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CE
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5 Risk Management Report

(According to EN ISO 14971: 2019)

File No.: CE

Version: A/0

Product: Hip orthosis/Knee orthosis/Knee/ankle/foot orthosis

Technical File Doc. No. CE

Ver. A/0

Chapter One Review

1.1 Product Introduction

Please refer to Section 1.1 Device description and specification.

1.1.1 Product Name

Lower Limb Brace

1.1.2 Product Function

Please refer to Section 1.1 Device description and specification.

1.1.3 Product Picture, Configuration and Material

Please refer to Section 1.1 Device description and specification.

1.1.4 Clinical Background, current knowledges and state of art

Please refer to Clinical evaluation report Section 3. Clinical background, current

knowledge, state of the art.

1.2 Standard List

Regulations/Directive
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- Medical Device Regulation: Regulation (EU) 2017/745

Guidance

- MEDDEV 2.7.1 revision 4 Clinical evaluation: A guide for manufacturers and notified
bodies

- MEDDEV 2.12-1 rev 8 guidelines on a medical devices vigilance system

- MEDDEV 2.12-2 guidelines on post market clinical follow-up

Applicable Standard

Please refer to Section 1.1 about Applicable Standard.

1.3 Risk Management Plan (According to ISO/TR 24971:2020 clause 4.4)

1) Plan the scope of risk management activities

The risk management plan is mainly for the product in its entire life cycle (including design
development, product realization, the final stop and disposal stage) for risk management
activities of planning.

2) Formulation of responsibility and power-refer to the fifth section in Chapter one.

3) Assessment requirements for risk management activities I) whether the risk management
plan has been properly implemented Review team members are responsible for the
implementation of the risk management plan to verify, to view the risk management
document, to view the risk analysis, risk assessment, risk control and other record, to ensure
that the risk management plan of risk management activities have been properly
implemented. Verification of the effectiveness of risk management activities for II The
evaluation group can be used to verify the effectiveness of the risk management activities by
collecting clinical data and information on the production and production of the risk
management.

4) The acceptable critIeria for risk acceptability are determined by the manufacturer to
determine the acceptable risk criteria for determining the risk acceptable to the first section
of the second chapter.

5) Verification activities – refer to Technical file Section 6 Verification and Validation Data.

6) Activities related to the collection and evaluation of information related to the production
and production after production – Refer to Technical file Section 7 Post Market Surveillance.

7) This risk management plan is in accordance with all requirements listed in appendix F of
EN ISO 14971. Its task is to describe the risk management process for the concerned product
to identify potential risks, evaluate them and to control them effectively. This risk
management plan describes the risk management process of the manufacturer for the
above-mentioned medical device. It covers all phases of the life cycle, starting with the
concept (design and development control), production, storage / dispatch up to
decommissioning or waste disposal in accordance with EN ISO 14971 Appendix F.1and F.2.

In this risk management plan the following areas are covered:

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---Description of the medical device and designation of the performance properties

---Designation of personnel, responsibilities and competence within the risk management

process

---Evaluation of the risk management process through the management

---Criteria for the acceptability of risks

---Flow chart of the risk management process

8) Personnel and Responsibilities in the Risk Management Process

The personnel and responsibilities in the risk management process was designated in
chapter 4.

9) Criteria to Analyze and Evaluate the Acceptability of Risk

Acceptance Criteria

Qualitative severity levels

Probability 1. Negligible 2. Minor 3. Serious 4. Critical 5. Catastrophic
5. Frequent NAC NAC NAC NAC NAC
4. Probable NAC NAC NAC NAC NAC
3. Occasional AC NAC NAC NAC NAC
2. Remote AC AC NAC NAC NAC
1. Improbable AC AC AC NAC NAC
NAC = unacceptable AC = acceptable

The estimated risk to each hazard/ reason is written list with the form of classification
(NAC/AC), give clear indication if it has control measures.

Identification of qualitative and quantitative characteristics (According to ISO/TR 24971:2020

Annex A).

Item Questions Answer/Comments

A.2.1 What is the intended use and how is the
medical device to be used?
A.2.2 Is the medical device intended to be
implanted?
A.2.3 Is the medical device intended to be in
contact with the patient or other persons?
A.2.4 What materials or components are utilized
in the medical device or are used with, or
are in contact with, the medical device?
A.2.5 Is energy delivered to or extracted from
the patient?
A.2.6 Are substances delivered to or extracted
from the patient?
A.2.7 Are biological materials processed by the
medical device for subsequent re-use,
transfusion or transplantation?
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A.2.8 Is the medical device supplied sterile or

intended to be sterilized by the user, or
are other microbiological controls applicable?
A.2.9 Is the medical device intended to be
routinely cleaned and disinfected by the
user?
A.2.10 Does the medical device modify the
patient environment?
A.2.11 Are measurements taken?
parA.2.12 Is the medical device interpretative?
A.2.13 Is the medical device intended for use in
conjunction with other medical devices,
medicines or other medical technologies?
A.2.14 Are there unwanted outputs of energy or
substances?
A.2.15 Is the medical device susceptible to
environmental influences?
A.2.16 Does the medical device influence the
environment?
A.2.17 Does the medical device require
consumables or accessories?
A.2.18 Is maintenance or calibration necessary?
A.2.19 Does the medical device contain
software?
A.2.20 Does the medical device allow access to
information?
A.2.21 Does the medical device store data critical
to patient care?
A.2.22 Does the medical device have a restricted
shelf-life?
A.2.23 Are there any delayed or long-term use
effects?
A.2.24 To what mechanical forces will the medical
device be subjected?
A.2.25 What determines the lifetime of the medical
device?
A.2.26 Is the medical device intended for single
use?
A.2.27 Is safe decommissioning or disposal of
the medical device necessary?
A.2.28 Does installation or use of the medical
device require special training or special
skills?

A.2.29 How will information for safety be

provided?

A.2.30 Are new manufacturing processes

established or introduced?

A.2.31 Is successful application of the medical

device critically dependent on the usability
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of the user interface?

A.2.31.1 Can the user interface design features
contribute to use error?
A.2.31.2 Is the medical device used in an
environment where distractions can cause
use error?
A.2.31.3 Does the medical device have connecting
parts or accessories?
A.2.31.4 Does the medical device have a control
interface?
A.2.31.5 Does the medical device display
information?
A.2.31.6 Is the medical device controlled by a
menu?
A.2.31.7 Is the successful use of the medical device
dependent on a user’s knowledge, skills and
abilities?
A.2.31.8 Will the medical device be used by
persons with special needs?
A.2.31.9 Can the user interface be used to initiate
unauthorized actions?
A.2.32 Does the medical device include an alarm
system?
A.2.33 In what way(s) might the medical device
be misused (deliberately or not)?
A.2.34 Is the medical device intended to be
mobile or portable?
A.2.35 Does the use of the medical device
depend on essential performance?
A.2.36 Does the medical device have a degree of
autonomy?
A.2.37 Does the medical device produce an
output that is used as an input in
determining clinical action?

10) Controlling of the Management Process

The risk management will be achieved continuously, to analyze the experience achieved
with the product in question, to evaluate the risk situation and to document this
appropriately in the risk management worksheet. If necessary, or in case of special incidents,
the management or its deputy will initiate an extraordinary meeting with responsible
person. The management controls include the evaluation of actions taken as well as the
success of these actions. It includes also the evaluation of available information about
competitors' products.

11) Controlling of the risk analysis process

The flow chart describes the levels of realization of the management process and designates
single steps for the risk analysis, risk evaluation, action management and the risk controlling.

The flow chart is seen <Figure B.1 — Overview of risk management activities as applied to
medical devices> of EN ISO14971:2019.
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Step 1: Intended Use and Identification of Characteristics Related to the Safety of the
Medical Device (According to ISO/TR 24971:2020 clause 5.2)

The intended use and each reasonably imaginable and foreseeable misuse will be described
in the risk management plan together with the product performance properties, which may
influence the safety of the medical device. Then, the performance properties will be taken
over into the risk management worksheet and the risks will be evaluated which occur if
these performance properties are not achieved. For describing the features of the medical
device and its environment in which it is used, Annex C of the current standard ISO/TR
24971:2020 is applied.

Step 2: Identification of Hazards (According to ISO/TR 24971:2020 clause 5.4)

All known and foreseeable failures / dysfunctions / hazards, which infringe the function and
safety of the medical device, will be identified. For this the medical device will be analyzed in
its regular mode, failure mode, (also in case of reasonably foreseeable misuse). Moreover,
already earlier discovered hazards, incidents or situations will be considered.

Step 3: Estimation of the Risk(s) for Each Hazardous Situation (According to

ISO/TR 24971:2020 clause 5.4)

For each defined or assumed hazard of Step 2 the implied risk will be assessed. The expected
physical damage or severity of harm, and probability of occurrence. Reasonably foreseeable
sequences or combinations of events that can result in a hazardous situation will be
considered and the resulting hazardous situation(s) will be recorded.

Step 4: Risk Evaluation (According to ISO/TR 24971:2020 clause 6)

After that each risk will be evaluated, whether it is acceptable or not and whether a risk
reduction is required. The criteria to evaluate the acceptability are listed in the risk
management plan.

Step 5 and 6: Adopt risk control measures (According to ISO/TR 24971:2020 clause 7.2)

For risks which are within the acceptable area no actions of risk control will be taken.
Risks, which are outside this area, will be treated case by case. Any risk control measures
have the goal to reach at least the “AC” (Acceptable).

The effectiveness of the risk control measures taken will be evaluated/verified and
recorded in the risk management worksheet.

Step 7: Residual Risk Evaluation (According to ISO/TR 24971:2020 clause 7.2)

The residual risks will be evaluated and documented in the risk management worksheet.
In case a residual risk is not acceptable, Step 5 and step6 will be repeated.

Step 8: Risk / Benefit Analysis (According to ISO/TR 24971:2020 clause 7.4)

Not acceptable risks can be accepted in exceptional cases, if a particularly high benefit
is to be expected for the patient, and alternative products or treatment measures with
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minor risks are not available.

Step 9: Risks Arising from Risk Control Measures (According to ISO/TR 24971:2020 clause
7.5)

In this step whether the actions of risk control and/or risk reduction would introduce new
hazards or hazardous situations will be evaluated. In this case Step 3 has to be repeated.

Step 10: Completeness of Risk Control (According to ISO/TR 24971:2020 clause 7)

In this step, whether all relevant risks have been considered and whether the risk
evaluation process is complete will be checked. In case the risk evaluation is acknowledged
as complete.

Step 11: Evaluation of Overall Residual Risk Acceptability (According to ISO/TR

24971:2020 clause 8)

After the completion of all risk control measures, the whole residual risks as well as the
acceptability of the residual risks will be evaluated. The evaluation of the residual
risks will be performed analogically to the evaluation of the basic risks.

Step 12: Result of risk management (According to ISO/TR 24971: 2020 clause 9)

There will be a summarizing risk management report. It will summarize the risk
analysis, risk evaluation and management of preventive respectively risk control measures.
This risk management report will be set up and released at least once per year by the
management or its deputy.

Step 13: Production and post-production information (According to ISO/TR 24971: 2020
clause 10)

Production and after production information acquisition method to see the customer
information feedback control program, the board of the customer information
feedback control program production and after production information access the
suitability and effectiveness of the evaluation, think: this method is suitable and effective,
the production and after production information access can be according to the
requirements of the customer information feedback control program, the project risk
management, head to the production and after production information management,
when necessary, the risk management team to implement the dynamic risk management
activities.

This product has been sold for many years. Once the product occurs upgrade or instead
by new design, will be collected on various types of risk, and once again to analyze,
evaluate, control, update the content of risk management report.

To review all records of above implementing procedures, to evaluate the aroused risk if exist
and start a new round risk analysis and management.

According to the records of the above implementing procedures, no new risks aroused.
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Review of risk management experience:

As above, related members reviewed the risk management.

-Maker complaints or grievances

Please refer to file 07 – Post Market Surveillance.

Related records:

a) Customer feedback investigation (included in CER)

b) Sales information (included in CER)
c) Adverse event, recall, complaint, nonconformity (included in CER)

1.4 Risk Management Process

The risk management process will be conducted follow the process below and
company Risk Management procedure.
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Chapter Two Risk Analysis

2.1 Risk evaluation criteria

2.1.1 Risk severity level

Table 1 Severity Level

Grading Level Risk System Definition

1 Negligible
2 Minor
3 Serious
4 Critical
5 Catastrophic
Inconvenience or temporary discomfort
Results in temporary injury or impairment not
requiring professional medical intervention
Results in injury or impairment requiring
professional medical intervention
Results in permanent impairment or life-
threatening injury
Results in patient death

2.1.2 Risk Frequency Level

Risk management team shall analysis the hazard, on the perspective of loss probability and
severity, and record.

Table 2 Probability Level

Probability Level Risk System Definition

Grading
1 Improbable < 10-6
2 Remote < 10-5 and ≥ 10−6
3 Occasional < 10-4 and ≥ 10−5
4 Probable < 10-3 and ≥ 10−4
5 Frequent ≥ 10−3

2.1.3 Acceptance Criteria

Qualitative severity levels

Probability 1. Negligible 2. Minor 3. Serious 4. Critical 5. Catastrophic
5. Frequent NAC NAC NAC NAC NAC
4. Probable NAC NAC NAC NAC NAC
3. Occasional AC NAC NAC NAC NAC
2. Remote AC AC NAC NAC NAC
1. Improbable AC AC AC NAC NAC

NAC = unacceptable AC = acceptable

The estimated risk to each hazard/ reason is written list with the form of classification
(NAC/AC), give clear indication if it has control measures.

Identification of qualitative and quantitative characteristics (According to ISO/TR

24971:2020 Annex A)

Item Questions Answer/Comments

A.2.1 What is the intended use and how is the See Instruction for Use
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medical device to be used?

A.2.2 Is the medical device intended to be NO.
implanted?
A.2.3 Is the medical device intended to be in YES, contact the user directly
contact with the patient or other persons?
A.2.4 What materials or components are utilized Please refer to Device
in the medical device or are used with, or Description for material used.
are in contact with, the medical device? The main body of product will
contact with human skin.
A.2.5 Is energy delivered to or extracted from NO.
the patient?
A.2.6 Are substances delivered to or extracted NO.
from the patient?
A.2.7 Are biological materials processed by the NO.
medical device for subsequent re-use,
transfusion or transplantation?
A.2.8 Is the medical device supplied sterile or NO.
intended to be sterilized by the user, or are other
microbiological controls applicable?
A.2.9 Is the medical device intended to be YES, refer to IFU.
routinely cleaned and disinfected by the
user?
A.2.10 Does the medical device modify the NO.
patient environment?
A.2.11 Are measurements taken? NO.
A.2.12 Is the medical device interpretative? NO.
A.2.13 Is the medical device intended for use in NO.
conjunction with other medical devices,
medicines or other medical technologies?
A.2.14 Are there unwanted outputs of energy or NO.
substances?
A.2.15 Is the medical device susceptible to Refer to IFU
environmental influences?
A.2.16 Does the medical device influence the NO.
environment?
A.2.17 Does the medical device require NO.
consumables or accessories?
A.2.18 Is maintenance or calibration necessary? NO.
A.2.19 Does the medical device contain NO.
software?
A.2.20 Does the medical device allow access to NO.
information?
A.2.21 Does the medical device store data critical NO.
to patient care?
A.2.22 Does the medical device have a restricted Refer to IFU
shelf-life?
A.2.23 Are there any delayed or long-term use NO.
effects?
A.2.24 To what mechanical forces will the medical device be NO.
subjected?
A.2.25 What determines the lifetime of the medical device? Using and maintenance.
A.2.26 Is the medical device intended for single NO.
use?
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A.2.27 Is safe decommissioning or disposal of NO.

the medical device necessary?
A.2.28 Does installation or use of the medical device YES. Please refer to IFU for
require special training or special skills? installation and use.

A.2.29 How will information for safety be Instruction for Use.

provided?

A.2.30 Are new manufacturing processes NO.

established or introduced?

A.2.31 Is successful application of the medical NO.

device critically dependent on the usability
of the user interface?
A.2.31.1 Can the user interface design features contribute NO.
to use error?
A.2.31.2 Is the medical device used in an NO.
environment where distractions can cause
use error?
A.2.31.3 Does the medical device have connecting NO.
parts or accessories?
A.2.31.4 Does the medical device have a control NO.
interface?
A.2.31.5 Does the medical device display NO.
information?
A.2.31.6 Is the medical device controlled by a NO.
menu?
A.2.31.7 Is the successful use of the medical device dependent Yes. The device is easy to
on a user’s knowledge, skills and abilities? operate by user.
A.2.31.8 Will the medical device be used by NO.
persons with special needs?
A.2.31.9 Can the user interface be used to initiate NO.
unauthorized actions?
A.2.32 Does the medical device include an alarm NO.
system?
A.2.33 In what way(s) might the medical device NO.
be misused (deliberately or not)?
A.2.34 Is the medical device intended to be Yes. Portable
mobile or portable?
A.2.35 Does the use of the medical device The device is easy to operate.
depend on essential performance?
A.2.36 Does the medical device have a degree of NO.
autonomy?
A.2.37 Does the medical device produce an output NO.
that is used as an input in determining
clinical action?

Form 1. Risk Analysis, Control measurements and risk Evaluation after taking measures
(According to ISO/TR 24971:2020 Annex C, ISO/TR 24971:2020 clause 7.4,7.5,7.6)
Risk
N Hazard Risk Evaluation RRM Evidence NH RL
Evaluation
O Risk Reduction Measure
General Identify hazards S P RL S P RL
E.1 Energy hazards
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1 Line voltage N/A

2 Leakage current N/A
3 Electric fields N/A
4 Magnetic fields N/A
5 Ionizing radiation N/A
6 Non-ionizing N/A
radiation
7 High N/A
temperature
8 Low temperature N/A
9 Gravity falling N/A
10 Suspended N/A
masses
11 Vibration N/A
12 Stored energy N/A
13 Moving parts N/A
14 Torsion, shear N/A
and tensile force
15 Moving and N/A
positioning of
patient
16 Ultrasonic energy N/A
17 Infrasound N/A
energy
18 Sound N/A
19 High pressure N/A
fluid injection
E.2 Biological and Chemical Hazards
1 Bacteria Patient may 3 3 NAC 1. Indicate to users in 1. Instruction 3 2 AC H1 AC
have a bacterial the instruction manual Manual
infection if did how to use the product 2.Product
not use the and indicate the user Performance Test
product how to use the device Report
properly or properly 3.Biocompatibility
share the 2. Ensure product Compliance Evidence
device with quality by strictly follow
other patient the QMS
2 Viruses Patient may 3 3 NAC 1. Indicate to users in 1. Instruction 3 2 AC H2 AC
have a bacterial the instruction manual Manual
infection if did how to use the product 2.Product
not use the properly and the clean Performance Test
product methods. Report
properly or re- 2. Ensure product 3.Biocompatibility
use the product quality by strictly follow Compliance Evidence
without the the QMS
properly
cleaning
3 Other agents N/A
(e.g. prions)
4 Re- or cross- Patient may got 3 3 NAC Indicate to users in the Instruction manual 3 2 AC H3 AC
infection infection if the instruction manual does
product were not cross-used the
cross-used by product with other
other patient patient.
5 Acids or alkakis N/A
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6 Residues N/A
7 Contaminates The products 3 3 NAC Indicate to users in the Instruction manual 3 2 AC H4 AC
may be instruction manual how
contaminated if to use the product and
the package of indicate the user not to
device is use the product in the
damaged. package damaged.
8 Additives or N/A
processing aids
9 Cleaning, The products 3 3 NAC Indicate to users in the Instruction manual 3 2 AC H5 AC
disinfecting or may be instruction manual how
testing agent contaminated to clean the device
without using
properly
cleaning
method
10 Degradation N/A
products
11 Medical gasses N/A
12 Anesthetic N/A
products
13 Toxicity of N/A
chemical
constituents
14 Bio- The product 3 3 NAC Single use and raw Instruction manual 3 1 AC H6 AC
incompatibility may cause the material control and raw material
user inspection report.
uncomfortable
if the material
is not meet the
safety
requirements
15 Allergenicity The product 3 3 NAC Choose raw materials Biocompatibility 3 1 AC H7 AC
may cause the meeting the Compliance Evidence
user requirements
uncomfortable
if the material
is not meet the
safety
requirements
16 Irritancy The product 3 3 NAC Choose raw materials Biocompatibility 3 1 AC H8 AC
may cause the meeting the Compliance Evidence
user requirements
uncomfortable
if the material
is not meet the
safety
requirements
17 Pyrogenicity N/A
E.3 Environmental hazards and contributory factors
1 Electricity N/A
2 Pressure N/A
3 Radiation N/A
4 Volume N/A
5 Susceptibility to N/A
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electromagnetic
interference
6 Emissions of N/A
electromagnetic
interference
7 Inadequate N/A
supply of power
8 Inadequate N/A
supply of coolant
9 Storage or The product 3 2 NAC 1. Indicate the IFU: Warehouse 3 1 AC H9 AC
operation cannot reach distributor or use to management practices
outside the intended store the product by
prescribed use if not strictly follow the user
environmental properly stored manual.
conditions that the cause 2. Control storage /
the product operation process
damaged
10 Incompatibility N/A
with other
devices
11 Accidental N/A
mechanical
damage
12 Corrosions N/A
13 Degradation N/A
14 Contamination N/A
E.4. Hazards related to the use of the device and contributory factors
1 Inadequate Inadequate 3 2 NAC Design the label to Label 3 1 AC H10 AC
labelling labeling may ensure label information
lead to complies with the
improper requirements of the
operation of General Safety and
the user during Performance
use, and cause Requirements.
abnormal
functions of the
device and
cause damage.
2 Inadequate Incomplete 3 2 NAC Write the instruction for Instruction for Use 2 2 AC H11 AC
operating information in Use to comply with the
instructions the instruction requirements of the
for use, such as General Safety and
insufficient Performance
precaution of Requirements.
safe use, too
complicated
operating
instructions,
unreasonable
recommended
maintenance
methods may
lead to
improper
operation of
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the user during

use and cause
abnormal
functions of the
device and
cause damage.
3 Use by N/A
unskilled/untrain
ed personnel
4 Reasonably Mistakenly 3 3 NAC Design the label with Label 3 1 AC H12 AC
foreseeable operation may warning information to
misuse cause ensure label information
unexpected use comply with the
of the device requirements of the
that cause General Safety and
harm to patient Performance
Requirements.
5 Insufficient N/A
warning of side
effects
6 Inadequate Reuse of the 3 3 NAC Design the label with Label 3 1 AC H13 AC
warning of device may warning information to
hazards likely cause harm to ensure label information
with re-use of patient. comply with the
single use requirements of the
devices. General Safety and
Performance
Requirements.
7 Incorrect N/A
measurement
and other
metrological
aspects
8 Incompatibility N/A
with
consumables/
accessories/other
devices
9 Sharp edges or N/A
points
E.5 Inappropriate, inadequate or over-complicated user interface (man/machine communication)
1 Mistakes and N/A
judgment errors
2 Lapses and N/A
cognitive recall
errors
3 Attentional N/A
failure
4 Violation or N/A
abbreviation of
instructions,
procedures, etc.
5 Complex or N/A
confusing control
system
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6 Ambiguous or N/A
unclear device
state
7 Ambiguous or N/A
unclear
presentation of
settings,
measurements or
other
information
8 Mispresentation N/A
of results
9 Insufficient N/A
visibility,
audibility or
tactility
10 Poor mapping of N/A
controls to
action, or of
displayed
information to
actual state
11 Controversial N/A
modes or
mappings as
compared to
existing
equipment
E.6. Hazards arising from functional failure, maintenance and ageing
1 Erroneous data N/A
transfer
2 Lack of , or The device may 2 3 NAC 1. Indicate the use Instruction for Use 2 2 AC H14 AC
inadequate not work well if instructions in the user
specification for lack of manual.
maintenance adequate
including functional
inadequate checks before
specification of use
post
maintenance
functional checks
3 Inadequate N/A
maintenance
4 Lack of adequate N/A
determination of
end of device life
5 Loss of N/A
electrical /
mechanical
integrity
6 Inadequate The device may 2 3 NAC 1. Package the product 1.Product release 2 2 AC H15 AC
packaging be by strictly follow the inspection records
(contamination contaminated if QMS 2. Instruction for Use
and / or the product 2. Indicate the user do
deterioration of package is not use the product if
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the device) damaged. the package damaged.

7 Re-use and / or N/A
improrer re-use
8 Deterioration in N/A
function (e.g.
gradual occlusion
of fluid/gas path,
or change in
resistance to
flow, electrical
conductivity) as a
result of
repeated use.
E.7 Production and post-production information Foresee
1 Inadequate of N/A
designing
parameters
2 Inadequate of N/A
operating
parameters
3 Inadequate of A product 3 2 NAC Package the product by Factory inspection 3 1 AC H16 AC
performance quality will be strictly follow the QMS records
requirements affected Product Performance
Test Report
4 Insufficient A product 3 2 NAC Control the Quality Procedure 3 1 AC H17 AC
control of quality will be manufacturing
changes to affected processes by strictly
manufacturing follow the QMS
processes
5 Insufficient A product 3 2 NAC Chose the material 1. Biocompatibility 3 1 AC H18 AC
control of quality will be which meet the Compliance Evidence
materials/materi affected or hurt requirement 2. Incoming material
als compatibility patient Inspection report
processes
6 Insufficient A product 3 2 NAC Control the Quality Procedure 3 1 AC H19 AC
control of quality will be manufacturing
manufacturing affected processes by strictly
processes follow the QMS
7 Insufficient A product 3 2 NAC Chose the material 1. Biocompatibility 3 1 AC H20 AC
control of quality will be which meet the Compliance Evidence
subcontractors affected or hurt requirement 2. Incoming material
patient Inspection report
8 Lack of, or N/A
inadequate
specification for,
validated
procedures for
cleaning,
disinfection and
sterilization
9 Inadequate N/A
conduct of
cleaning,
disinfection and
sterilization
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10 Inadequate A the product 3 2 NAC Collect post-product Quality Procedure 2 2 AC H21 AC

collection post- did not satisfy information according
product the customer to QMS
information or could not
meet the
requirement

Form 2. Residual risk analysis

(According to ISO/TR 24971Q2020 clause 8)
Whether
Whether there is no Whether Risk
Whether Whether the the
further reduction in Reduction Whether Whether the
Hazard adopting clinical benefits measures of
SN. technology (Economic implements the it meets residual risk is
code the latest greater than reducing
factors are not taken regulation “As far MDR ER acceptable
technology risk risk create
into account as possible”
new risks
1 H1 Yes yes yes yes yes yes NO
2 H2 Yes yes yes yes yes yes NO
3 H3 Yes yes yes yes yes yes NO
4 H4 Yes yes yes yes yes yes NO
5 H5 Yes yes yes yes yes yes NO
6 H6 Yes yes yes yes yes yes NO
7 H7 Yes yes yes yes yes yes NO
8 H8 Yes yes yes yes yes yes NO
9 H9 Yes yes yes yes yes yes NO
10 H10 Yes yes yes yes yes yes NO
11 H11 Yes yes yes yes yes yes NO
12 H12 Yes yes yes yes yes yes NO
13 H13 Yes yes yes yes yes yes NO
14 H14 Yes yes yes yes yes yes NO
15 H15 Yes yes yes yes yes yes NO
16 H16 Yes yes yes yes yes yes NO
17 H17 Yes yes yes yes yes yes NO
18 H18 Yes yes yes yes yes yes NO
19 H19 Yes yes yes yes yes yes NO
20 H20 Yes yes yes yes yes yes NO
21 H21 Yes yes yes yes yes yes NO
Conclusion:

All risks associated with the identified hazards have been evaluated considering EN
ISO14971.The overall level of risk of the product is acceptable. After appropriate measures
to reduce these risks have been taken, the overall risks (all risks together) have been
deemed acceptable versus the benefit of the device.
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6.1 Clinical Evaluation Report

File No.: CE

Version: A/0

Product: Hip orthosis/ Knee orthosis/ Knee/ ankle/ foot orthosis

Prepared by Reviewed by Approved by

Name Name Name
Position Position Position
Signature Signature Signature
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Table of Contents
Executive summary....................................................................................................................6
1. Scope of the clinical evaluation…………………………………………………………………………………………6
2. Device description…………………………………………………………………………………………………………….7
3. Clinical background, current knowledge, state of the art………………………………………………….7
4. Identification of relevant clinical data……………………………………………………………………………….8
4.1. Literature Data…………………………………………………………………………………………………..8
4.2 PMS data generated and held by Manufacture………………………………………………....8
4.3 PMS data of similar device......................................................................................8
4.4 Literature search plan.............................................................................................8
5. Analysis of Clinical Data.........................................................................................................9
5.1 Analysis of Literature..............................................................................................9
5.2 Analysis of Post-Marketing Data..........................................................................15
6. Next Clinical Evaluation.......................................................................................................16
7. Declaration of interests.......................................................................................................17
8. Reference.............................................................................................................................17
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Executive summary
This clinical evaluation report presents the clinical evaluation of Lower Limb Brace which
is intended to provide support, immobilizer, stabilizer or compression to lower limb,
including knee, calf, ankle etc. through providing compressive forces and traction in a
controlled manner, protecting the impaired joint or body part, stabilizing unstable bony
components and promoting healing of soft tissues and bones. The device is generally
used in orthopedics departments. It is re-usable.

The Lower Limb Brace is manufactured based on the quality management system ISO
13485:2016.

The clinical evaluation is conducted by collecting and analyzing clinical literature of the
similar device of Lower Limb Brace search from PubMed, ScienceDirect and other literature
database list in section 4.4.1. PMS data held by manufacture and PMS data of the similar
device from FDA Manufacturer and User Facility Device Experience (MAUDE) database.

The clinical data analysis concludes that the Lower Limb Brace complication rates and risks
related to the devices remain continuously low and acceptable. No clinically relevant change
is detected over time, and no new health or safety risks, no new side effects have been
discovered during this evaluation. Anticipated residual risks may occur, but the number is
low.

As a result of this clinical evaluation, the evidence provided demonstrates the safety and
performance of Lower Limb Brace in their product-specific indications as describable in
Instructions for Use, also conformity with the EU General Safety and Performance
Requirements.

1. Scope of the clinical evaluation

The objective of this clinical evaluation is to identify, select, review and assess all
available clinically relevant data of Lower Limb Brace.

Conformity assessment with the Medical Devices Regulation (EU) 2017/745 requires a
medical device manufacturer to demonstrate that the claims made in relation to the
device’s safety and performance, under the normal conditions of its use, are attainable.
Generally, this requires clinical data, but evidence of the satisfactory clinical safety and
performance of a device may be provided in the form of a critical evaluation of published
and/or unpublished data on clinical experience with the device, or on a similar device to
which equivalence can be demonstrated. This clinical evaluation is submitted to the MDR
(EU) 2017/745.

Based on the General Safety and Performance Requirements and the residual risk
findings from the Lower Limb Brace risk analysis, the scope of this clinical evaluation
comes from the intended performance and clinical residual risks in the risk analysis of these
products.

2. Device Description

Device Introduction
Please refer to Chapter 1 Section 1.1 about detailed device descrition.

Harmonized standards
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- Applicable Standard
Please refer to Chapter 1 Section 1.1 about applicable standard.

- Reference Guidance
Table 1. Reference Guidance

Item. Guidance Title

1 MEDDEV 2.7.1 rev.4 Clinical evaluation: A guide for manufacturers
(2016) and notified bodies under directives 93/42/EEC
and 90/385/EEC
2 MEDDEV 2.12-2 rev 2 Guidelines on post market clinical follow up
(2012)
3 GHTF SG5/N2R8 Clinical Evaluation

3. Clinical background, current knowledge, state of the art

Lower limb orthoses are used in individuals with a wide range of conditions resulting in
impaired functional mobility and loss of independence. These devices are most commonly
utilized to enhance stability in both standing and walking when lower extremity weakness is
present, but may also be indicated when correction of a lower limb deformity is the desired
outcome. Lower limb orthoses can also be used in order to stabilize a joint in the setting of
ligamentous deficiency as well as provide pain relief in the setting of joint deterioration.
Lower limb orthoses encompass a broad spectrum of devices ranging from simple and
inexpensive devices such as a knee sleeve or accommodative foot orthotic to sophisticated
and expensive devices such as a computerized knee-ankle-foot orthosis. Significant
advances have occurred in the materials and fabrication techniques used for lower limb
orthoses allowing braces to be both more lightweight and durable. Orthoses incorporating
microprocessor joint control are available, and it is anticipated that further advances will
continue in the future. Despite these technology advances and the wide variety of available
lower limb orthoses, clinical decision-making remains challenging because of the lack of
comparative effectiveness research to guide orthosis selection.

Lower limb orthoses serve multiple purposes, such as reducing pain in arthritic joints,
improving gait, and controlling abnormal movements. They can be composed of a variety of
materials such as plastics, metal, and leather. They may or may not have joints to surround
and support anatomic joints such as ankles and knees.

4. Identification of relevant clinical data

There are several types of clinical data which are clinical literature of similar device, PMS
data of the propose device from manufacture including sales and complaints data,
customer feedback, adverse event reports, the medical device reporting data and recall
data of similar device of similar device.

4.1. Literature Data

Literature from some databases is used to evaluate the safety and performance of
the predicate or similar device which are placed to the market.

4.2 PMS data generated and held by Manufacture

The propose device Lower Limb Brace has been sold for many years. PMS data
including customer feedback, customer complain, adverse event, recall and corrective
actions are used in this evaluation.
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4.3 PMS data of similar device

The device Lower Limb Brace has been widely used in the world; we will search the
adverse event, recall, corrective action of the similar device for a reference for the clinical
safety of the proposed device.

4.4 Literature search plan

4.4. 1 Literature search database

The databases used for literature search are shown as below:
 PubMed
 ScienceDirect

The keyword “lower limb orthosis” is used to search on the database list above and select
the relevant literature for clinical evaluation.

4.4.2 Literature selection criteria

The literature selection criteria process is as follow:

We select the relevant literature according to the device discussed in the article, if the
device is similar to the propose device, we will choose that literature for evaluation. If
the device has similar intended use, the same work mechanism to the propose device,
the device will be deemed as the similar device.

4.4.3 Literature exclusion criteria

We will review all articles’ title and/or abstracts, if the article do not include lower limb
orthosis or the article in question did not examine humans; or no clinical data was
available. The article would be excluded. Besides, we will review all the titles and
abstracts of all the relevant literature to exclude the same literature.

5. Analysis of Clinical Data

5.1 Analysis of Literature
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The key word “lower limb orthosis” is used to search relevant literatures in the database
listed in section 4.4.1 and search time is from 2000 to 2021. Take the PubMed database for
example, when we enter key word “lower limb orthosis”, 452 literatures are found in
PubMed, then we review the relevance of literature and download 11 relevant literatures
for review and completely review the literature, finally 3 literatures are chosen for
evaluation. The search result is as below.

Figure 1. Search Result in PubMed

The relevant literatures and the literatures used for clinical evaluation of all the databases
we searched are shown in table below.

Table 3 Literature Collection in different Database

Item Database Search Search Term Search Total Relevant Literature

Time Period Literature Literature for Clinical
Evaluation
1 PubMed 2021 Lower limb 2000- 452 11 3
orthosis 2021
2 Science 2021 2000- 123 15 2
Direct 2021

Base on the Literature search result above, there are 5 literatures used in this
clinical evaluation. Literature analysis is shown in the table below.

Table 4 Literature Analysis

Item Literature Author / Abstract

Publication
1 Quantifying AmirALi Introduction: Flat feet in children negatively affect lower
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lower limb Jafarnezhadgero, limb alignment and cause adverse health-related

inter-joint Seyed Hamed problems. The long-term application of foot orthoses (FOs)
coordination Mousavi, Morteza may have the potential to improve lower limb coordination
and Madadi-Shad, and its variability.
coordination Juha M Hijmans Aim: To evaluate the effects of long-term use of arch
variability after support FOs on inter-joint coordination and coordination
four-month variability in children with flexible flat feet.
wearing arch Hum Mov Sci Methods: Thirty boys with flexible flat feet were randomly
support foot . 2020 assigned to the experimental (EG) and control groups. The
orthoses in Apr;70Q102593. EG used medial arch support FOs during daily activities
children with doiQ over a four-month period while the control group received
flexible flat feet 10.1016/j.humov. a flat 2-mm-thick insole for the same time period. Lower-
2020.102593. limb coordination and variability during the 3 sub-stance
Epub 2020 Feb phases were quantified using a vector coding technique.
28. Results: Frontal plane ankle-hip coordination in EG during
mid-stance changed to an anti-phase pattern (156.9°) in
the post-test compared to an in-phase (221.1°) in the pre-
test of EG and post-test of CG (222.7). Frontal plane knee-
hip coordination in EG during loading response (LR)
changed to an anti-phase pattern (116°) in the post-test
compared to an in-phase (35.5°) in the pre-test of EG and
post-test of CG (35.3). Ankle inversion/eversion-knee
internal/external rotation joint coupling angle in EG
changed to an in-phase pattern (59°) in the post-test
compared to a proximal phase (89°) in the pre-test.
Coupling angle variability increased in the post-test of EG
for sagittal plane ankle-hip during push-off, transverse
plane ankle-hip during LR and mid-stance, and transverse
plane knee-hip during LR and mid-stance compared to
pre-test of EG and post-test of CG.
Conclusion: The long-term use of arch support FOs proved
to be effective to alter lower limb coordination and
coordination variability during walking in children with
flexible flat feet. This new insight into coordinative
function may be useful for improving corrective exercise
strategies planned for children with flat feet.
Keywords: Coupling angle; Insole; Long-term wearing; Pes
planus; Pronation
2 Four-Week M Spencer Cain, Context: Researchers have shown that rehabilitation
Ankle- Rebecca J Ban, programs incorporating resistance-band and balance-
Rehabilitation Yu-Ping Chen, board exercises are effective for improving clinical
Programs in Mark D Geil, measures of function and patient-reported outcomes in
Adolescent Benjamin M individuals with chronic ankle instability (CAI). However,
Athletes with Goerger, Shelley whether combining the 2 exercises increasing
chronic Ankle W Linens improvement is unknown.
Instability Objective: To determine the effectiveness of 3
J Athl Train, 2020 rehabilitation programs on clinical measures of balance
Aug and self-reported function in adolescent patients with CAI.
1;55(8)Q801-810. Design: Randomized controlled clinical trial (Trail
doi: Registration Number: ClinicalTrails.gov: NCT03447652).
10.4085/1062- Setting: High school athletic training facilities.
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6050-41-19. Patients or other participants: Forty-three patients with

CAI (age = 16.37 ± 1.00 years, height = 171.75 ± 12.05 cm,
mass = 69.38 ± 18.36 kg) were block randomized into 4
rehabilitations groups.
Intervention(s): Protocols were completed 3 times per
week for 4 weeks. The resistance-band group performed 3
sets of 10 repetitions of ankle plantar flexion, dorsiflexion,
inversion, and eversion with a resistance band. The
Biomechanical Ankle Platform System group performed 5
trials of clockwise and counterclockwise rotations,
changing direction every 10 seconds during each 40-
second trial. The combination groups completed
resistance-band and Biomechanical Ankle Platform System
programs during each session. The control group did not
perform any exercises.
Main outcome measure(s): Variables were assessed
before and after the intervention: time-in-balance test,
foot-lift test, Star Excursion Balance Test, side-hop test,
figure-8 hop test, Foot and Ankle Ability Measure, and
Cumberland Ankle Instability Tool. We conducted 4
separate multivariate repeated-measures analyses of
variance, followed by univariate analyses for any findings
that were different.
Results: Using the time-in-balance test, foot-lift test, Star
Excursion Balance Test (medial, posteromedial, and
posterolateral directions), and figure-8 hop test, we
detected improvement for each rehabilitation group
compared with the control group (P < .05). However, no
intervention group was superior.
Conclusions: All 3 rehabilitation groups demonstrated
improvement compared with the control group, yet the
evidence was too limited to support a superior
intervention. Over a 4-week period, either of the single-
task interventions or the combination intervention can be
used to combat the residual deficits associated with CAI in
an adolescent patient population.
Keywords: dynamic balance; functional performance;
patient-reported outcomes; static balance.

3 Effectiveness of Daniel R Objectives: To evaluate the effectiveness of prefabricated

foot orthoses Bonanno, George foot orthoses for the prevention of lower limb overuse
for the S Murley, injuries in naval recruits.
prevention of Shannon E Methods: This study was a participant-blinded and
lower limb Munteany, Karl B assessor-blinded, parallel-group randomized controlled
overuse injuries Landorf, Hylton Btrial. Three-hundred and six participants aged 17-50 years
in naval Menz who undertook 11 weeks of initial defense training at the
recruits: a Royal Australian Navy Recruit School (Cerberus, Australia)
randomized Br J Sports Med. were randomized to a control group (flat insoles, n+153) or
controlled trial 2018 an intervention group (contoured, prefabricated foot
Mar;52(5)Q298-3- orthoses, n=153). The combined incidence of medial tibial
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02. doi: stress syndrome, patellofemoral pain, Achilles

10.1136/bjsports- tendinopathy and plantar fasciitis/plantar heel pain during
2017-098273. the 11-week training period was compared using incidence
Epub 2017 Oct rate ratios (IRR). Data were analyzed using the intention-
22. to-treat principle.
Results: Sixty-seven injuries (21.9%) were recorded. The
control and intervention group sustained 40 (26.1%) and
27 (17.6%) injuries, respectively (IRR 0.66 95% Cl 0.39 to
1.11, p=0.098). This corresponds to a 34% reduction in risk
of developing medial tibial stress syndrome, patellofemoral
pain, Achilles tendinopathy or plantar fasciitis/plantar heel
for the intervention group compared with the control
group. Participants in the prefabricated orthoses group
were more likely to report at least one adverse event
(20.3% vs 12.4%; relative risk (RR) 1.63, 95% CI 0.96 to
2.76; p=0.068; number needed to harm 13, 95% CI 6 to
253). The most common adverse events were foot blisters
(n=20, 6.6%), arch pain (n=10, 3.3%) and shin pain (n=8,
2.6%).
Conclusion: Prefabricated foot orthoses may be beneficial
for reducing the incidence of lower limb injury in naval
recruits undertaking defense training.
Trial registration number: Australian New Zealand Clinical
Trials Registry: ACTRN12615000024549.
Keywords: foot injuries; injury prevention; lower limb;
orthotics; overuse injury.
4 Immediate Myoung Kwon Abstract
Effects of Ankle Kim, Young Jun BACKGROUND The objective of this study was to
Balance Taping Shin investigate the immediate effect on gait function when
with ankle balance taping is applied to amateur soccer players
Kinesiology Med Sci Monit. with lateral ankle sprain. MATERIAL AND METHODS A
Tape for 2017 Nov cross-over randomized design was used. Twenty-two
Amateur Soccer 21;23:5534-5541. soccer players with an ankle sprain underwent 3
Players with doiQ interventions in a random order. Subjects were randomly
Lateral Ankle 10.12659/msm.9 assigned to ankle balance taping, placebo taping, and no
Sprain: A 05385. taping groups. The assessment was performed using the
randomized GAITRite portable walkway system, which records the
Cross-Over location and timing of each footfall during ambulation.
Design RESULTS Significant differences were found in the velocity,
step length, stride length, and H-H base support among the
3 different taping methods (p<0.05). The ankle balance
taping group showed significantly greater velocity, step
length, and stride length in comparison to the placebo and
no taping group. The ankle balance taping group showed a
statistically significant decrease (p<0.05) in the H-H base
support compared to the placebo and no taping groups,
and the placebo group showed significantly greater
velocity in comparison to the no taping group (p<0.05).
CONCLUSIONS
We conclude that ankle balance taping that uses
kinesiology tape instantly increased the walking ability of
amateur soccer players with lateral ankle sprain.
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Therefore, ankle balance taping is a useful alternative to

prevent and treat ankle sprain of soccer players.
5 The long term AmirAli Abstract
use of foot Jafarnezhadgero, Background: Due to inclusive evidence on the effects of
orthoses affects Morteza Madadi- foot orthoses treatment on lower limb kinematics and
walking Shad, Seyed kinetics in children, studies are needed that particularly
kinematics and Majid Alavi-Mahr, evaluate the long-term use of foot orthoses on lower limb
kinetics of Uhr Granacher alignment during walking. Thus, the main objective of this
children with study was to evaluate the effects of long-term treatment
flexible flat PloS One. 2018 with arch support foot orthoses versus a sham condition
feet: A Oct on lower extremity kinematics and kinetics during walking
randomized 9;13(10):e020518 in children with flexible flat feet.
controlled trial 7. Methods: Thirty boys aged 8-12 years with flexible flat feet
doi: participated in this study. While the experimental group (n
10.1371/journal.p = 15) used medial arch support foot orthoses during
one.0205187.eCol everyday activities over a period of four months, the
lection2018. control group (n = 15) received flat 2-mm-thick insoles (i.e.,
sham condition) for the same time period. Before and after
the intervention period, walking kinematics and ground
reaction forces were collected.
Results: Significant group by time interactions were
observed during walking at preferred gait speed for
maximum ankle eversion, maximum ankle internal rotation
angle, minimum knee abduction angle, maximum knee
abduction angle, maximum knee external rotation angle,
maximum knee internal rotation angle, maximum hip
extension angle, and maximum hip external rotation angle
in favor of the foot orthoses group. In addition, statistically
significant group by time interactions were detected for
maximum posterior, and vertical ground reaction forces in
favor of the foot orthoses group.
Conclusions: The long-term use of arch support foot
orthoses proved to be feasible and effective in boys with
flexible flat feet to improve lower limb alignment during
walking.

5.2 Analysis of Post-Marketing Data

The Lower Limb Brace has been put on market for many years and the use of Lower Limb
Brace is mature. The actual sales quantity and the feedback may be found in clause 7.2.1 of
the technical files.

The manufacture has established quality management system and strictly follow the work
instructions to ensure the product quality. And the Lower Limb Brace has been placed on
market for several years and a large number of devices has been sold. The PMS data shows
the Lower Limb Brace is safely used on the market. The PMS data including customer
feedback, customer complain are continuously collect to monitor the safety and
effectiveness of Lower Limb Brace.
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Literature, the safety tests, biocompatibility tests and General Safety and Performance
Requirement demonstrate that the propose device is safe and effectiveness. The risk about
propose device has been identified and mitigated to be acceptable or as low as reasonable
practice.

Base on the evaluation of clinical literature, PMS data of the propose device, PMS data of
similar device, General Safety and Performance Requirement, risk analysis of propose
device. The overall clinical risk of the propose device Lower Limb Brace is low and
acceptable. This clinical evaluation is complied with MDR (EU) 2017/745.

6. Next Clinical Evaluation

As extensively outlined above, the use of Lower Limb Brace is well-established and the safety
profile is well-known without significant risks. Safety and performance of this product has
been examined and documented in many clinical studies. Moreover, extensive experience in
clinical practice and post-marketing data support the performance and safety profile of
Lower Limb Brace in the claimed indications.

The clinical evaluation will be updated once per three years normally, but should be updated
immediately if significant risk were found.

7. Declaration of interests

Sun, Tina, Raymond, are hired by the manufacturer concerned as clinical evaluator of Lower
Limb Brace to participate in the clinical evaluation. In order to ensure the validity and
impartiality of clinical evaluation. We make a declaration of interests as follow.

 The clinical evaluation does not involve any financial interests of ourselves;
 The clinical evaluation does not involve any financial interests of our family members;
 The clinical evaluation does not involve any ownership/ shareholding possibly affected
by the outcome of the evaluation;
 The clinical evaluation does not involve any grants sponsored by the manufacturer;
 The clinical evaluation does not involve any benefits such as travelling or hospitality;
 The clinical evaluation does not involve any interests in connection with
intellectual property, such as patents, copyrights and royalties possibly affected by the
outcome of the evaluation;

8. Reference

1. Jafarnezhadgero, AmirAli; Mousavi, Seyed Hamed; Madadi-Shad, Morteza;

Hijmans, Juha M (2020). Quantifying lower limb inter-joint coordination and
coordination variability after four-month wearing arch support foot orthoses in
children with flexible flat feet. Human Movement Science, 70(), 102593–.
doi:10.1016/j.humov.2020.102593
2. M Spencer Cain, Rebecca J Ban, Yu-Ping Chen, Mark D Geil, Benjamin M Goerger,
Shelley W Linens, Four-Week Ankle-Rehabilitation Programs in Adolescent
Athletes With Chronic Ankle Instability, J Athl Train. 2020 Aug 1;55(8):801-810.,
doi: 10.4085/1062-6050-41-19.
3. Daniel R Bonanno, George S Murley, Shannon E Munteanu, Karl B Landorf, Hylton
B Menz, Effectiveness of foot orthoses for the prevention of lower limb overuse
injuries in naval recruits: a randomised controlled trial, Br J Sports Med,. 2018
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Mar;52(5):298-302, doi: 10.1136/bjsports-2017-098273. Epub 2017 Oct 22.

4. Myoung Kwon Kim, Young Jun Shin, Immediate Effects of Ankle Balance Taping
with Kinesiology Tape for Amateur Soccer Players with Lateral Ankle Sprain: A
Randomized Cross-OverDesign, Med Sci Monit. 2017 Nov 21;23:5534-5541. doi:
10.12659/msm.905385.
5. AmirAli Jafarnezhadgero,Morteza Madadi-Shad, Seyed Majid Alavi-Mehr,Urs
Granacher, The long-term use of foot orthoses affects walking kinematics and
kinetics of children with flexible flat feet: A randomized controlled trial, PLoS One.
2018 Oct 9;13(10):e0205187. doi: 10.1371/journal.pone.0205187. eCollection
2018.
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6.3 Biocompatibility Compliance Evidence

File No.: CE

Version: A/0

Product: Hip orthosis/Knee orthosis/Knee/ankle/foot orthosis

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1. Foreword

This report is to describe the biological risk control carried on the common raw materials
used for manufacturing medical device in contact with human skin. All potential biological
hazards and potential cause of each hazard have been determined in this report. Evaluations
have been made on possible severity level may led by each hazard and probability of
occurrence of each hazard. For unacceptable risks, necessary measures must be taken, and
also evaluate the residual risk level after taking relevant measures.

To reduce the risks which may lead to various kinds of potential hazards to the acceptable
level and to reduce the total amount of every kind of hazards to the acceptable level by
taking proper measures.

2. Purpose

Aim of this risk control is to carry out determination on the biological risks that may be led
by the he common raw materials used for manufacturing medical device, also to stipulate
the necessary relative measures, in order to keep the risk level within an acceptable level.

By taking risk control the company may take relative measures of continuously improving
quality of the products, to meet customer stipulated or potential requirements constantly.

3. Documents reference

EN ISO14971:2019, Medical devices - Application of risk management to medical devices

ISO10993-1:2018 Biological evaluation of medical devices—Part 1: Evaluation and testing

within a risk management process

4. Categorization of raw materials used for manufacturing medical device

These include the materials used for manufacturing medical devices in contact with persons
as the following:
 Neoprene (polychloroprene (PCP) )
 Cotton

Table 1. Raw Material Properties

Material Physical Property Chemical Property
Neoprene Neoprene (also polychloroprene) is a family of
(polychloroprene synthetic rubbers that are produced by
(PCP) )
polymerization of chloroprene. Neoprene
exhibits good chemical stability and maintains
flexibility over a wide temperature range.
Neoprene is sold either as solid rubber or in
latex form and is used in a wide variety of
applications, such as laptop sleeves,
orthopedic braces (wrist, knee, etc.), electrical
insulation, liquid and sheet-applied
elastomeric
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membranes or flashings, and automotive fan

belts.

Cotton Shape: Fairly uniform in width, 12-20 Cotton is nature substance the
micrometers; length varies for 1 cm to 6 cm chemical composition of cotton
(1/2 to 2 ½ inches); is as follows:
Typical length is 2.2 cm to 3.3 cm (7/8 to 1 ¼ cellulose 91.00%
inches).
Tenacity (strength) water 7.85%
Dry: 3.0-5.0 g/d protoplasm, pectin’s 0.55%
Wet: 3.3-6.0 g/d waxes, fatty substances 0.40%
Resiliency: low mineral salts 0.20%
Density: 1.54-1.56 g/cm3
Dimensional stability: good
Resistance to acids: damage, weaken fibers
Alkali: resistant; no harmful effects
Organic solvents: high resistance to most
Sunlight: prolonged exposure weakens fibers.
Microorganisms: Mildew and reproducing
bacteria damage fibers.
Insects: Silverfish damage fibers.

Table 2. Literature search

Literature (Neoprene Abstract Conclusion

polychloroprene (PCP) )
Title ： Strain-induced
crystallization in a carbon-black
filled polychloroprenerubber:
Kinetics and mechanical
Cycling
Publisher ： PolymerVolume
17331 May 2019 Pages 158-
165
Author： Pierre-Yves Le Gac,
Pierre-Antoine Albouy, Paul
Sotta
It is shown in the present •The effect of filler addition
paper how the addition of a οn SIC in polychloroprene
moderate amount of carbon rubber is investigated.
black filler to a •Strain and stress
polychloroprene gum
amplification effects linked to
modifies the local strain state filler addition in absence of
and alters the ability of the
SIC are quantified.
polymer to strain-crystallize.
The study combines
•SIC-related stress hardening
mechanical and X-ray during tensile test appears
diffraction performed during
amplified by the presence of
classical mechanical cycling the filler.
and tensile impact tests. It
highlights the fact that the
strain modification induced by •SIC follows a logarithmic
the filler addition is highly time - dependence and
inhomogeneous: the develops at shorter times
crystallization behavior and
the local draw ratio state is compared to the unfilled case.
affected differently. The
partial relaxation of the
amorphous fraction by the
strain-induced crystallization
evidenced in the pure gum is
still present and should play a
protective role. The effect of
temperature on the
crystallization correlates with
the evolution of stress-strain
curves. In particular the role
of crystallization in stress
hardening is apparently
amplified by the presence of
the filler. Preliminary tensile
tests reveal a drastic decrease
of the induction time

Technical File
Title ： Reinforcement of
polychloroprene by grafted
silica nanoparticles
Publisher ： Polymer
Degradation and Stability
Volume 15
9 January 2019Pages 90-97
Author： Bidur Rijal,
Florian Klipfel, Isabelle Dez,
Jean Colin, Loïc Le Pluart
Literature (Cotton)
Hydrogen Peroxide
Generation of
Copper/Ascorbate
Formulations on
Cotton: Effect on
Antibacterial and
Fibroblast Activity for
Wound Healing
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necessary for crystallization to
develop. This implies a strain
amplification effect higher
than predicted from
mechanical cycling analysis. It
is proposed that carbon black
particles have no time to relax
during the fast-stretching
period. All these observations
point to a synergistic effect
between filler addition and
strain-induced crystallization.
Polychloroprene (PCP) and •Chlorosulfonated
chlorosulfonated polyethylene polyethylene (CSM)
(CSM) rubbers undergo a desulfonation proceeds at
multiple step degradation lower temperature than
pathway involving a common dehydrochlorination.
dehydrochlorination step •Using bismuth oxide (Bi2O3)
which causes HCl release from as radioprotective filler is
the macromolecules as detrimental to CSM and
evidenced by polychloroprene thermal
thermogravimetric analyses stability.
associated with operando
FTIR •Bismuth oxide promotes
analyses. Dehydrochlorination dehydrochlorination reaction
is detected at lower of chlorinated rubbers.
temperatures for CSM than
for PCP. It is preceded by non- •Transition metal oxides
simultaneous and very (La2O3, WO3) do not modify
distinctive desulfonation rubbers thermal stability.
reaction at even lower
temperatures as shown by
chemical analyses of the
evolved phase during a
thermal treatment.
Incorporation of Bi2O3, La2O3
and WO3 as potential fillers
for lead-free radioprotective
materials leads to diverse
effect on the thermal stability
of these rubbers. Whereas
transition metal oxides do not
affect the degradation
mechanisms, bismuth oxide
strongly promotes the
dehydrochlorination reaction
leading to a decrease of the
rubbers thermal stability
which is detrimental to the
potential processability and
recyclability of these
materials.
Abstract Conclusion
Greige cotton (unbleached This study examines the
cotton) is an intact plant fiber relative roles of copper and
that retains much of the outer ascorbate to produce
cotton fiber layers. These hydrogen peroxide when
layers contain pectin, attached to greige cotton for
peroxidases, and trace metals wound healing and
that are associated with antimicrobial applications and
hydrogen peroxide (H₂O₂) evaluates the sustained
generation during cotton fiber release of hydrogen
development. When greige peroxide production in a
cotton is subjected to a range associated with
 Doc. No.
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Application nonwoven
hydroentanglement process,
components of the outer
cotton fiber layers are
retained. When hydrated, this
fabric can generate H₂O₂ (5 ⁻
50 micromolar). This range
has been characterized as
inducing accelerated wound
healing associated with
enhanced cell signaling and
the proliferation of cells vital
to wound restoration. On the
other hand, H₂O₂ levels above
50 micromolar have been
associated with bacteriostatic
activity. Here, we report the
preparation and hydrogen
peroxide activity of
copper/ascorbate
formulations, both as
adsorbed and in situ
synthesized analogs on
cotton. The cooper/ascorbate-
cotton formulations were
designed with the goal of
modulating hydrogen
peroxide levels within
functional ranges beneficial to
wound healing. The
cotton/copper formulation
analogs were prepared on
nonwoven unbleached cotton
and characterized with cotton
impregnation titers of 3 ⁻14
mg copper per gram of
cotton. The copper/ascorbate
cotton analog formulations
were characterized
spectroscopically, and the
copper titer was quantified
with ICP analysis and probed
for peroxide production
through assessment with
Amplex Red. All analogs
demonstrated antibacterial
activity. Notably, the
treatment of unbleached
cotton with low levels of
ascorbate (~2 mg/g cotton)
resulted in a 99 percent
reduction in Klebsiella
pneumoniae and Staphyloc
occus aureus. In situ
synthesized copper/ascorbate
nanoparticles retained activity
and did not leach out upon
prolonged suspension in an
aqueous environment. An
assessment of H₂O₂ effects on
fibroblast proliferation is
discussed in light of the
copper/cotton analogs and
wound healing.
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influencing cell signaling or
antimicrobial effects to
promote healing. Historically,
many commercial dressing
materials have addressed the
physical aspects of wounds,
e.g., acting as a physical
barrier to further injury,
providing an optimal level of
moisture, and removing
excess exudate [54,55].
However, in recent years,
focus on mechanism-based
wound dressing research has
addressed wound healing
science concepts with the goal
of incorporating functionality
into dressings and
biomaterials that enable the
promotion of or re-entry into
the major phases of wound
healing. Integration of
functional design features in
dressings have addressed
growth factor delivery,
protease modulation,
antimicrobial activity,
inhibition of biofilms, and
prevention of scar formation,
which enable the
proliferative, inflammatory,
and remodeling phases of
wound healing. Low-level
hydrogen peroxide generation
(5–50 μM) has also been a
subject of therapeutic interest
for some time with regard to
the promotion of cell
proliferation Thus, developing
an improved understanding of
how wound dressings may be
designed to address critical
unsolved issues in wound
repair and treatmen is an
impetus for the development
of safe, economical, and
highly functional materials for
patients. Toward that end, we
have characterized a series of
formulations based on the
inherent properties of the
cotton fiber to produce
hydrogen peroxide with an
ultimate goal of
understanding how hydrogen
peroxide levels may be
modulated for stimulating
healing and antibacterial
effects. The materials of this
study demonstrated
antibacterial effects, but the
attenuated growth of
fibroblasts suggest the
importance of developing
improved analogs that
modulate hydrogen peroxide
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Design and Fabrication In this study, intelligent Eco
of Smart Diapers with diapers are made by
Antibacterial Yarn combining antibacterial yarns
coated with quaternary
ammonium salts with
conductive yarns to improve
caretaking for
urinary incontinence. The
combination of conductive
yarns and sensors can detect
the moisture content in eco-
diapers, and an alarm is sent
when moisture is significant. A
wireless module is used to
send detected signals to a
smartphone or tablet PC via
the Internet. This concept
is used for a scenario in which
nurses do not randomly check
on patients in a long-term
care institution. When used
offline, eco-diapers can send
caregivers an alarm for the
need to change diapers via
cell phones. The diameters of
the copper and silver-plated
copper fibers are 0.08 and
0.10 mm, respectively. Cotton
yarns are twisted with copper
and silverplated copper fibers
to form the conductive yarns,
which are 0.12 mm in
diameter. Moreover, 30-count
cotton and 150 D nylon yarns
are coated with quaternary
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levels and assessing them in
appropriate vitro models. It
also raises considerations
about discerning the overlap
between bacteriostatic levels
of hydrogen peroxide and
fibroblast toxicity when
developing treated wound
dressing material, and the
relative effects. Although
numerous reports have been
made on developing improved
models to assess the cell
signaling effects of hydrogen
peroxide, few studies have
sorted through the complex
cellular effects in the wound
that may occur with regard to
exogenous agents on cell
death and cell proliferation
versus antibacterial effects.
Future studies will focus on
developing systems to
examine the relative
cytotoxicity versus enhanced
cell proliferation so these
types of formulations can be
made tunable for
incorporation into cotton-
based dressing materials.
This study proposes the use of
antibacterial cotton and nylon
yarns to provide a novel
variety of eco-diapers; these
yarns are treated with
quaternary ammonium salts
to make them antibacterial.
The antibacterial effectiveness
of the woven fabrics was
evaluated. The test results
indicate that using quaternary
ammonium salts provides a
bacterial reduction
percentage higher than 99%
against Staphylococcus aureus
or coli bacillus. In addition,
wearable technology became
important research direction.
Previous studies have used
complicated methods to form
conductive textiles; this study
improves these methods by
combining woven fabrics and
electronic products for Eco
diapers. The synthesis of
metallic and functional yarns
highly decreases the
discomfort of eco-diaper
users. The nonwoven
interlayer of the eco-diapers is
combined with metallic yarns
to sense humidity. These two
parallels metallic yarns can
detect different hygroscopic
levels of eco-diapers and
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ammonium salt via dyeing examine humidity according

and finishing processes to
form antibacterial yarns. In
the current study, intelligent
eco diapers are tested for
their electrical and
antibacterial properties as
specified by AATC and JISL
test standards.
to electrical resistance.
Regardless of whether users
are the infants or the disable,
comfort, outlook, and position
of the tangible sensor should
all be considered. In addition,
a wireless transmission
module is used to send an
alert message to the smart
phones of caregivers via a
web-based notification
function. Therefore, a smart
diaper combined with a smart
phone removes the need for
caregivers to randomly check
the diaper status of patients.
This system can subsequently
prevent skin disease.
Moreover, the manpower
shortage in long-term care
institutions can be alleviated

5. Conclusion

According to EN ISO 14971 and EN ISO 10993-1 requirements, per literature search
and analysis in section 3, we have confirmed that the raw materials listed in below are
safe in biological and the biological risks of medical device manufactured by these raw
materials are acceptable：

 Neoprene (polychloroprene (PCP) )

 Cotton

6.3. Product Performance Test

The Lower Limb Brace should meet the quality requirements that raw material inspection
and final inspection should be conducted, please refer to Annex3_performance Test Report
about the inspection and test reports.

7 Post Marketing
7.1 Post-market Surveillance Plan

This Post-Market Surveillance Plan (PMS) plan is to address the residual risks
identified related to clinical safety and clinical performance of the device.
PMS methodologies
a) The PMS methodologies are carried out through reviewing relevant retrospective data
from patients previous exposed to Lower Limb Brace. Quality and Customer Service
gathers the customer feedbacks, and reviewing on a monthly basis.
b) The clinical investigation plan /study plan:
1) Study population and group of patients shall include the following population. The
study population is selected based on the product intended use.
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2) Quality department and customer service are responsible for analyzing the
customer feedback and submit management team to review.
3) Study objectives are gathering customer feedbacks for 1,000 units or one year
patients’ follow-up for each type of production. After analysis, Sales and quality team will
determine the endpoint of the study.
4) PMS studies shall be conducted by product type.
5) Where appropriate, such as a new risk identified through the PMS, the interim report
need to be generated to ensure continuous risk management based on clinical data.
6) In case of natural disaster, it might terminate the early study in the PMS site.
7) After gathering the clinical data, follow the following procedure to control data and
update the risk analysis when appropriate.

Table 1: PMS Study population selection, methodologies and timing design

Item PMS Method Department Time and frequency

1 Regular clinical evaluation Technical Dept Once per 3 years
2 Regular research on related literature Technical Dept Once per 3 years
3 Research on similar devices on the Sales Dept While there is similar
market device put on the
markets
4 Research on materials, operating Technical Dept While there is
principles and technologies of update on the
medical devices material, operating
principle and
technology of the
product
5 Research into new technologies Technical Dept While there is new
technology
6 Research on product life Technical Dept Long-term
continuous study
7 Study adverse events and establish Quality Dept While adverse event
and implement the medical device occurs
notification and withdrawal control
procedures
8 Solicit relevant improvement Sales Dept Once per year
opinions from customers, measure
customer satisfaction and establish
and implement customer related
process control procedures
9 Solicit relevant improvement Sales Dept Conduct customer
opinions from customers, measure satisfaction survey
customer satisfaction, establish and once per year
implement customer satisfaction
survey control procedure
10 Pay close attention to the recalled Sales Dept While there is
products and establish and product recall
implement the medical device
notification and withdrawal control
procedures
11 Research on new product related Technical Dept While there is
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standards product related

standard updated
12 Study of new product-related Technical Dept While there is
regulations product related
standard updated.

Risk Analysis of Post Marketing Surveillance

Risk analysis indicates all risks associated with the identified hazards have been
evaluated. After appropriate retirement actions of reducing these risks have been
taken, the overall level of risks of the product is acceptable with regard to the intended
application and use of the products. Therefore, the post-marketing follow-up plan is
designed to follow up the clinical performance of the device through Lower Limb
Brace customers and analysis on monthly basis.

7.2 Post-market Surveillance Report

7.2.1 Post-market Surveillance data

Base on the post-market surveillance plan we made in section 7.1, the corresponding data
collected are shown as in table 3. The customer feedback of the proposed device and similar
device are shown in the table 2.

Table 2. Customer feedback list of the proposed device

NO. Description Root Cause Corrective actions state

0 / / / /

Table. 3 Post Market experience of similar device

Area Time Quantity Complaints Adverse events

2017 0 0 0
2018 50000 0 0
China
2019 70000 0 0
2020 50000 0 0
2017 0 0 0
2018 200000 0 0
USA
2019 500000 0 0
2020 800000 0 0
2017 0 0 0
2018 150000 0 0
EU
2019 250000 0 0
2020 550000 0 0
Total 3070000 0 0
Table 4. PMS Study Result

Item PMS Method Department Data

1 Regular clinical evaluation Technical Dept Please refer to Clinical
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Evaluation Report
2 Regular research on related Technical Dept Please refer to clinical
literature literature attached to Clinical
Evaluation Report
3 Research on similar devices on Sales Dept Please refer to Clinical
the market Evaluation Report
4 Research on materials, Technical Dept No update on the material,
operating principles and operating principle and
technologies of medical technology of this product.
devices
5 Research into new technologies Technical Dept No new technology
6 Research on product life Technical Dept No change of shelf life.
7 Study adverse events and Quality Dept No, there is no adverse
establish and implement the event occurred.
medical device notification and
withdrawal control procedures
8 Solicit relevant improvement Sales Dept No customer feedback
opinions from customers, related to product safety and
measure customer satisfaction quality problem.
and establish and implement
customer related process
control procedures
9 Solicit relevant improvement Sales Dept Customer satisfaction survey
opinions from customers, was conducted once per
measure customer satisfaction, year and the
establish and implement result shows customers are
customer satisfaction survey satisfied to product quality
control procedure and safety.
10 Pay close attention to the Sales Dept No products recall occurred.
recalled products and establish
and implement the medical
device notification and
withdrawal control procedures.
11 Research on new product Technical Dept No new product related
related standards standard.

12 Study of new product-related Technical Dept The Europe Regulation about

regulations Regulation (EU) 2017/745
has released on 5th, May,
2017. We
updated this CE technical
document based on the new
Medical Device Regulation
(EU) 2017/745, and
implement quality
management base on
the new Medical Device
Regulation (EU) 2017/745.

7.2.2 Safety and Effectiveness Conclusion

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By collecting and analyzing PMS data of the proposed device and similar device, the
technology of Lower Limb Brace is mature. Risk management, bench test, literature
analysis and post-market data has proven the safety and effectiveness of the
proposed device.
The risk identified in the device risk management documentation and literature has
been controlled. All the hazards and other clinically relevant information have been
identified appropriately. The literature results are enough to address the points we aim to
clarify and there is no need to get the new clinical information.
From the PMS data of the similar device, there is no significant risk were identified and
at the same time, the therapy was proved to be effective. So, the benefit is higher than the
risk.