- Risk analysis following the medical device life cycle
- Risk management report
The following elements provide important and necessary inputs to the risk management file:
- Usability Engineering file

- Clinical Evaluation Report
- Post-Market Surveillance Report
3.3 SCOPE OF THE RISK MANAGEMENT PLAN

The risk management plan describes:
- The characteristics of the medical device

- The responsibilities and authorities regarding the construction of the risk management file
- The procedures for updating the risk management file
- Methods for performing risk analyses (following the medical device life cycle)
- Method for controlling the risks
- The criteria used to estimate the risks
- The risk acceptability criteria (initial risks before risk control, after risk control and overall
residual risks)
- Criteria for evaluation of the risk-benefit ratio
- Verification activities
- Methods for performing overall residual risk analysis
- The elements which must appear in the risk management report as well as the frequency of
review of the risk management file
- The methods and actions used to collect the post-production and post market information
- A reminder of input elements: post market information, clinical evaluation, standards and
regulations, etc.
When subcontractors have already competed a risk analysis pertaining to their manufacturing
activities, it becomes part of our risk analysis after evaluation and approval.
3.4 RESPONSIBILITIES AND AUTHORITIES

Persons performing risk management tasks shall have:
- knowledge of and experience with the medical device (or similar medical devices), its use and the
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D2.2 Risk Analysis
technologies involved;
- knowledge of and experience with risk management techniques;
- knowledge of the state of the art concerning the use of the medical device.
NOTE Risk management tasks can be performed by representatives of several functions, each
contributing their specialist knowledge.
Name Company Function Responsibilities Authorities Competencies
Multiwave Expert, writer and

Luisa NEVES Engineer 1-2-3
Imaging reviewer
Multiwave Expert, writer and

Zo RAOLISON Engineer 1-2-3
Imaging reviewer
Kaizad Multiwave Expert and

Engineer 1-3
RUSTOMJI Imaging reviewer
Head of
Multiwave
Elodie Multiwave Expert and
Imaging and 1-2-3
GEORGET-PARIS Imaging reviewer
Medical
Technologies
Director of Accountable for

Tryfon Multiwave Approval
Multiwave risk management 1-2-3
ANTONAKAKIS Imaging authority
Imaging process
3.5 PRODUCT DEFINITION

3.5.1 Medical device description
The MRI Pad is an accessory used to enhance the local field in 7T MRI scanners by improving its
homogeneity. The MRI Pad consists of a composite material hermetically sealed into a flexible plastic
pouch (Cf. Figure 1). They are generally used by two, positioned oppositely on each side of the area of
interest of the human body.
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Figure 1. Two PADS 7TNS
During an MRI scan, the patient is in supine position on a bed which is introduced in the scanner.
The PADS 7TNS, PADS 7TSC and PADS 7TLF are lateral pads to be used with 7T MRI scanners. They are
positioned on each side of the patient head close to the temporal lobes (Cf. Figure 2).
The pads may come into contact with the skin, or the hair of the patient for brain imaging pads, and
must remain in position throughout the MRI scan.
Figure 2. Patient in supine position with two lateral 7T Pads on each side of the head.
3.5.2 Intended use

The PADS 7TNS are used to improve local magnetic B1+ field homogeneity in 7T MRI scanners for
imaging the temporal lobes of the brain in an adult population.
The PADS 7TSC are used to improve local magnetic B1+ field homogeneity in 7T MRI scanners for
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The PADS 7TLF are used to improve local magnetic B1+ field homogeneity in 7T MRI scanners for
3.5.3 Indications for use

The MRI Pads are used as an imaging accessory for improving MR images of the brain in an adult
population. They are designed for use inside an MRI birdcage coil for MRI imaging at high and ultra-
high field, in a hospital environment. The images, when interpreted by a trained physician, yield
information that may assist in diagnosis.
3.5.4 Expected performance

The use of Pads on the brain, allows to obtain locally enhanced transmitted magnetic field !"# field
map, and thus better-quality diagnostic images of anatomical areas of interest.
3.5.5 Preliminary hazard analysis

To perform the preliminary hazard analysis, the characteristics of the medical device that may affect
safety were identified by the risk project team and listed in the table below (EN ISO 14971:2012 annex
C).
N° Question wording Answer
C.2.1 What is the intended use and how is the medical device to
be used?
what is the medical device's role relative to: The medical device is an MRI accessory used
- diagnosis, prevention, monitoring, treatment or alleviation for MRI body imaging in a generic MRI
of disease, scanner at 7 Tesla. It can be used to image
- compensation for injury or handicap or adults of both genders.
- Replacement or modification of anatomy, or control of
conception?
What are the indications for use (e.g. patient population)?
Does the medical device sustain or support life?
-is special intervention necessary in the case of failure of the
medical device?
C.2.2 Is the medical device intended to be implanted? No.

C.2.3 Is the medical device intended to be in contact with the Yes.
patient or other persons?
Factors that should be considered include the nature of the The Pads may come into contact with the
intended contact, i.e. surface contact, invasive skin of the patient, or the hair for brain
contact, or implantation and, for each, the period and imaging pads.
frequency of contact Operators hands are in contact with the Pads
during its installation or storage.
C.2.4 What materials or components are utilized in the medical
device or are used with, or are in contact with the medical
device?
Factors that should be considered include: The external part of the Pad is made of a
- Compatibility with relevant substances; plastic pouch that is commonly used in the
- Compatibility with tissues or body fluids; food industry.
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- Whether characteristics relevant to safety are known;

- Is the device manufactured utilizing materials of animal
origin?
C.2.5 Is energy delivered to or extracted from the patient? Yes.
Factors that should be considered include: Non-ionizing radiation is delivered to the
- The type of energy transferred; patient.
- Its control, quality, quantity, intensity and duration; However, the pad only redistributes the
- Whether energy levels are higher than those currently used energy delivered by the MRI Scanner, which
for similar devices. is in control of the global SAR.
The possible hazardous situation is the
delivery of a higher local SAR.
C.2.6 Are substances delivered to or extracted from the patient? No.

Factors that should be considered include
- Whether the substance is delivered or extracted;
- Whether it is a single substance or range of substances;
- The maximum and minimum transfer rates and control
thereof
C.2.7 Are biological materials processed by the medical device for No.
subsequent re-use, transfusion or transplantation? Are
biological materials processed by the medical device for
subsequent re-use, transfusion or transplantation?
Factors that should be considered include the type of
process and substance(s) processed (e.g. autotransfusion,
dialysis, blood component or cell therapy processing).
C.2.8 Is the medical device supplied sterile or intended to be No.
sterilized by the user, or are other microbiological controls
applicable?
Factors that should be considered include
- Whether the medical device is intended for single use or re-
use packaging;
- Shelf-life issues;
- Limitation on the number of re-use cycles;
- Method of product sterilization;
- The impact of other sterilization methods not intended by
the manufacturer.
Is the medical device intended to be routinely cleaned and Yes.
disinfected by the user?
Factors that should be considered include the types of The Pads must be cleaned after each use.
cleaning or disinfecting agents to be used and any
limitations on the number of cleaning cycles. The design of
C.2.9
the medical device can influence the effectiveness
of routine cleaning and disinfection. In addition,
consideration should be given to the effect of cleaning and
disinfecting agents on the safety or performance of the
device.
C.2.10 Is the medical device intended to modify the patient Yes.
environment?
Factors that should be considered include: The Pads will locally increase the
Temperature, humidity atmospheric gas composition temperature by a few degrees and generate
pressure, light.
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skin humidity. It will also generate a slight

pressure on the torso or lobes.
C.2.11 Are measurements taken? No.
Factors that should be considered include the variables
measured and the accuracy and the precision of the
measurement results.
C.2.12 Is the medical device interpretative? No.
Factors that should be considered include whether
conclusions are presented by the medical device from input
or acquired data, the algorithms used, and confidence limits.
Special attention should be given to unintended applications
of the data or algorithm.
C.2.13 Is the medical device intended for use in conjunction with Yes.
other medical devices, medicines or other medical
technologies?
Factors that should be considered include identifying any The Pads will be used with a 7T MRI scanner
other medical devices, medicines or other medical with a birdcage coil and other accessories
technologies that can be involved and the potential such as comfort cushions.
problems associated with such interactions, as well as
patient compliance with the therapy.
C.2.14 Are there unwanted outputs of energy or substances? Yes.
Energy-related factors that should be considered include Some unwanted outputs can be generated,
noise and vibration, heat, radiation (including ionizing, non- such as temperature increase
ionizing, and ultraviolet/visible/infrared radiation), contact (patient/environmental).
temperatures, leakage currents, and electric or magnetic
fields.
Substance-related factors that should be considered include
substances used in manufacturing, cleaning or testing having
unwanted physiological effects if they remain in the product.
Other substance-related factors that should be considered
include discharge of chemicals, waste products, and body
fluids.
C.2.15 Is the medical device susceptible to environmental Yes.
influences?
Factors that should be considered include The Pads are susceptible to pressure
- the operational, transport and storage environments. fluctuations and shocks or impacts.
- light, temperature, humidity, vibrations, spillage,
susceptibility to variations in power and cooling supplies,
- Electromagnetic interference.
C.2.16 Does the medical device influence the environment? Yes.
Factors that should be considered include: The Pads can modify the B1+ field in the
- the effects on power and cooling supplies; vicinity of the Pad.
- emission of toxic materials;
- the generation of electromagnetic disturbance.
C.2.17 Are there essential consumables or accessories associated No.
with the medical device?
Factors that should be considered include specifications for
such consumables or accessories and any restrictions placed
upon users in their selection of these.
C.2.18 Is maintenance or calibration necessary? No.
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Factors that should be considered include:

- whether maintenance or calibration are to be carried out
by the operator or user or by a specialist;
- are special substances or equipment necessary for proper
maintenance or calibration?
C.2.19 Does the medical device contain software? No.
Factors that should be considered include whether software
is intended to be installed, verified, modified or exchanged
by the operator or user or by a specialist.
C.2.20 Does the medical device have a restricted shelf-life? Yes.
Factors that should be considered include labelling or Limited lifetime of 13 months after
indicators and the disposal of such medical devices when the manufacturing / 12 months after supply
expiration date is reached. (independently of use).
Hazardous chemical: disposal according to
instructions-for-use (return to
manufacturer).
C.2.21 Are there any delayed or long-term use effects? Yes.
Factors that should be considered include: Repeated handling could damage the outer
-ergonomic and cumulative effects. shell, everyday use of cleaning agent would
Examples could include pumps for saline that corrode over induce ageing process on outer shell.
time, mechanical fatigue, loosening of straps and
attachments, vibration effects, labels that wear or fall off,
long term material degradation
C.2.22 To what mechanical forces will the medical device be
subjected?
Factors that should be considered include whether the The Pads will be subjected to the patients’
forces to which the medical device will be subjected are weight/pressure.
under the control of the user or controlled by interaction
with other persons
C.2.23 What determines the lifetime of the medical device?
Factors that should be considered include ageing and battery The homogeneity of the composite material
depletion. and the ageing of polymeric exterior.
C.2.24 Is the medical device intended for single use? No.
- does the medical device self-destruct after use?
- Is it obvious that the device has been used?
C.2.25 Is safe decommissioning or disposal of the medical device No.
necessary?
- The waste products that are generated during the disposal
of the medical device itself.
- Does it contain toxic or hazardous material, or is the
material recyclable?
C.2.26 Does installation or use of the medical device require Yes.
special training or special skills?
Factors that should be considered include the novelty of the It can be used by professionals (physician,
medical device and the likely skill and training of the person technician and doctors) with a training in
installing the device. MRI imaging
C.2.27 How will information for safe use be provided?
Factors that should be considered include: Instructions-For-Use (IFU), initial training,
- whether information will be provided directly to the end after sales service planning.
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D2.2 Risk Analysis
user by the manufacturer or will it involve the participation

of third parties such as installers, care providers, health care
professionals or pharmacists and whether this will have
implications for training;
- commissioning and handing over to the end user and
whether it is likely/possible that installation can be carried
out by people without the necessary skills;
- based on the expected life of the device, whether re-
training or re-certification of operators or service personnel
would be required.
C.2.28 Will new manufacturing processes need to be established No.
or introduced?
Factors that should be considered include new technology or
a new scale of production.
C.2.29 Is successful application of the medical device critically Yes.
dependent on human factors such as the user interface? Dependent of patient positioning, IFU
comprehension.
C.2.29.1 Can the user interface design features contribute to use Yes.
error?
Factors that should be considered are user interface design The Pad may not be homogenized before
features that can contribute to use error. Examples of use, the expiration date may be unreadable,
interface design features include: control and indicators, it may be incorrectly positioned.
symbols used, ergonomic features, physical design and
layout, hierarchy of operation, menus for software driven
devices, visibility of warnings, audibility of alarms,
standardization of color coding.
C.2.29.2 Is the medical device used in an environment where No.
distractions can cause use error?
Factors that should be considered include: Used in a hospital environment by a trained
- the consequence of use error; specialist.
- whether the distractions are common place;
- whether the user can be disturbed by an infrequent
distraction.
C.2.29.3 Does the medical device have connecting parts or No.
accessories?
Factors that should be considered include the possibility of
wrong connections, similarity to other products’
connections, connection force, feedback on connection
integrity, and over- and under-tightening.
C.2.29.4 Does the medical device have a control interface? No.
Factors that should be considered include spacing, coding,
grouping, mapping, modes of feedback, blunders, slips,
control differentiation, visibility, direction of activation or
change, whether the controls are continuous or discrete, and
the reversibility of settings or actions.
C.2.29.5 Does the medical device display information? No.
Factors that should be considered include visibility in various
environments, orientation, the visual capabilities of the user,
populations and perspectives, clarity of the presented
information, units, colour coding, and the accessibility of
critical information.
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C.2.29.6 Is the medical device controlled by a menu? No.

Factors that should be considered include complexity and
number of layers, awareness of state, location of settings,
navigation method, number of steps per action, sequence
clarity and memorization problems, and
importance of control function relative to its accessibility and
the impact of deviating 'from specified operating
procedures.
C.2.29.7 Will the medical device be used by persons with special No.
needs?
Factors that should be considered include the user, their
mental and physical abilities, skill and training, ergonomic
aspects, the use environment, installation requirements, and
the patient's capability to control or influence the use of the
medical device, Special attention should be paid to users
with special needs, such as handicapped persons, the elderly
and children. Their special needs might include assistance by
another person to enable the use of a medical device, Is the
medical device intended to be used by individuals with
various skill levels and cultural backgrounds?
C.2.29.8 Can the user interface be used to initiate user actions? No.
Factors that should be considered include the possibility of
initiating a deliberate action for the user to enter a
controlled operation mode, which enlarges the risks for the
patient and which creates awareness for the user for this
condition.
C.2.30 Does the medical device use an alarm system? No.
Factors that should be considered are the risk of false
alarms, missing alarms, disconnected alarm systems,
unreliable remote alarm systems, and the medical staff's
possibility of understanding how the alarm system works.
C.2.31 In what way(s) might the medical device be deliberately
misused?
Factors that should be considered are incorrect use of -Technician might put the two pads on top of
connectors, disabling safety features or alarms, neglect of each other to further illuminate the brain.
manufacturer's recommended maintenance. -Can be used on another part of the body
(knee, elbow, etc.)
-Pad can be used for longer than its 1-year
warranty (wasted exams if pad does not
work anymore)
-Pads might be handled with pliers/come in
contact with piercing objects/be cleaned
with corrosive detergents => Pad can burst
-Technician may fail to follow the safety
instructions when a pad bursts
(patient/technician might swallow or inhale
composite material)
-Technician may dispose of the Pads
him/herself (environmental danger, danger
to staff)
C.2.32 Does the medical device hold data critical to patient care? No.
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Factors that should be considered include the consequence

of the data being modified or corrupted.
C.2.33 Is the medical device intended to be mobile or portable? Yes.
Factors that should be considered are the necessary grips,
handles, wheels, brakes, mechanical stability and durability.
C.2.34 Does the use of the medical device depend on essential No.
performance?
Factors that should be considered are, for example, the The pads are intended to enhance MRI
characteristics of the output of life-supporting devices or the images quality. If the pads do not work as
operation of an alarm. intended, the resulting image would have
artifacts that are very easy to detect by
trained health professionals.
3.5.6 Medical device life cycle steps

Each step of the medical device life cycle is taken into account in the risk management process:
Step Main activities Participants

Selection of composite
electromagnetic properties
Selection of particles
Selection of solvent
Selection of composite weight
Conception ratio Multiwave Imaging
Selection of pouch material
Selection of label material
Sealing process
Selection of packaging
IFU/labeling text
Supply-chain Selection of suppliers
(raw materials or Quality control upon receipt Multiwave Imaging, suppliers
intermediate products) Storage
Preparation of working
environment
Pouch preparation
Composite insertion into the
pouch
Leveling process
Production Multiwave Imaging
Vacuum process
Sealing process
Cleaning process
Labeling process
Quality control before release
Conditioning process
Supply-chain Storage Multiwave Imaging,
(finished products) Transportation to customers transportation company
MRI scan
Clinical use Storage End-users
Cleaning
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Step Main activities Participants

Product Returns (end-of-life
Disposal/recycling Multiwave Imaging, end-users
or defective devices)
3.6 RISK ANALYSIS

3.6.1 Method used to analyze risk
The risk analysis method is based on 4 steps:
1. Identification of safety features, hazards associated with the device, hazardous situations, or
possible harm to the patient or users or environment (§4.3). The list of hazards provided in
annex E of the standard may be used for hazard identification.
2. Evaluation of the probability of occurrence of each hazardous situation, and the severity of the
resulting harm (§4.4 and 4.5)
3. Description of the control options (by design, protective measures, information for safety)
(§6.2 and 6.3)
4. Residual risk evaluation and risk/benefit analysis (§6.4, 6.5 and 6.6)
The 4 steps are documented in an Excel file TF-520 Risk analysis matrix, allowing the risk project team
to follow the entire risk assessment process.
Note: one hazardous situation may cause more than one type of harm. The most serious harm is always
considered when performing risk evaluation.
3.6.2 Risk control options

There are three risk control options used to reduce risk (listed in order of priority):
1. Inherent safety by design;

2. Protective measures in the medical device itself or in the manufacturing process;
3. Information for safety.
Evidence must be provided to demonstrate the efficacy of risk control options.
According to the EU Directive 93/42/EEC, control measures are put in place in order to reduce the risks
as far as possible (i.e. the AFAP method: As Far As Possible).
According to the EU Directive 93/42/EEC and Annex ZA 7.c) of the EN ISO 14971:2012 standard, the
information given to users does not solely allow for additional risk reduction.
If needed, an action plan may be written regarding the application of risk control methods.
3.6.3 Risk quotation criteria

Risk is defined as the combination of the severity of possible harms to the patient or user and the
probability of occurrence of each harm.
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3.6.4 The severity scale

Severity is the measure of the possible consequences (damage, harm or adverse health effect) of a
hazard. Here, a ranking scale from 1 to 4 is used to rank the severity of a potential harm.
Severity level Description Possible harm to user/patient

• Discomfort
Reversible alteration without medical
1: Negligible • Dissatisfaction, loss of time
care
• Infinitesimal local warmth
Reversible light alteration requiring • Minor skin injury

2: Moderate
medical care • Minor local skin irritation
• Major skin/bone injury
• Allergic skin reaction
• Respiratory tract irritation
• Other limited health risks due to
inhalation/ingestion of harmful
3: Significant Reversible severe alteration
chemical component
• Viral or bacterial infection
• Wrong diagnostic leading to
inadequate treatment or unnecessary
additional tests
3.6.5 The probability of occurrence scale

The likelihood ranking, also a scale from 1 to 4, indicates the probability of occurrence of a harm.
Probability level Qualitative likelihood Quantitative likelihood

An event that is very unlikely to < 1 in 1000 devices
1: Improbable
happen < 0.1%
Unlikely to occur during total
Between 1 in 1000 and less than 1 in 100
operational life but may rarely
2: Rare devices
occur when considering all
0.1% - 1%
devices
Between 1 in 100 and less than 1 in 10
May occasionally occur when
3: Probable devices
considering all devices
1% - 10%
Likely to occur at least once
≥ 1 in 10 devices
4: Frequent during operational life of the
≥ 10%
device
Even if the MRI Pad is a reusable medical device, the probability of harm is inferred from the number
of devices put on the market and not from the total number of uses. Indeed, most risks will occur only
once, making the MRI Pad useless and requiring its return to the manufacturer.
In fact, the probability of occurrence of harm is computed as the product of two different probabilities:
- The probability of a hazardous situation occurring (P1)

- The probability of hazardous situation leading to harm (P2)
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P1 and P2 are estimated separately and the overall probability of occurrence P1xP2 is then determined
following the table below.
P2
P1 x P2 Low Moderate High
0-1% 1-10% 10-100%
Low
1: Improbable 1: Improbable 2: Rare
0-1%
Moderate
P1 1: Improbable 2: Rare 3: Probable
1-10%
High
2: Rare 3: Probable 4: Frequent
10-100%
Since we have no historical, production or PMS data, probabilities are initially estimated based on
expert knowledge and common sense, always considering a worst-case scenario (highest possible
probability of occurrence). Experimental data, analytical techniques or simulation may be used in this
assessment.
Probabilities will be re-evaluated using historical, production and PMS data.
3.6.6 Risk acceptability Criteria

The acceptability criteria are defined using the matrix below.
According to the EU Directive 93/42/EEC, all risks should be considered and reduced as far as
possible (even if the risk is in a broadly acceptable region).
The matrix is used to evaluate risks before and after risk control measures are implemented.
Severity
Probability 1: Negligible 2: Moderate 3: Significant
1: Improbable 1 5 7
2: Rare 2 6 10
3: Probable 3 8 11
4: Frequent 4 9 12
Negligible risk (1-7)
Acceptable risk (8-11)
Unacceptable risk (12)
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D2.2 Risk Analysis
3.6.7 Risk-benefit evaluation criteria

According to EN ISO 14971:2012, a risk-benefit analysis is not required for every risk. However, as
stated in point 4 of Annex ZA of the EU Directive 93/42/EEC, it is required that the manufacturer
performs a risk-benefit analysis for the individual risk and the overall risk-benefit analysis in all cases.
The risk-benefit ratio is evaluated by the risk management team who establish the acceptability of the
risk as a function of the expected performance of the device and the actual experience. The benefits
determined in the clinical evaluation report are used as the basis of the evaluation.
Medical Device Benefits are:
- Performance 1: homogenization and enhancement of the transmit B1+ field in the temporal
lobes in the vicinity of the pads.
A risk-benefit analysis is used to justify a risk once all practicable measures to reduce the risk have
been applied. If, after applying these measures, the risk is still below acceptability level, a risk/benefit
analysis is needed to establish whether the medical device is likely to provide more benefit than harm.
Generally, if all practicable risk control measures are insufficient to satisfy the risk acceptability criteria
in the risk management plan, the design or the manufacturing steps shall be modified.
3.7 Verification and evaluation of overall residual risk

The overall residual risk evaluation process occurs subsequent to implementation and verification of
individual risk reduction measures. During the design and development cycle, the risk management
process is focused on individual risks and associated risk reduction measures. During the overall
residual risk evaluation process, the device must be evaluated as a “whole” with all individual risk
reduction measures implemented and tested.
At least once per year, a risk management review is performed; it reviews the risk management plan,
the risk analyses, and all clinically obtained data.
A team is put together to perform the risk review. Note that it is possible to have an external person
on the team.
At the end of the review, a new risk management report is written and archived.
3.7.1 Review of all residual risks

During the risk management review, all risk analyses and risk control measures (reports, technical
documents, instructions for use, etc.) are reviewed. A column is filled in on the day of the review for
the group to ensure that the evidence for each risk control measure is available.
If there is a lack of evidence, an action plan shall be established and a provisional deadline to obtain
the required evidence will be indicated in the corresponding risk analysis Excel file. A summary, in the
form of two risk acceptability tables, is then made based upon the risk analysis files. These two tables
provide an overview of risk reduction through risk control methods. The types of risks are described
and it is ensured that these risks are considered in the clinical evaluation. These tables are part of the
risk management report.
It should be noted that a decrease in the risk score is only effective if the associated evidence is
available; in the absence of this evidence, the initial risks core applies.
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D2.2 Risk Analysis
3.7.2 Method used to analyze overall residual risk

Evaluation of the overall residual risk is the step in which the residual risk is examined from a broad
perspective. In accordance with annex D.7 of EN ISO 14971:2012, the methods below will be used to
evaluate overall residual risk.
3.7.3 Review for conflicting requirements

Risk control measures that are appropriate for individual risks can result in conflicting requirements
when all the risks are evaluated.
During the risk review, special attention should be focused on evaluating any conflicting requirements
between the control options chosen.
If one conflicting requirement is found during the review, the risk controls should be reviewed and a
new risk analysis must be performed until no to eliminate conflicting requirements are found.
3.7.4 Review of warnings in the manuals/ instructions for use

A warning considered on its own may provide adequate risk reduction; however, too many warnings
can reduce the effect of individual warnings.
During the risk analysis review, the team in charge should determine if the warnings are adequate, and
easy to understand, in order to have an acceptable overall residual risk. The team must also ensure
that all risk control measures related to information for safety specified in the risk analysis are included
in the instructions for use.
3.7.5 Residual risk interactions

The overall residual risk must be evaluated in terms of potential combinations of individual residual
risks as well as their frequency and gravity.
A combined risk is a new risk resulting from the simultaneous or concomitant appearance of two or
more dangerous situations.
During the risk management review, the team will separate residual risks that are « combinable » from
those that are « impossible to combine ».
The team must then evaluate if the residual risks can be combined, by asking two main questions:
1. Does a new risk emerge from the combination of the residual risks?
2. Does the combination of the residual risks lead to a higher risk level than each individual residual
risk?
If the answer to one of the two questions is YES, a new risk-benefit analysis of the combined residual
risks must be conducted.
If the answer is NO for both questions, there is no need for a further risk-benefit analysis.
3.7.6 Global residual risk

Considering 16 risk values placed in the table of §6.4.
At the time of the review, the working group will ensure that:
· There is no longer any unacceptable risk (no risk > 11)

· The average risk is acceptable (average risk ≤ 7)
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D2.2 Risk Analysis
Average risk: Ar = ∑ Rn / N with N total number of risks and Rn the individual risk value.
3.7.7 Overall residual risk acceptability criteria

The table below summarizes the acceptability criteria used to assess the overall residual risk.
Acceptability criteria Answers given during the review

Residual risk interaction
New risk identified YES/ NO
Risk with a higher risk level YES / NO
Conflicting requirements YES / NO
Review of warnings
Inadequate warning in instruction
YES / NO
manual
Comparison of risks
New risks or higher-level risks YES / NO
ACCEPTABILITY of OVERALL
UNACCEPTABLE(*)/ ACCEPTABLE
RESIDUAL RISK
(*): the overall residual risk is judged unacceptable if one or more of the
answers in the right column is YES.
If a new risk or a higher risk is identified, new risk control options must be applied in order to reduce
the risk to an acceptable level, and a new risk analysis performed.
If conflicting requirements are found, the team in charge of the review must find a way to reduce them
until the associated risk becomes acceptable
If inadequate warnings are found in the manual, or the instructions are difficult to understand or
incoherent, the team in charge of the review must modify the manual such that no inadequate
warnings remain.
If no solutions can be found to reduce risks to acceptable levels, the design and/or the production
should be modified or stopped.
N.B.: In accordance with Article 7 of the standard EN ISO 14971:2012, in the case where the overall
residual risk is deemed to be unacceptable according to the criteria set out in the Article, the team
must establish whether the medical advantages of the intended usage of the device outweigh the
overall residual risk.
The risk-benefit ratio for the overall residual risk is evaluated with the help of the clinical evaluation.
This risk-benefit ratio is qualitative and is based on the literature about the product itself and similar
products.
If the medical benefit outweighs the overall residual risks, then the latter are deemed to be acceptable.
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D2.2 Risk Analysis
3.8 Risk Management report & updates

3.8.1 Frequency of reviews/reports
At least once a year, a risk management review is carried out. This is a review of the risk management
plan, the risk analyses, the PMS file and the clinical evaluation.
Any corrective and preventative actions implemented are evaluated using the product review (PMS)
to verify that the agreed actions are effective.
Additional risk management reviews may take place as required upon the occurrence of particular
events: customer complaints, adverse events, ANSM website alerts, literature reviews, etc.
A team must be established for this additional review; afterwards, a new risk management report is
written and archived.
3.8.2 Contents of the review / risk management report

Prior to the first placing of the product on the market, and in accordance with the risk management
procedure, a risk management review is performed. After this review, the risk management report
makes it possible to guarantee and ensure:
1. The risk management plan has been appropriately implemented
2. The overall residual risk has been reviewed and is acceptable
3. Appropriate methods are in place to obtain relevant production and post-production information
Once the product is on the market, a review of the risk management file is carried out on a yearly basis
or whether a change occurs that could impact patient safety (field feedback, adverse events, changes
in the design, etc.).
3.9 Method of collecting production and post production information

Procedure is followed to collect production and post-production information.
At a minimum, the collected data must include:
· Product and supplier non-conformities

· Customer complaints
· Customer satisfaction
· Changes in the literature
· Adverse events of similar products
· Production information directly related to the product
These data are part of the post market surveillance and allow regular updating of risk management.
End of the document
4 RISK ANALYSIS MATRIX

The complete risk analysis matrix is provided in annex 1 as a PDF document.
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D2.2 Risk Analysis
5 TF-530 RISK MANAGEMENT REPORT

TF-530 RISK MANAGEMENT REPORT
MRI PADS for 7T
EDITION
Function Name Position
Material science
Writer Zo RAOLISON
engineer
Head of Multiwave
Auditor/ Elodie Innovation and
Approver Georget-Paris Medical
Technologies
Page 21 sur 26
D2.2 Risk Analysis
5.1 Purpose
This document forms an integral part of the Technical File of the medical device MRI pads 7TLF. The
purpose of this document is to present the risk management report of the medical device "MRI PADS
7TLF" according to EN ISO 14971 : 2013.
5.2 Scope of the risk assessment

This document only applies to the medical device MRI Pads for 7TLF.
This summary completes the risk management process undertaken by MULTIWAVE on the MRI Pads
for 7TLF throughout the total product life cycle.
Refer to the risk management plan for full details.
5.3 Participants
The present report also presents the final risk management review.
Name Role and responsibilities

Auditor/
Elodie Georget-Paris
Approver
Raolison Zo Writer
Luisa Neves Writer
5.4 Risk management plan
The risk management plan was followed:
• Responsibilities were defined
• Product identification was accomplished
• Preliminary hazard analysis was performed using Annex C of EN ISO 14971: 2012
• Methods of risk mitigation were defined
1. Identification of safety features, hazards associated with the device, hazardous

situations, or possible harm to the patient or users or environment
2. Evaluation of the probability of occurrence of each hazardous situation, and the

severity of the resulting harm
3. Description of the control options (by design, protective measures, information for
safety)
4. Residual risk evaluation and risk/benefit analysis according to EN ISO 14971:2012
5.5 Risk management review

5.5.1 Individual residual risks review
The team listed above met to perform the risk management review.
During the meeting, a step-by-step method was used to analyze each risk analysis file:
1) Each risk was identified by a number. The risks were then estimated and evaluated according to
the severity scale and frequency scale (defined in section 7.3 of the Risk Management Plan). The team
then determined the acceptability of each risk.
Page 22 sur 26
D2.2 Risk Analysis
2) The risk control options were defined according to the risk management plan (inherent safety by
design, protective measures, information for safety).
3) The team determined whether or not the risk control options could generate new risks.
4) The effectiveness of the risk control options was verified by the team and the associated
documentation (reports, validation files, technical file sections, instructions for use, etc.) was noted.
5) The team evaluated the evidence in order to decide whether the evidences are sufficient to
decrease the risk
6) Then, the “individual” risk was re-evaluated using the same criteria
7) The risk-benefit ratio was determined by the team using the intended performance as part of the
benefits.
The tables below present the risk assessments and levels of acceptability as determined from the risk
analysis file and the usability risk analysis file, thus providing an overview of the effectiveness of risk
reduction through the implementation of risk control methods.
5.5.2 Risk analysis

5.5.3 Usability risk analysis
Severity (S) Severity (S)
Before risk 1 2 3 After risk 1 2 3
control Negligible Moderate Significant control Negligible Moderate Significant
1 1
27 0 3 59 2 33
Rare Rare
Probability (P)
2 2
32 1 14 84 27 27
Occasional Occasional
3 3
14 12 27 16 5 4
Probable Probable
4 4
88 21 20 2 0 0
Frequent Frequent
Example of types of risk encountered:

- Infinitesimal local heating
- Health issues
- Discomfort
- Loss of time
- Allergy
Comparing the two tables above, the group found that, in general, the risks were reduced by reducing
the likelihood of appearance. In order to do so, the following risk management measures have been
implemented:
Inherent safety by design Protective measures Information for safety
Page 23 sur 26
D2.2 Risk Analysis
- Amount of substance inside

the MD - Control at reception of raw
- Information for safety
- MD use by trained medical materials
added to the IFU
professional - Visual inspection in
- Selection of suitable raw production
materials
During the review, the effectiveness of risk reduction measures was verified and was determined to
be appropriate. Each residual risk was deemed acceptable in view of patient benefit.
To the best of our knowledge all use errors and hazards associated have been identified at this time.
5.5.4 Overall risk analysis

The overall risk analysis is done accordingly to the methods presented in the Risk Management Plan
and the annex D.7 of EN ISO 14971. This analysis is conducted on both the product risk analysis and
the usability risk analysis.
5.5.5 Review of conflicting requirements

During the risk review, efforts were taken to avoid conflicting requirements between the control
options chosen.
No conflicting requirements were identified in both analyses.
5.5.6 Review of warnings and instructions for use

All the elements mentioned in the " Information" column of the risk analysis have been verified and
are found in the instructions for use.
The instructions were reviewed by the working group and were considered coherent and easy to follow
for the targeted users.
The formative and summative evaluation, carried out as part of the usability validation according to
the EN 62366-1: 2015, confirmed this statement.
5.5.7 Residual risk interaction

The working group imagined disaster scenarios through discussion and brainstorming by combining
several individual risks from both risk analysis and usability risk analysis.
One of the most disastrous scenarios was the use of pads which are:
- with the wrong properties,
- mixed with the wrong particles leading to an inhomogeneous state
- with a solvent and pouch that is not chemically compatible (inert to each other) and therefore leading
to a leaking pad
- sealing with an uncalibrated not adapted sealer that leads to weak seals and prone to leaking.
It results in an uncomfortable leaking thick pad that are used on the wrong region without the user or
the patient noticing they are leaking. In that case, there are health issues for both the user and the
patient due to the contact/inhalation/ingestion of particles and burns and/or death for the patient due
to the high level of energy radiated to its head.
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D2.2 Risk Analysis
By combining a set of scenarios for the use of a non-compliant device by untrained practitioners, the
group arrived at the same risks as the risks already identified. No new or higher-level risks were
identified by this combination analysis.
Furthermore, the conclusions of the clinical evaluation also do not show any new risks from clinical
use. Based on the clinical evaluation, reflecting all known clinical situations, the benefit-risk ratio for
the overall residual risk remains acceptable.
5.6 Global residual risk
During the review, the global residual risk was investigated according to the Risk Management Plan,
the §5.1 of the present document and the risk acceptability criteria table.
5.6.1 Risk analysis

the working group have ensured that:
· No unacceptable risk left (worst risk = 12)

· The average risk is acceptable (average risk = 4.5)
With average risk: Ar = ∑ Rn / N with N total number of risks and Rn the individual risk value.
5.6.2 Usability risk analysis

the working group have ensured that:
· No unacceptable risk left (worst risk = 11)

· The average risk is acceptable (average risk = 3.5)
With average risk: Ar = ∑ Rn / N with N total number of risks and Rn the individual risk value.
5.7 Overall residual risk acceptability criteria

The table below summarizes the acceptability criteria used to assess the overall residual risk.
Acceptability criteria Answers given during the review
Risk combination
New risk identified? NO
Risk with a higher risk level? NO
Conflicting requirements NO
Review of warnings
Inadequate warning or unclear instructions in the manual? NO
ACCEPTABILITY of OVERALL RESIDUAL RISK ACCEPTABLE
The benefit of using the MRI pads for 7T head scans is an enhancement of the B1+ field in the vicinity
of the pads leading to images that may help for improved diagnosis and treatment. Used with due
caution by the intended user, the benefits of the pads outweigh the risks of its use.
Furthermore, the usability file demonstrates that the MRI pads for 7T Head are easy to use. The patient
benefits outweigh the risks identified.
5.8 PRODUCTION AND POST PRODUCTION INFORMATION

Production and post-production information were collected.:
· Product and supplier non-conformities
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D2.2 Risk Analysis
· Customer complaints
· Customer listening
· Changes in the literature
· Adverse events of similar products
· Production information directly related to the product
6 CONCLUSION
At the date of the risk management review, the state of the risk management file is as follows:
1. The Risk Management Plan is deemed to be appropriate: the responsibilities and the
method used by all members of the risk analysis team are well defined
2. Risk Analysis files: risk control measures are appropriate
3. The Instructions for use were updated
4. Overall Residual Risk was reviewed and deemed acceptable
5. Appropriate Methods have been put in place to collect relevant production and post-
production information
Considering all the data obtained and the expected benefits for the patient, the working group
concluded that the overall residual risk is acceptable and that the benefit / risk ratio is in the patient’s
favor for both product risk analysis and usability risk analysis.
End of the document
7 ANNEX: RISK ANALYSIS MATRIX
Page 26 sur 26
Accept
TECHNICAL FILE
Ref : Risk analysis
Estimation and initial assessment

Final assessm
Identification of safety features, hazards associated with the device, hazardous situations, or possible harm to the patient or users or environment according to the Risk Management Risk control approach of the following measures, according to the Risk Management Plan
the risk mana
Plan
Overall Probability
Overall Probability
Severity
Severity
Step of the medical Device Harm to the user / patient / Initial Information for safety
Activity Risk number Hazard Foreseeable sequence of events Hazardous situations P1 P2 Inherent safety by design Protective measures Efficacy of the risk control measures P1 P2
device Life cycle concerned environment risk (IFU)
Product design validation [1]

The composite material of the pad has
ABC Local warmth (patient) M M 2 1 2 The use of the pads may lead to SAR simulation report [2] L M 1 1
Electromagnetic/ inappropriate dielectric properties: permittivity is Excessive energy is delivered to the
C1.01 Dielectric properties of chosen a slight increase in local SAR (up Stability report [3]
C1 - Selection of thermal energy too high (normal conductivity) or conductivity is too body.
ABC Infinitesimal local warmth (patient) M L 1 1 1 composite material are known to 28%) Material technical specifications [5,6,7,8,10] L L 1 1
composite high (normal permittivity).
C - Conception and appropriate for use Supplier selection procedure [11]
electromagnetic
The composite material of the pad has Receipt files [12,13,14,15]
properties Insufficient energy is delivered to the Dissatisfaction, loss of time
C1.02 Functional ABC inappropriate dielectric properties: permittivity is H H 4 1 4 local temperature increase IFUs [26,27,28] L H 2 1
body. (user/patient)
too low and conductivity is too high. PMS report [29]
ABC Local warmth (patient) M M 2 1 2 Product design validation [1] L M 1 1

Electromagnetic/ Excessive energy is delivered to the
C2.01 SAR simulation report [2]
thermal energy The size of particles (composite raw material) is body. Supplier control
ABC Infinitesimal local warmth (patient) M L 1 1 1 L L 1 1
Stability report [3]
inappropriate. Control of particles/ composite Visual check before use (do not
C2 - Selection of Insufficient energy is delivered to the Dissatisfaction, loss of time Size of particles is appropriate Particles technical specifications [6]
C - Conception C2.02 Functional ABC The pad is inhomogeneous (appearance of "stones" H H 4 1 4 at reception use if filling is stiff or not L H 2 1
particles body. (user/patient) for use Supplier selection procedure [11]
and/or "lumps") or too fluid, with varying QC inspection before releasing homogeneous)
Particles receipt files [13]
permittivity. An unhomogeneous/uneven pad is finished pads
C2.03 Operational ABC Discomfort (patient) H H 4 1 4 IFUs [26,27,28] L H 2 1
positioned next to the patient's head.
PMS report [29]

thermal energy The solvent is not chemically compatible with the body.
particles. Solvent properties are Supplier control Visual check before use (do not
C3 - Selection of Insufficient energy is delivered to the Dissatisfaction, loss of time Solvent technical specifications [8]
C - Conception C3.02 Functional ABC The pad is inhomogeneous (appearance of "stones" H H 4 1 4 appropriate for use with Control of solvent/composite at use if filling is stiff or not L H 2 1
solvent body. (user/patient) Supplier selection procedure [11]
and/or "lumps") or too fluid, with varying specified particles reception homogeneous)
Solvent receipt files [15]
permittivity. An unhomogeneous/stiff/uneven pad is
C3.03 Operational ABC Discomfort (patient) H H 4 1 4 IFUs [26,27,28] L H 2 1
PMS report [29]

thermal energy The proportions of the composite raw materials are body. Supplier control
C4 - Selection of inappropriate. The proportions of the Control of composite material at Visual check before use (do not
Insufficient energy is delivered to the Dissatisfaction, loss of time Composite technical specifications [7]
C - Conception composite weight C4.02 Functional ABC The pad is inhomogeneous (appearance of "stones" H H 4 1 4 composite raw materials are reception use if filling is stiff or not L H 2 1
body. (user/patient) Supplier selection procedure [11]
ratio and/or "lumps") or too fluid, with varying appropriate for use QC inspection before releasing homogeneous)
Composite receipt files [12]
permittivity. finished pads
An unhomogeneous/stiff/uneven pad is IFUs [26,27,28]
C4.03 Operational ABC Discomfort (patient) H H 4 1 4 L H 2 1
positioned next to the patient's head. PMS report [29]
Electromagnetic/ ABC Excessive energy is delivered to the Local warmth (patient) M M 2 1 2 L M 1 1

C5.01
thermal energy ABC The pouch material is not chemically compatible body. Infinitesimal local warmth (patient) M L 1 1 1 L L 1 1
with the particles and/or solvent. Visual check before use (do not
Insufficient energy is delivered to the Dissatisfaction, loss of time
C5.02 Functional ABC Over time, the pad becomes inhomogeneous H H 4 1 4 use if filling is stiff or not M H 3 1
(appearance of "stones" and/or "lumps") or too stiff, homogeneous)
with varying permittivity. An unhomogeneous/stiff/uneven pad is
C5.03 Operational ABC Discomfort (patient) H H 4 1 4 M H 3 1
Discomfort, dissatisfaction, loss of

ABC H H 4 1 4 L H 2 1
time (user/patient)
Minor local skin irritation Pouch material properties are

B H H 4 2 9 L H 2 2
(user/patient) appropriate for use with
The patient's and/or user's skin is
specified particles and solvent
exposed to particles and/or solvent Severe eye/skin irritation, allergic
C5.04 B The pouch material is not chemically compatible H M 3 3 11 L M 1 3
material during product use or skin reaction (user/patient)
with the particles and/or solvent.
manipulation. Minor local skin irritation
Biocompatibility AC Solvent or particles pass through the pouch or the H L 2 2 6 L L 1 2
(user/patient)
pouch gets fragile and breaks resulting in a leakage
of solvent or particles. Severe eye/skin irritation, allergic
AC H L 2 3 10 L L 1 3
skin reaction (user/patient)
The patient's and/or user's airways are

exposed to particles and/or solvent Respiratory tract irritation, other Visual check before use (use
C5.05 ABC H H 4 3 12 L H 2 3
material during product use or limited health risks (user/patient) only if no leaks and pouch
manipulation. integrity intact and correctly Product design validation [1]
Discomfort, dissatisfaction, loss of sealed)
ABC H H 4 1 4 SAR simulation report [2] L H 2 1
time (user/patient) Safety warning concerning Stability report [3]
Supplier control
C5 - Selection of Minor local skin irritation contact with composite material Pouch technical specifications [5]
C - Conception B H H 4 2 9 Control of pouch material at L H 2 2
pouch material (user/patient) Supplier selection procedure [11]
reception
reception
The patient's and/or user's skin is Pouch receipt files [14]
Severe eye/skin irritation, allergic
B exposed to particles and/or solvent H M 3 3 11 IFUs [26,27,28] L M 1 3
C5.06 skin reaction (user/patient)
material during product use or PMS report [29]
The pouch material is too fragile.
manipulation. Minor local skin irritation Selection of a resistant pouch
Biocompatibility AC The resulting pad breaks leading to a leakage of H L 2 2 6 L L 1 2
(user/patient) material
solvent or particles.

AC H L 2 3 10 L L 1 3

exposed to particles and/or solvent Respiratory tract irritation, other
C5.07 ABC H H 4 3 12 L H 2 3
material during product use or limited health risks (user/patient)
manipulation.
Dissatisfaction, loss of time

A H H 4 1 4 M H 3 1
Insufficient energy is delivered to the (user/patient)
C5.08 Functional
body. Dissatisfaction, loss of time
The pouch material is not flexible enough and does
BC M H 3 1 3 L H 2 1
not fit the patient's head. (user/patient) Selection of a flexible pouch
There is too much space between the pad and the material
A Discomfort (patient) H H 4 1 4 M H 3 1
patient's head.
A stiff pad is positioned next to the
C5.09 Operational
patient's head.
BC Discomfort (patient) M H 3 1 3 M H 3 1
Minor local skin irritation

ABC M H 3 2 8 L L 1 2
The patient's and/or user's skin is (user/patient)
Selection of a biocompatible
C5.10 Biocompatibility The pouch material is not biocompatible. exposed to the pouch material during
Severe skin irritation, allergic skin pouch material
ABC product use or manipulation. M M 2 3 10 L L 1 3
reaction (user/patient)
ABC Local warmth (patient) M M 2 1 2 L M 1 1

C6.01 Visual check before use (do not
thermal energy The label on the pad peels off over time or the text body.
ABC Infinitesimal local warmth (patient) M L 1 1 1 use after expiry date and send L L 1 1
becomes unreadable.
back pad)
The pad is not identifiable and is misused (used on Insufficient energy is delivered to the Dissatisfaction, loss of time
C6.02 Functional ABC H H 4 1 4 Cleaning instructions L H 2 1
the wrong body part or after the expiry date). body. (user/patient)
Storage instructions
C6.03 Operational ABC The pad is wrongly positioned. Discomfort (patient) H H 4 1 4 L H 2 1
Discomfort, dissatisfaction, loss of Product design validation [1]

ABC H H 4 1 4 Supplier control L H 2 1
time (user/patient) SAR simulation report [2]
Additional label added in
Minor local skin irritation Stability report [3]
C6 - Selection of B H H 4 2 9 storage case (brand name, L H 2 2
C - Conception (user/patient) Selection of durable labels Label specifications [10]
label material reference, expiry date)
The patient's and/or user's skin is Supplier selection procedure [11]
Severe eye/skin irritation, allergic Only used by skilled
B exposed to particles and/or solvent H M 3 3 11 Visual check before use (use IFUs [26,27,28] L M 1 3
C6.04 The label on the pad peels off over time or the text skin reaction (user/patient) professionals
material during product use or only if no leaks and pouch PMS report [29]
becomes unreadable.
manipulation. Minor local skin irritation integrity intact and correctly
Biocompatibility AC The pad is used/kept on storage long after expiry H L 2 2 6 L L 1 2
(user/patient) sealed)
date. The pad gets fragile and break, leading to
Safety warning concerning
composite leakage. Severe eye/skin irritation, allergic
AC H L 2 3 10 contact with composite material L L 1 3

C6.05 ABC H H 4 3 12 L H 2 3
manipulation.

C7.01
thermal energy body.
ABC Inapropriate strength of the seals. Infinitesimal local warmth (patient) M L 1 1 1 L L 1 1
They get fragile and composite leaks gradually. Visual check before use
C7.02 Functional ABC Over time, the pad becomes inhomogeneous H H 4 1 4 (do not use if filling is stiff or not L H 2 1
with varying permittivity.
An unhomogeneous/stiff/uneven pad is
Sealing process validation [4]

ABC H H 4 1 4 Stability report [3] L H 2 1
time (user/patient)
Filling and Sealing processes work
Minor local skin irritation Sealing work instructions
B H H 4 2 9 instructions [21] L H 2 2
C - Conception C7 - Sealing process (user/patient) Sealing process validation QC inspection before releasing
Sealed filled pouch visual inspection work
The patient's and/or user's skin is finished pads
Severe eye/skin irritation, allergic instruction [22]
B exposed to particles and/or solvent H M 3 3 11 Visual check before use (use L M 1 3
C7.04 skin reaction (user/patient) IFUs [26,27,28]
material during product use or only if no leaks and pouch
Inapropriate strength of the seals. PMS report [29]
Biocompatibility AC They get fragile and break, leading to composite H L 2 2 6 L L 1 2
leakage.
Severe eye/skin irritation, allergic contact with composite material
AC H L 2 3 10 L L 1 3
C7.05 ABC H H 4 3 12 L H 2 3
manipulation.

C8.01
ABC Infinitesimal local warmth (patient) M L 1 1 1 Visual check before use (make L L 1 1
Inappropriate storage case for the pads that fold sure the material in your pad is
C8.02 Functional ABC during storage/shipment causing poor distribution H H 4 1 4 evenly distributed throughout L H 2 1
of the composite material. its plastic container, manually
level it if necessary)

A H H 4 1 4 L H 2 1
time (user/patient)
A H L 2 2 6 L L 1 2
(user/patient)
Design of a foam-filled case for
A H L 2 3 10 transport and storage of the pad Stability report [3] L L 1 3
when not in use Storage case specifications [9]
Discomfort, dissatisfaction, loss of The pad is held tight against the Transport resistance Report [25]
B M H 3 1 3 L H 2 1
time (user/patient) foam IFUs [26,27,28]
C8 - Selection of Minor local skin irritation Pouch cannot be bend for more PMS report [29]
C - Conception B exposed to particles and/or solvent M H 3 2 8 Visual check before use (use L H 2 2
packaging C8.04 (user/patient) than 20°
Inappropriate storage case for the pads that fold
manipulation. Severe eye/skin irritation, allergic integrity intact and correctly
Biocompatibility B during storage/shipment causing premature wear M M 2 3 10 L M 1 3
skin reaction (user/patient) sealed)
and tear.
C M H 3 1 3 contact with composite material L H 2 1
time (user/patient)
C M L 1 2 5 L L 1 2
(user/patient)

C M L 1 3 7 L L 1 3
The patient's and/or user's airways are Respiratory tract irritation, other
A H H 4 3 12 L H 2 3
exposed to particles and/or solvent limited health risks (user/patient)
C8.05
material during product use or Respiratory tract irritation, other
BC M H 3 3 11 L H 2 3
manipulation. limited health risks (user/patient)
Storage case specifications [9]

C8.06 ABC Minor skin injury (user/patient) M H 3 2 8 L H 2 2
Case is projected into the bore of the No magnetic component in Supplier control Supplier selection procedure [11]
Mechanical energy The storage case has a magnetic component.
MRI scanner. chosen storage case. Control of case at reception IFUs [26,27,28]
C8.07 ABC Major skin/bone injury (user/patient) M M 2 3 10 L M 1 3
PMS report [29]

C9.01 Visual check before use (make
ABC Infinitesimal local warmth (patient) M L 1 1 1 sure the material in your pad is L L 1 1
evenly distributed throughout
C9.02 Functional ABC H H 4 1 4 its plastic container, manually L H 2 1
The pad is wrongly positioned next to
the patient's head.

ABC H H 4 1 4 L H 2 1
time (user/patient)
Incorrect IFU/labeling content (indications for use, IFU approved by MRI experts
Minor local skin irritation Usability report [31]
B contraindications, warnings, storage conditions, H H 4 2 9 and Regulatory Affairs L H 2 2
C - Conception C9 - IFU/labeling text (user/patient) IFUs [26,27,28]
cleaning conditions) Only used by skilled
The patient's and/or user's skin is PMS report [29]
Severe eye/skin irritation, allergic professionals
C9.04 skin reaction (user/patient)
Biocompatibility AC H L 2 2 6 L L 1 2
AC H L 2 3 10 L L 1 3

C9.05 ABC H H 4 3 12 L H 2 3
manipulation.

S1.01 Choosing an unreliable supplier.
ABC Reception of raw materials that do not comply with Infinitesimal local warmth (patient) M L 1 1 1 L L 1 1
specifications (wrong particles / solvent). Insufficient energy is delivered to the Dissatisfaction, loss of time
S1.02 Functional ABC H H 4 1 4 L H 2 1
The resulting pad is inhomogeneous (appearance body. (user/patient)
of "stones" and/or "lumps") or too stiff, with varying
permittivity. An unhomogeneous/stiff/uneven pad is
S1.03 Operational ABC Discomfort (patient) H H 2 1 2 L H 2 1
positioned next to the patient's head. Visual check before use
(do not use if filling is stiff or not
ABC Local warmth (patient) M M 2 1 2 homogeneous) L M 1 1

S1.04
thermal energy The composite was badly mixed (not mixed enough body.
or incorrect proportions).
The resulting pad is inhomogeneous (appearance Insufficient energy is delivered to the Dissatisfaction, loss of time
S1.05 Functional ABC H H 4 1 4 L H 2 1
of "stones" and/or "lumps") or too stiff, with varying body. (user/patient)
permittivity.
S1.06 Operational ABC Discomfort (patient) H H 4 1 4 Product design validation [1] L H 2 1
Supplier control Stability report [3]
S - Supply-chain of
Discomfort, dissatisfaction, loss of Control of materials at reception Technical specifications [5,6,7,8,9,10]
raw materials and S1 - Selection of ABC H H 4 1 4 L H 2 1
time (user/patient) Traceability Supplier selection procedure [11]
intermediate suppliers
QC inspection before releasing Receipt files [12,13,14,15]
products Minor local skin irritation
B H H 4 2 9 finished pads IFUs [26,27,28] L H 2 2
(user/patient)
S1.07 Choosing an unreliable supplier. skin reaction (user/patient)
Reception of pouches that do not comply with
Biocompatibility AC specifications. H L 2 2 6 L L 1 2
The resulting pad breaks resulting in a leakage of
solvent or particles. Severe eye/skin irritation, allergic

S1.08 ABC H H 4 3 12 L H 2 3
manipulation.
S1.09 ABC Minor skin injury (user/patient) M H 3 2 8 L H 2 2

Choosing an unreliable supplier. The storage case Case is projected into the bore of the
Mechanical energy
has a magnetic component. MRI scanner.
S1.10 ABC Major skin/bone injury (user/patient) M M 2 3 10 L M 1 3

S2.01 The materials are not stored properly. Raw
ABC materials or composite material are degraded or a Infinitesimal local warmth (patient) M L 1 1 1 L L 1 1
Visual check before use (do not
foreign material is mixed in. Identification of materials at
use if filling is stiff or not Receipt files [12,13, 14, 15]
The resulting pad is inhomogeneous (appearance Insufficient energy is delivered to the Dissatisfaction, loss of time reception
S - Supply-chain of S2.02 Functional ABC H H 4 1 4 homogeneous) Storage work instructions [16, 17] L H 2 1
of "stones" and/or "lumps") or too stiff, with varying body. (user/patient) Storage conditions qualification
raw materials and Filling and Sealing processes work
S2 - Storage permittivity. Visual inspection of materials
intermediate An unhomogeneous/stiff/uneven pad is instructions [21]
S2.03 Operational ABC Discomfort (patient) H H 4 1 4 before filling pouches L H 2 1
products positioned next to the patient's head. IFUs [26,27,28]
QC inspection before releasing
PMS report [29]
finished pads
S2.04 ABC Minor skin injury (user/patient) M H 3 2 8 L H 2 2
The composite material is not stored properly. Pad is projected into the bore of the
Mechanical energy
Magnetic foreign material is mixed in. MRI scanner.
S2.05 ABC Major skin/bone injury (user/patient) M M 2 3 10 L M 1 3

P1.01
thermal energy ABC body. Infinitesimal local warmth (patient) M L 1 1 1 L L 1 1

P1.02 Functional ABC H H 4 1 4 L H 2 1
An unhomogeneous/stiff/uneven/ dirty
P1.03 Operational ABC pad is positioned next to the patient's Discomfort (patient) H H 4 1 4 L H 2 1
head.

ABC M H 3 1 3 L H 2 1
time (user/patient)
Visual inspection of the
The surface of the working environment is not Minor local skin irritation
B M H 3 2 8 environment at the start of the L H 2 2
clean. Foreign material inside or on the pouch (user/patient)
production process
surface. The field or patient pressure on the pad The patient's and/or user's skin is Manufacturing procedure [18]
Severe eye/skin irritation, allergic Cleaning phase of the pouch at
P1 - Preparation of B deteriorates pad integrity. exposed to particles and/or solvent M M 2 3 10 Sealed filled pouch visual inspection [22] L M 1 3
P - Production P1.04 skin reaction (user/patient) the end of the process
working environment material during product use or Operators training records [30]
QC inspection before releasing
manipulation. Minor local skin irritation PMS report [29]
Biocompatibility AC M L 1 2 5 finished pads L L 1 2
(user/patient)
Training sessions for
Severe eye/skin irritation, allergic manufacturing operators

AC M L 1 3 7 L L 1 3

P1.05 ABC M H 3 3 11 L H 2 3
manipulation.
P1.06 ABC Minor skin injury (user/patient) M H 3 2 8 L H 2 2

The surface of the working environment is not Pad is projected into the bore of the
Mechanical energy
Mechanical energy
clean. Magnetic foreign material inside the pad. MRI scanner.
P1.07 ABC Major skin/bone injury (user/patient) M M 2 3 10 L M 1 3
Pouch does not have the right dimensions and is

P2.01 Functional ABC too large, resulting in a thinner pad once composite H H 4 1 4 L H 2 1
is inserted.

Pouch does not have the right dimensions and is body. (user/patient)
too small, resulting in a rigid pad that does not
conform to the patient's head. An unhomogeneous/stiff/uneven pad is
P2.03 Operational ABC Discomfort (patient) H H 4 1 4 L H 2 1
Discomfort, dissatisfaction, loss of Pouch technical specifications [5]

ABC M H 3 1 3 Control of pouch dimensions L H 2 1
time (user/patient) Manufacturing procedure [18]
after sealing process
Minor local skin irritation Sealed filled pouch visual inspection [22]
P2 - Pouch B M H 3 2 8 QC inspection before releasing L H 2 2
P - Production (user/patient) Production sheet [23]
preparation finished pads
The patient's and/or user's skin is Operators training records [30]
Severe eye/skin irritation, allergic Training sessions for
B exposed to particles and/or solvent M M 2 3 10 Visual check before use (use IFUs [26,27,28] L M 1 3
P2.04 skin reaction (user/patient) manufacturing operators
Pouch does not have the right dimensions and is material during product use or only if no leaks and pouch PMS report [29]
too small, resulting in a mechanically weakened pad manipulation. Minor local skin irritation integrity intact and correctly
Biocompatibility AC M L 1 2 5 L L 1 2
once composite is inserted. Pad breaks during use, (user/patient) sealed)
resulting in a leakage of solvent or particles. Safety warning concerning
AC M L 1 3 7 L L 1 3

P2.05 ABC M H 3 3 11 L H 2 3
manipulation.
Inapropriate quantity of composite inserted in the Insufficient energy is delivered to the Dissatisfaction, loss of time
pouch, resulting in a thinner pad. body. (user/patient)

Inapropriate quantity of composite inserted in the
pouch, resulting in a thicker pad

ABC M H 3 1 3 L H 2 1
time (user/patient) Total weight measurement after Manufacturing procedure [18]
Minor local skin irritation sealing process Sealed filled pouch visual inspection [22]
P3 - Composite B M H 3 2 8 L H 2 2
(user/patient) QC inspection before releasing Production sheet [23]
P - Production insertion in the
The patient's and/or user's skin is finished pads Operators training records [30]
pouch Severe eye/skin irritation, allergic
B exposed to particles and/or solvent M M 2 3 10 Training sessions for Visual check before use (use IFUs [26,27,28] L M 1 3
P3.04 skin reaction (user/patient)
Inapropriate quantity of composite inserted in the material during product use or manufacturing operators only if no leaks and pouch PMS report [29]
pouch, resulting in a thicker pad. manipulation. Minor local skin irritation integrity intact and correctly
Biocompatibility AC M L 1 2 5 L L 1 2
Pad breaks during use, resulting in a leakage of (user/patient) sealed)
solvent or particles. Safety warning concerning
AC M L 1 3 7 L L 1 3

P3.05 ABC M H 3 3 11 L H 2 3
manipulation.
A H H 4 1 4 M H 3 1
Insufficient energy is delivered to the (user/patient)
Manufacturing procedure [18]
P4.01 Functional Thickness measurement Visual check before use (make
body. Dissatisfaction, loss of time Sealed filled pouch visual inspection [22]
BC M H 3 1 3 QC inspection before releasing sure the material in your pad is L H 2 1
P4 - Leveling The composite material in the pad is not evenly (user/patient) Production sheet [23]
P - Production finished pads evenly distributed throughout
process distributed and that does not fit the patient's head. Operators training records [30]
A Discomfort (patient) H H 4 1 4 Training sessions for its plastic container, manually M H 3 1
P4.02 Operational manufacturing operators level it if necessary)
BC Discomfort (patient) M H 3 1 3 M H 3 1

Electromagnetic/ Excessive energy is delivered to the Sealing process validation [4]
P5.01
thermal energy body. Stability report [3]
ABC Infinitesimal local warmth (patient) M L 1 1 1 Vacuum process before sealing L L 1 1
Manufacturing procedure [18]
Presence of air in the composite material leading to QC inspection before releasing Visual check before use (do not
Sealed filled pouch visual inspection [22]
inhomogeneities in the pad. Insufficient energy is delivered to the Dissatisfaction, loss of time Sealing process validation finished pads use if filling is stiff or not
P5.02 Functional ABC H H 4 1 4 Production sheet [23] L H 2 1
body. (user/patient) Training sessions for homogeneous)
Operators training records [30]
manufacturing operators
P5.03 Operational ABC Discomfort (patient) H H 4 1 4 PMS report [29] L H 2 1
ABC Local warmth (patient) M M 2 1 2 Sealing process validation [4] L M 1 1

P5.04 Stability report [3]
thermal energy The vacuum process is too short or the vacuum body. Vacuum process before sealing
ABC Infinitesimal local warmth (patient) M L 1 1 1 Manufacturing procedure [18] L L 1 1
system is flawed. QC inspection before releasing Visual check before use (do not
There is remaining air in the pouch. Insufficient energy is delivered to the Dissatisfaction, loss of time Sealing process validation finished pads use if filling is stiff or not
P5.05 Functional ABC H H 4 1 4 Production sheet [23] L H 2 1
Air bubbles lead to sedimentation of particles. body. (user/patient) Training sessions for homogeneous)
An inhomogeneous pad is used on a patient. manufacturing operators

P5.07
ABC Infinitesimal local warmth (patient) M L 1 1 1 Visual check before use (use L L 1 1
P - Production P5 - Vacuum process
only if no leaks and pouch
P5.08 Functional ABC H H 4 1 4 integrity intact and correctly L H 2 1
sealed)
ABC H H 4 1 4 Seal resistance tests every 3 Stability report [3] L H 2 1
The vacuum process is too long, resulting in time (user/patient)
months Manufacturing procedure [18]
powder residues on the seals.
Minor local skin irritation QC inspection before releasing Sealed filled pouch visual inspection [22]
B The seals are not resistant/are incomplete/have H H 4 2 9 Sealing process validation L H 2 2
(user/patient) finished pads Production sheet [23]
holes. The patient's and/or user's skin is
Training sessions for Operators training records [30]
A leaking pad is used on a patient. Severe eye/skin irritation, allergic
P5.10 manufacturing operators IFUs [26,27,28]
PMS report [29]
AC H L 2 3 10 L L 1 3

P5.11 ABC H H 4 3 12 L H 2 3
manipulation.

P6.01
Visual check before use (use
P6.02 Functional ABC H H 4 1 4 integrity intact and correctly L H 2 1
sealed)
Discomfort, dissatisfaction, loss of Annual calibration verification
ABC H H 4 1 4 Stability report [3] L H 2 1
time (user/patient) Seal resistance tests every 3
The sealing machine is not calibrated. Manufacturing procedure [18]
months
The seals are not resistant/are incomplete/have Minor local skin irritation Sealed filled pouch visual inspection [22]
B H H 4 2 9 Sealing Process Validation QC inspection before releasing L H 2 2
holes. (user/patient) Production sheet [23]
The patient's and/or user's skin is finished pads
A leaking pad is used on a patient. Operators training records [30]
Severe eye/skin irritation, allergic Training sessions for
P6.04 IFUs [26,27,28]
skin reaction (user/patient) manufacturing operators
PMS report [29]
AC H L 2 3 10 L L 1 3

P6.05 ABC H H 4 3 12 L H 2 3
manipulation.

P6.06
ABC Infinitesimal local warmth (patient) M L 1 1 1 Visual check before use (use L L 1 1
Insufficient energy is delivered to the Dissatisfaction, loss of time only if no leaks and pouch
body. (user/patient) integrity intact and correctly
sealed)

ABC H H 4 1 4 Cleaning phase of sealing Stability report [3] L H 2 1
time (user/patient)
There is powder residue on the sealing rubber. rubber before sealing Manufacturing procedure [18]
B The seals are not resistant/are incomplete/have H H 4 2 9 QC inspection before releasing Sealed filled pouch visual inspection [22] L H 2 2
(user/patient) Sealing Process Validation
P - Production P6 - Sealing process holes. finished pads Production sheet [23]
A leaking pad is used on a patient. Severe eye/skin irritation, allergic Training sessions for Operators training records [30]
P6.09 skin reaction (user/patient) manufacturing operators IFUs [26,27,28]
PMS report [29]
AC H L 2 3 10 L L 1 3
P6.10 ABC H H 4 3 12 L H 2 3
manipulation.

P6.11
Insufficient energy is delivered to the Dissatisfaction, loss of time only if no leaks and pouch
body. (user/patient) integrity intact and correctly
sealed)
Discomfort, dissatisfaction, loss of Seal resistance tests every 3 Stability report [3]
ABC H H 4 1 4 L H 2 1
The sealing time is too short or too long. time (user/patient) months Manufacturing procedure [18]
The seals are not resistant/are incomplete/have Minor local skin irritation QC inspection before releasing Sealed filled pouch visual inspection [22]
B H H 4 2 9 Sealing Process Validation L H 2 2
holes. (user/patient) finished pads Production sheet [23]
A leaking pad is used on a patient. The patient's and/or user's skin is Training sessions for Operators training records [30]
B exposed to particles and/or solvent H M 3 3 11 manufacturing operators Visual check before use (use IFUs [26,27,28] L M 1 3
material during product use or only if no leaks and pouch PMS report [29]

AC H L 2 3 10 L L 1 3

P6.15 ABC H H 4 3 12 L H 2 3
manipulation.

ABC H H 4 1 4 L H 2 1
time (user/patient)

B H H 4 2 9 L H 2 2
(user/patient)
B exposed to particles and/or solvent H M 3 3 11 L M 1 3
material during product use or
Presence of harmful material on the outer face of The pads are cleaned with water Safety warning concerning Manufacturing procedure [18]
Biocompatibility AC H L 2 2 6 and a clean cloth L L 1 2
the pad. (user/patient) contact with composite material Sealed filled pouch visual inspection [22]
P7 - Cleaning QC inspection before releasing Production sheet [23]
P - Production
process Severe eye/skin irritation, allergic finished pads Operators training records [30]
AC H L 2 3 10 L L 1 3
skin reaction (user/patient) Training sessions for IFUs [26,27,28]
manufacturing operators PMS report [29]
P7.02 ABC H H 4 3 12 L H 2 3
manipulation.
Presence of harmless material (dirt/water) on the An dirty pad is positioned next to the Discomfort, dissatisfaction, loss of
P7.03 Operational ABC H H 4 1 4 L H 2 1
outer face of the pad. patient's head. time (user/patient)

P8.01
thermal energy Mislabeling or missing label. body. Intended use
The pad is not identifiable and is misused (used on Visual check before use (do not
the wrong body part or after the expiry date). Insufficient energy is delivered to the Dissatisfaction, loss of time use after expiry date and send
P8.02 Functional ABC H H 4 1 4 One lot contains only identical L H 2 1
body. (user/patient) back pad)
products and lots are
P8.03 Operational ABC The pad is wrongly positioned. Discomfort (patient) H H 4 1 4 manufactured one by one L H 2 1
without ever mixing (line
Discomfort, dissatisfaction, loss of clearance) Label specifications [10]
ABC H H 4 1 4 L H 2 1
time (user/patient) QC inspection before releasing Manufacturing procedure [18]
Minor local skin irritation finished pads Sealed filled pouch visual inspection [22]
P8 - Labeling B H H 4 2 9 L H 2 2
P - Production (user/patient) Training sessions for Production sheet [23]
process
The patient's and/or user's skin is manufacturing operators Operators training records [30]
B exposed to particles and/or solvent H M 3 3 11 Label on pad Visual check before use (use IFUs [26,27,28] L M 1 3
Mislabeling or missing label. material during product use or Additional label added in only if no leaks and pouch PMS report [29]
The pad is used/kept on storage long after expiry manipulation. Minor local skin irritation storage case (brand name, integrity intact and correctly
date. The pad gets fragile and break, leading to (user/patient) reference, expiry date) sealed)
composite leakage. Only used by skilled Safety warning concerning
AC H L 2 3 10 professionals L L 1 3

P8.05 ABC H H 4 3 12 L H 2 3
manipulation.
Electromagnetic/ Excessive energy is delivered to the Visual check before use (make
P9.01
thermal energy body. sure the material in your pad is
evenly distributed throughout
Insufficient energy is delivered to the Dissatisfaction, loss of time its plastic container, manually
P9.02 Functional ABC H H 4 1 4 M H 3 1
body. (user/patient) level it if necessary / do not use
An unhomogeneous/stiff/uneven/ dirty if filling is stiff or not
P9.03 Operational ABC pad is positioned next to the patient's Discomfort (patient) H H 4 1 4 homogeneous) M H 3 1
head.
Discomfort, dissatisfaction, loss of QC inspection before releasing

ABC H H 4 1 4 Manufacturing procedure [18] L H 2 1
time (user/patient) finished pads (by different
person than manufacturing
P9 - Quality Control QC failure allowing defective products to be Minor local skin irritation Production sheet [23]
P - Production B H H 4 2 9 operator) L H 2 2
before release undetected. (user/patient) Operators training records [30]
Training sessions for
The patient's and/or user's skin is IFUs [26,27,28]
Severe eye/skin irritation, allergic manufacturing operators
B exposed to particles and/or solvent H M 3 3 11 Visual check before use (use PMS report [29] L M 1 3
P9.04 skin reaction (user/patient) Traceability
AC H L 2 3 10 L L 1 3

P9.05 ABC H H 4 3 12 L H 2 3
manipulation.

P10.01
Pads are incorrectly placed in storage case and sure the material in your pad is
P10.02 Functional ABC folded during storage/shipment causing poor H H 4 1 4 evenly distributed throughout L H 2 1
distribution of the composite material. its plastic container, manually

A H H 4 1 4 L H 2 1
time (user/patient)
A H L 2 2 6 L L 1 2
(user/patient)
Design of a foam-filled case for Stability report [3]
A H L 2 3 10 transport and storage of the pad Manufacturing procedure [18] L L 1 3
skin reaction (user/patient) Foam size control before
when not in use Operators training records [30]
conditioning
Discomfort, dissatisfaction, loss of The pad is held tight against the Case and foam preparation protocol [24]
B M H 3 1 3 Training sessions for L H 2 1
time (user/patient) foam Transport resistance Report [25]
The patient's and/or user's skin is manufacturing operators
Minor local skin irritation Pouch cannot be bend for more IFUs [26,27,28]
B exposed to particles and/or solvent M H 3 2 8 Visual check before use (use L H 2 2
P10.04 (user/patient) than 20° PMS report [29]
Pads are incorrectly placed in storage case and
manipulation. Severe eye/skin irritation, allergic integrity intact and correctly
Biocompatibility B folded during storage/shipment causing premature M M 2 3 10 L M 1 3
skin reaction (user/patient) sealed)
wear and tear.
C M H 3 1 3 contact with composite material L H 2 1
time (user/patient)
C M L 1 2 5 L L 1 2
(user/patient)

C M L 1 3 7 L L 1 3
P - Production P10 - Conditioning skin reaction (user/patient)
A H H 4 3 12 L H 2 3
P10.05
BC M H 3 3 11 L H 2 3

P10.06 Mixing of products.
thermal energy body. Intended use
ABC The wrong product is placed on the storage case. Infinitesimal local warmth (patient) M L 1 1 1 L L 1 1
Visual check before use (do not
The pad is misused (used on the wrong body part or
Insufficient energy is delivered to the Dissatisfaction, loss of time use after expiry date and send
P10.07 Functional ABC after the expiry date). H H 4 1 4 One lot contains only identical L H 2 1
body. (user/patient) back pad)
products and lots are
P10.08 Operational ABC The pad is wrongly positioned. Discomfort (patient) H H 4 1 4 manufactured one by one L H 2 1
without ever mixing (line
Discomfort, dissatisfaction, loss of clearance) Label specifications [10]
ABC M H 3 1 3 L H 2 1
time (user/patient) Training sessions for Manufacturing procedure [18]
Minor local skin irritation manufacturing operators Production sheet [23]
B M H 3 2 8 L H 2 2
(user/patient) Label on pad Case and foam preparation protocol [24]
The patient's and/or user's skin is Additional label added in Operators training records [30]
B exposed to particles and/or solvent M M 2 3 10 storage case (brand name, Visual check before use (use IFUs [26,27,28] L M 1 3
P10.09 Mixing of products. skin reaction (user/patient)
material during product use or reference, expiry date) only if no leaks and pouch PMS report [29]
The wrong product is placed on the storage case.
manipulation. Minor local skin irritation Labels verification and matching integrity intact and correctly
Biocompatibility AC The pad is used/kept on storage long after expiry M L 1 2 5 L L 1 2
(user/patient) during conditioning sealed)
date. The pad gets fragile and break, leading to
Only used by skilled Safety warning concerning
composite leakage. Severe eye/skin irritation, allergic
AC M L 1 3 7 professionals contact with composite material L L 1 3

P10.10 ABC M H 3 3 11 L H 2 3
manipulation.

F1.01
ABC The case containing the pads is stored in poor Infinitesimal local warmth (patient) M L 1 1 1 Visual check before use (make L L 1 1
conditions at Multiwave's site (excessive sure the material in your pad is

F1.02 Functional ABC temperature, wrong position or excessive H H 4 1 4 evenly distributed throughout L H 2 1
manipulations of the case) causing poor its plastic container, manually
distribution of the composite material. level it if necessary)
F1.03 Operational ABC Discomfort (patient) H H 4 1 4 L H 2 1
Design of a foam-filled case for Stability report [3]
Discomfort, dissatisfaction, loss of transport and storage of the pad Foam size control before Manufacturing procedure [18]
ABC H H 4 1 4 L H 2 1
time (user/patient) when not in use conditioning Case and foam preparation protocol [24]
F - Supply-chain of
F1 - Storage Minor local skin irritation The pad is held tight against the Storage work instructions Operators training records [30]
finished products B H H 4 2 9 L H 2 2
(user/patient) foam Training sessions for Transport resistance Report [25]
Severe eye/skin irritation, allergic Pouch cannot be bend for more manufacturing operators IFUs [26,27,28]
F1.04 The case containing the pads is stored in poor than 20° PMS report [29]
conditions at Multiwave's site (excessive
Biocompatibility AC temperature, wrong position or excessive H L 2 2 6 L L 1 2
manipulations of the case) causing premature wear
and tear. Severe eye/skin irritation, allergic

F1.05 ABC H H 4 3 12 L H 2 3
manipulation.

F2.01
External packaging/pads case damaged during
sure the material in your pad is
extreme transportation conditions Insufficient energy is delivered to the Dissatisfaction, loss of time
F2.02 Functional ABC H H 4 1 4 evenly distributed throughout L H 2 1
and handling causing poor distribution of the body. (user/patient)
its plastic container, manually
composite material of the pads.
F2.03 Operational ABC Discomfort (patient) H H 4 1 4 L H 2 1
External packaging/pads case damaged during

extreme transportation conditions An dirty pad is positioned next to the Discomfort, dissatisfaction, loss of Design of a foam-filled case for Foam size control before
F2.04 Operational ABC H H 4 1 4 Cleaning instructions L H 2 1
and handling causing presence of harmless patient's head. time (user/patient) transport and storage of the pad conditioning Manufacturing procedure [18]
material (dirt/water) on the outer face of the pad. when not in use Training sessions for Operators training records [30]
The pad is held tight against the manufacturing operators Transport resistance Report [25]
ABC H H 4 1 4 foam Transportation subcontractor IFUs [26,27,28] L H 2 1
time (user/patient)
Minor local skin irritation Plastic pouch does not allow selection PMS report [29]
B H H 4 2 9 bending higher than 20° Agreement? L H 2 2
(user/patient)
F - Supply-chain of
F2 - Transportation The patient's and/or user's skin is
finished products Severe eye/skin irritation, allergic
F2.05 skin reaction (user/patient)
External packaging/pads case damaged during material during product use or only if no leaks and pouch
extreme transportation conditions manipulation. Minor local skin irritation integrity intact and correctly
and handling causing premature wear and tear of (user/patient) sealed)
the pads. Safety warning concerning

F2.06 ABC H H 4 3 12 L H 2 3
manipulation.
Label on pad
ABC Local warmth (patient) M M 2 1 2 Additional label added in L M 1 1
F2.07 storage case (brand name,
ABC Infinitesimal local warmth (patient) M L 1 1 1 reference, expiry date) Label specifications [10] L L 1 1
Error in shipment.
Transportation subcontractor Intended use IFUs [26,27,28]
The pad is misused (used on the wrong body part). Insufficient energy is delivered to the Dissatisfaction, loss of time
F2.08 Functional ABC H H 4 1 4 selection PMS report [29] L H 2 1
Agreement?
g
F2.09 Operational ABC The pad is wrongly positioned. Discomfort (patient) H H 4 1 4 Only used by skilled L H 2 1
professionals

U1.01 Do not fold
The pad is repeatedly folded for better positioning, Insufficient energy is delivered to the Dissatisfaction, loss of time sure the material in your pad is
U1.02 Functional ABC H H 4 1 4 M H 3 1
causing poor distribution of the composite material. body. (user/patient) evenly distributed throughout
U1.03 Operational ABC Discomfort (patient) H H 4 1 4 level it if necessary) M H 3 1

A H H 4 1 4 M H 3 1
time (user/patient)
A H L 2 2 6 M L 1 2
(user/patient)

A H L 2 3 10 M L 1 3
Plastic pouch is resistant to Stability report [3]

B M H 3 1 3 multiple bending without Only used by skilled Usability report [31] L H 2 1
time (user/patient)
The patient's and/or user's skin is breaking or weakening (does not professionals IFUs [26,27,28]
Minor local skin irritation Do not fold the pad
B exposed to particles and/or solvent M H 3 2 8 allow bending higher than 20°) PMS report [29] L H 2 2
U1.04 (user/patient) Visual check before use (use
The pad is repeatedly folded for better positioning, manipulation. Severe eye/skin irritation, allergic
Biocompatibility B M M 2 3 10 integrity intact and correctly L M 1 3
causing premature wear and tear. skin reaction (user/patient)
sealed)
Discomfort, dissatisfaction, loss of Safety warning concerning
C M H 3 1 3 L H 2 1
time (user/patient) contact with composite material
C M L 1 2 5 L L 1 2
(user/patient)

C M L 1 3 7 L L 1 3
A H H 4 3 12 M H 3 3
U1.05
BC M H 3 3 11 L H 2 3
ABC Local warmth (patient) H M 3 1 3 L M 1 1

Excessive energy is delivered to the
U1.06
Electromagnetic/ incorrect body part.
ABC Infinitesimal local warmth (patient) H L 2 1 2 L L 1 1
thermal energy
Excessive energy is delivered to the Pads positioning instructions Usability report [31]
U1.07 ABC Wrong placement (body location or position) of the Infinitesimal local warmth H M 3 1 3 Only used by skilled L M 1 1
eyes. Safety warning (never cover the IFUs [26,27,28]
pads. professionals
Insufficient energy is delivered to the Dissatisfaction, loss of time eyes) PMS report [29]
U1.08 Functional ABC H H 4 1 4 M H 3 1
zone of interest. (user/patient)
U1.09 Operational ABC The pad is wrongly positioned. Discomfort (patient) H H 4 1 4 M H 3 1
ABC Local warmth (patient) M M 2 1 2 M M 2 1

U - Clinical use U1 - MRI scan Electromagnetic/ Excessive energy is delivered to the
U1.10
ABC Infinitesimal local warmth (patient) M L 1 3 7 Visual check before use (do not M L 1 3
The pad is used after the expiry date. use after expiry date and send
U1.11 Functional ABC H H 4 1 4 back pad) H H 4 1
The pad is wrongly positioned next to

U1.12 Operational ABC Discomfort (patient) H H 4 1 4 H H 4 1
the patient's head.

ABC H H 4 1 4 M H 3 1
time (user/patient)
Minor local skin irritation Usability report [31]

B H H 4 2 9 Only used by skilled M H 3 2
(user/patient) IFUs [26,27,28]
professionals
B exposed to particles and/or solvent H M 3 3 11 Visual check before use (use M M 2 3
U1.13 skin reaction (user/patient)
The pad is used after the expiry date. The pad gets manipulation. Minor local skin irritation integrity intact and correctly
Biocompatibility AC H L 2 2 6 M L 1 2
fragile and break, leading to composite leakage. (user/patient) sealed)
AC H L 2 3 10 M L 1 3

U1.14 ABC H H 4 3 12 M H 3 3
manipulation.

ABC H H 4 1 4 M H 3 1
time (user/patient)

B H H 4 2 9 M H 3 2
(user/patient)
B exposed to particles and/or solvent H M 3 3 11 Visual check before use (use M M 2 3
U1.15 skin reaction (user/patient)
material during product use or only if no leaks and pouch Stability report [3]
Plastic pouch is resistant to
The pad is mishandled (bursting or piercing) leading manipulation. Minor local skin irritation Only used by skilled integrity intact and correctly Usability report [31]
Biocompatibility AC H L 2 2 6 bursting and piercing from the M L 1 2
to composite leakage. (user/patient) professionals sealed) IFUs [26,27,28]
environnement
Safety warning concerning PMS report [29]
AC H L 2 3 10 M L 1 3

U1.16 ABC H H 4 3 12 M H 3 3
manipulation.

AC H H 4 1 4 Warning to add "pads may Stability report [3] H H 4 1
Chemical reaction between heavy water and plastic (user/patient)
Only used by skilled become visible in the MR images Usability report [31]
U1.17 Functional pouch over time. Pads are visible in MR diagnostic image. Wrong diagnostic leading to
professionals over time due to chemical IFUs [26,27,28]
AC Normal water appears inside Pad. inadequate treatment or H M 3 3 11 H L 2 3
reaction" PMS report [29]
unnecessary additional tests

U2.01
thermal energy body. Storage instructions
ABC The case containing the pads is stored in poor Infinitesimal local warmth (patient) M L 1 1 1 L L 1 1
Visual check before use (make
conditions at customer's site (excessive
Insufficient energy is delivered to the Dissatisfaction, loss of time sure the material in your pad is
U2.02 Functional ABC temperature, wrong position or excessive H H 4 1 4 M H 3 1
body. (user/patient) evenly distributed throughout
manipulations of the case) causing poor
distribution of the composite material.
An unhomogeneous/stiff/uneven pad is level it if necessary)
U2.03 Operational ABC Discomfort (patient) H H 4 1 4 M H 3 1
Design of a foam-filled case for
Discomfort, dissatisfaction, loss of transport and storage of the pad Stability report [3]
ABC H H 4 1 4 M H 3 1
time (user/patient) when not in use Usability report [31]
Only used by skilled
U - Clinical use U2 - Storage Minor local skin irritation The pad is held tight against the Transport resistance Report [25]
B H H 4 2 9 professionals M H 3 2
(user/patient) foam IFUs [26,27,28]
Storage instructions
The patient's and/or user's skin is Pouch cannot be bend for more PMS report [29]
The case containing the pads is stored in poor Severe eye/skin irritation, allergic Visual check before use (use
B exposed to particles and/or solvent H M 3 3 11 than 20° M M 2 3
U2.04 conditions at customer's site (excessive skin reaction (user/patient) only if no leaks and pouch
Biocompatibility temperature, wrong position or excessive integrity intact and correctly
AC manipulations of the case) causing premature wear H L 2 2 6 sealed) M L 1 2
(user/patient)
and tear. Safety warning concerning
AC H L 2 3 10 M L 1 3
Respiratory tract irritation, other
U2.05 ABC exposed to particles and/or solvent H H 4 3 12 M H 3 3
limited health risks (user/patient)
Discomfort, dissatisfaction
ABC M H 3 1 3 L H 2 1
(user/patient)
The patient's and/or user's airways Minor local skin irritation
ABC Use of inappropriate cleaning products causing M M 2 2 6 Usability report [31] L M 1 2
and/or skin are exposed to harmful (user/patient) Only used by skilled
U3.01 Biocompatibility presence of harmful product on the outer face of Cleaning instructions IFUs [26,27,28]
products during product use or Severe eye/skin irritation, allergic professionals
the pad. PMS report [29]
manipulation. skin reaction, respiratory tract
ABC M M 2 3 10 L M 1 3
irritation, other limited health risks
(user/patient)

U3.02
thermal energy Use of inappropriate cleaning products causing body.
alteration of physical and chemical properties of Cleaning instructions
the pouch material. Insufficient energy is delivered to the Dissatisfaction, loss of time Visual check before use (do not
U3.03 Functional ABC Over time, the pad becomes inhomogeneous H H 4 1 4 use if filling is stiff or not L H 2 1
with varying permittivity. An unhomogeneous/stiff/uneven pad is
U3.04 Operational ABC Discomfort (patient) H H 4 1 4 L H 2 1

ABC H H 4 1 4 L H 2 1
U - Clinical use U3 - Cleaning time (user/patient) Pouch technical specifications [5]
Minor local skin irritation Pouch material resistant to Only used by skilled
B H H 4 2 9 Usability report [31] L H 2 2
(user/patient) chemical stress professionals
IFUs [26,27,28]
Severe eye/skin irritation, allergic Cleaning instructions
Use of inappropriate cleaning products causing PMS report [29]
B exposed to particles and/or solvent H M 3 3 11 L M 1 3
U3.05 skin reaction (user/patient) Visual check before use (use
alteration of physical and chemical properties of material during product use or
the pouch material. manipulation. Minor local skin irritation
Biocompatibility AC H L 2 2 6 integrity intact and correctly L L 1 2
Solvent or particles pass through the pouch or the (user/patient)
sealed)
pouch gets fragile and breaks resulting in a leakage
Severe eye/skin irritation, allergic Safety warning concerning
AC of solvent or particles. H L 2 3 10 L L 1 3
skin reaction (user/patient) contact with composite material

U3.06 ABC H H 4 3 12 L H 2 3
manipulation.
Pads are not cleaned between patients. The patient's and/or user's are exposed Usability report [31]
Viral or bacterial infection Only used by skilled
U3.07 Biocompatibility ABC Presence of body fluids or pathogens on the outer to pathogens during product use or M M 2 3 10 Cleaning instructions IFUs [26,27,28] L M 1 3
(user/patient) professionals
surface of the pad. manipulation. PMS report [29]

ABC H H 4 1 4 M H 3 1
time (user/patient)

B H H 4 2 9 M H 3 2
(user/patient)
The user's skin is exposed to particles Severe eye/skin irritation, allergic only if no leaks and pouch
B H M 3 3 11 M M 2 3
R1.01 and/or solvent material during product skin reaction (user/patient) integrity intact and correctly
manipulation. sealed)
Minor local skin irritation Only used by skilled
Biocompatibility AC H L 2 2 6 Disposal instructions (send back M L 1 2
(user/patient) professionals
pad if defective or after expiry Usability report [31]
R1 - Defective or end-of-life pads are disposed in a non-
R - Product returns Severe eye/skin irritation, allergic date) IFUs [26,27,28]
Disposal/recycling AC appropriate way. H L 2 3 10 M L 1 3
skin reaction (user/patient) Safety warning concerning PMS report [29]
contact with composite material
The user's airways are exposed to

Respiratory tract irritation, other
R1.02 ABC particles and/or solvent material during H H 4 3 12 M H 3 3
limited health risks (user/patient)
product manipulation.
Only used by skilled Disposal instructions (send back

Composite material released into the professionals pad if defective or after expiry
R1.03 Chemical ABC Pollution (environment) H H 4 2 9 M H 3 2
environment. Traceability of pads sold date, do not dispose of the pads
(reminder to customer) yourself)
#N/A
Device: A Initial risk cotation Severity Device: A Residual risk cotation Severity
1 2 3 1 2 3
1 27 4 7 1 59 29 37
2 32 24 30 2 81 4 23
Occurrence Occurrence
3 7 5 5 3 19 1 5
4 96 1 23 4 3 0 0
Total risks nb 261 Total risks nb 261
Worst risk Quot Nb Worst risk Quot Nb

12 23 11 5
Mean 5.4 Mean 3.9
Device: B Initial risk cotation Severity Device: B Residual risk cotation Severity
1 2 3 1 2 3
1 27 0 3 1 59 2 33
2 32 1 14 2 84 27 27
3 14 12 27 3 16 5 4
4 88 21 20 4 2 0 0

12 23 11 5
Mean 5.8 Mean 4.0
Device: C Initial risk cotation Severity Device: C Residual risk cotation Severity
1 2 3 1 2 3
1 27 7 10 1 59 29 37
2 32 21 27 2 84 4 24
3 14 5 8 3 16 1 4
4 89 1 20 4 3 0 0

12 23 11 5
Mean 5.3 Mean 3.9

Accept
B/R
ment according
Benefit/risk ratio
agement plan
Residual Other risk

Expected Benefice criteria Benefice/Risque Ratio
Risk generated
P1 reduced? P2 reduced?
Enhancement of the B1+ field in the vicinity of the

1 N Favorable YES
pads leading to images that may help for
1 N Ditto Favorable YES
1 N YES

3 N Ditto Favorable
5 N Ditto Favorable YES YES
7 N Ditto Favorable YES YES



3 N Ditto Favorable





2 N Ditto Favorable
7 N Ditto Favorable
4 N Ditto Favorable
4 N Ditto Favorable

4 N Ditto Favorable


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D2.2 Risk Analysis

3.7.7 Overall residual risk acceptability criteria ....................................................................... 19

- Risk management plan (present document) : TF-510 Risk management plan

- Risk management report: TF-530 Risk management report

3 TF-510 RISK MANAGEMENT PLAN

Writer Zo RAOLISON Material Science Engineer

The risk management file is organized into several parts:

- Risk management plan

- Usability Engineering file

3.3 SCOPE OF THE RISK MANAGEMENT PLAN

- The characteristics of the medical device

3.4 RESPONSIBILITIES AND AUTHORITIES

Name Company Function Responsibilities Authorities Competencies

Multiwave Expert, writer and

Multiwave Expert, writer and

Kaizad Multiwave Expert and

Director of Accountable for

3.5 PRODUCT DEFINITION

Figure 1. Two PADS 7TNS

3.5.2 Intended use

3.5.3 Indications for use

3.5.4 Expected performance

3.5.5 Preliminary hazard analysis

N° Question wording Answer

C.2.2 Is the medical device intended to be implanted? No.

N° Question wording Answer

- Whether characteristics relevant to safety are known;

C.2.6 Are substances delivered to or extracted from the patient? No.

N° Question wording Answer

skin humidity. It will also generate a slight

N° Question wording Answer

Factors that should be considered include:

N° Question wording Answer

user by the manufacturer or will it involve the participation

N° Question wording Answer

C.2.29.6 Is the medical device controlled by a menu? No.

N° Question wording Answer

Factors that should be considered include the consequence

3.5.6 Medical device life cycle steps

Step Main activities Participants

Step Main activities Participants

3.6 RISK ANALYSIS

3.6.2 Risk control options

1. Inherent safety by design;

3.6.3 Risk quotation criteria

3.6.4 The severity scale

Severity level Description Possible harm to user/patient

Reversible light alteration requiring • Minor skin injury

3.6.5 The probability of occurrence scale

Probability level Qualitative likelihood Quantitative likelihood

- The probability of a hazardous situation occurring (P1)

3.6.6 Risk acceptability Criteria

Negligible risk (1-7)

Acceptable risk (8-11)

Unacceptable risk (12)

3.6.7 Risk-benefit evaluation criteria

Medical Device Benefits are:

3.7 Verification and evaluation of overall residual risk

3.7.1 Review of all residual risks

3.7.2 Method used to analyze overall residual risk

3.7.3 Review for conflicting requirements