QUALITY SYSTEM PROCEDURE

Document. ID & Rev.

SM/QSP/23-R5 Effective Date 15.05.2021
Number
TITLE POST-MARKET SURVEILLANCE
1.0 PURPOSE
The purpose of this procedure is to provide a process for:
1. Actively and systematically gathering, recording and analyzing relevant data on the
quality, performance and safety of a device throughout its entire lifetime for drawing
the necessary conclusions and;
2. Determining, implementing and monitoring any preventive and corrective actions.
2.0 SCOPE
 Covers all the products manufactured and sold by the company and it is carried out as
per MEDDEV 2.12/2 rev2 Risk class and appropriate of type of device.
 Systems for monitoring and documenting post market experience are based on
information received from the field.
 Data gathered by the SURGIMEDIC's post-market surveillance system shall in particular
be used:

(a) To update the benefit-risk determination and to improve the risk management;
(b) To update the design and manufacturing information, the instructions for use
and the labeling;
(c) To update the clinical evaluation;
(d) To update the summary of safety and clinical performance;
(e) For the identification of needs for preventive, corrective or field safety corrective
action;
(f) For the identification of options to improve the usability, performance and safety
of the device;
(g) When relevant, to contribute to the post-market surveillance of other devices;
(h) To detect and report trends; and
(i) The technical documentation shall be updated accordingly.
3.0 RESPONSIBILITY
MR
Quality Manager
Marketing Manager
Managing Director
Importer & distributor

This document contains confidential information that belongs to SURGIMEDIC. The document cannot be
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 QUALITY SYSTEM PROCEDURE
Document. ID & Rev.
SM/QSP/23-R5 Effective Date 15.05.2021
Number
TITLE POST-MARKET SURVEILLANCE
4.0 PROCEDURE
4.1.General
STS shall plan, establish, document, implement, maintain and update post market
surveillance system proportionate to the risk class and type of device.
The extent of PMS that is required for the product is determined. The input for post-market
surveillance activities is received from different sources.

4.2.Sources of PMS Information

4.2.2. There are two types of sources for the PMS system. They are reactive and proactive
sources.
4.2.1.1 Reactive Sources
The sources of inputs for reactive PMS system include:
 Customer complaints and warranty claims
 Vigilance
 Safety Corrective Action
 Customer feedback
 Detection of manufacturing problems
 Device misuse
 Continuing market viability

This document contains confidential information that belongs to SURGIMEDIC. The document cannot be
Warning fully or partially copied without the prior written approval of the designated Directors of the organization.
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 QUALITY SYSTEM PROCEDURE
Document. ID & Rev.
SM/QSP/23-R5 Effective Date 15.05.2021
Number
TITLE POST-MARKET SURVEILLANCE
4.2.1.1 Proactive Sources
The source of inputs for proactive PMS system is PMCF which divided into 2 types:
a) PMCF General Method:
 Gathering of Clinical experience gained (Expert Panels)
 Customer surveys
 User feedback via training programs or sales reports
 Experience with similar devices
 Clinical literature review
 The media (as FDA Database and Safety Reports of the competent authorities)
 Retrieval studies on explants
 In-house testing
b) PMCF Specific Method:
 Evaluation of Suitable registers or PMCF studies
4.2.3. Information on few of the relevant PMS Sources:
a) Customer Feedback
 Customer feedback is a reactive source for PMS.
 Customer feedback is collected from the customers once in a year.
 Feedback is obtained on all aspects of customer interaction from initial contact to
sign-off of project.
 The feedback data include feedback on indication of use, instructions for use and
customer satisfaction.
 A customer feedback format seeking opinion on all above aspects is sent to the
customer with a request to return duly filled. When customer does not respond for
any reason, the marketing team collects opinion verbally during a meeting or on
phone and details entered in the format.
 Data collected are analyzed through use of any suitable techniques.
 The results of analysis are shared with others contributing to
satisfaction/dissatisfaction for deciding causes and to initiate corrective actions,
wherever necessary.
 The data are presented for final discussion in management review.

This document contains confidential information that belongs to SURGIMEDIC. The document cannot be
Warning fully or partially copied without the prior written approval of the designated Directors of the organization.
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 QUALITY SYSTEM PROCEDURE
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SM/QSP/23-R5 Effective Date 15.05.2021
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TITLE POST-MARKET SURVEILLANCE
b) Customer Complaints
 A customer complaint is a reactive source for PMS.
 Customer complaints will be forwarded to the respective department through the
sales department.
 All customer complaints will be acknowledged by mail within one working day.
 Subsequently the pertinent functional heads shall resolve the complaint if required
through direct interaction with the customer or customer representative.
 On closure of the complaint, intimation to that effect shall be communicated to the
sales department.
 Reporting shall include the adherence to production schedule, status of
development parts and improvement projects identified and their status.
 Records of customer complaints/Advisory Notices and their status are maintained.
 Analysis of customer complaints helps to detect the manufacturing problems,
product quality improvements, knowledge of long-term performance or
complications etc.
c) In house testing
 Sampling and testing of device is carried out as per the standard operating
procedure for measuring.
d) Reports from Regulatory Authorities
 A report from regulatory authorities is a proactive source for PMS.
 Reports of incidents from regulatory bodies for a similar device manufacturer can
be reviewed if available.
 Non-conformity reports of audits can be used as a feedback for post-market
experience.
 Review of these data is considered as an information which can be an early
warning for quality issues of the product and it is communicated immediately to
the concerned people if necessary.
e) Literature Review
 Literature of the similar devices is an important source of proactive source for
PMS.
 Journals regarding devices are reviewed and information collected and
documented.

This document contains confidential information that belongs to SURGIMEDIC. The document cannot be
Warning fully or partially copied without the prior written approval of the designated Directors of the organization.
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SM/QSP/23-R5 Effective Date 15.05.2021
Number
TITLE POST-MARKET SURVEILLANCE
4.3. PMS PLAN

A PMS plan should be established considering both the reactive and proactive sources and it
depends on classification of product. It should consist of schedule for the collection of data,
periodic review of the collected data as well as the literature. There should be responsible
personnel for the collection of the PMS sources. The residual risks are taken as inputs for
the further evaluation in the PMS system.

Article 83 to 86 – Annex III & XIV

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TITLE POST-MARKET SURVEILLANCE
4.4. PMS PROCESS

4.5. PMS REPORT

- A PMS report should contain the following knowledge or feedback. The manufacturer
decides priorities since it is different for different products.
 detection of manufacturing problems
 product quality improvement
 confirmation (or otherwise) of risk analysis
 knowledge of long-term performance/reliability and/or chronic complications
 knowledge of changing performance trends

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Warning fully or partially copied without the prior written approval of the designated Directors of the organization.
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 QUALITY SYSTEM PROCEDURE
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SM/QSP/23-R5 Effective Date 15.05.2021
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TITLE POST-MARKET SURVEILLANCE
 knowledge of performance in different user populations
 feedback on indications of use
 feedback on instructions for use
 feedback on training needed for users
 feedback on use with other devices
 feedback on customer satisfaction
 identification of vigilance reports
 knowledge of ways in which the device is misused
 feedback on continuing market viability
- Based on the different PMS sources, the PMS report is prepared and a conclusion is
derived which contains the output that must be transferred to further actions which is
communicated annually through the management review meetings.
- For class Is, IIb & III devices, SURGIMEDIC shall prepare a post market surveillance report
summarizing the results and conclusion of the analyses of the post-market surveillance
data gathered as a result of the post-surveillance plan together with a rational and
description of any preventive and corrective actions taken.
- A PMS Report for class I device shall be:
 Updated periodically without timeframe;
 A part of technical documentation and;
 Available to the Notified Body (NB) and upon request to the Competent
Authority (CA)
4.6. Periodic Safety Update Report (PSUR):
- For Class IIb & Class III devices, SURGIMEDIC shall prepare a Periodic Safety Update
Report (PSUR) for each device and where relevant for each category or group of devices
summarizing the results and conclusion of the analyses of the PMS data gathered as a
result of the PMS Plan together with a rationale and description of any preventive and
corrective actions taken. Throughout the lifetime of the device concerned, that PSUR
shall set out:
a) The conclusion of the benefit-risk determination;
b) The main findings of the PMCF; and

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Warning fully or partially copied without the prior written approval of the designated Directors of the organization.
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TITLE POST-MARKET SURVEILLANCE
c) The volume of sales of the device and an estimate evaluation of the size and other
characteristics of the population using the device and, where practicable, the usage
frequency of the device.
- For Class IIb and Class III devices, The PSUR shall be:
 Update at least annually;
 A part of technical documentation and;
 Available to the Notified Body (NB) and upon request to the Competent
Authority (CA).
- For Class III devices or Implantable devices, SURGIMEDIC shall submit the PSUR to
Electronic System to the Notified Body for review and evaluation which is then with
Notified Body Evaluation be made available to competent authorities through that
electronic system shared with the Competent Authorities.
4.7. OUTPUT OF PMS
 Contribution or output of the PMS data in concrete and / or new reports to:
 Update Summary of Safety and Clinical Performance,
 Update PSUR (Periodic Safety Update Report) with the Summary of PMS data analysis
and conclusion as a result of the PMS plan
 The conclusion of the benefit-risk determination;
 The main findings of the PMCF;
 Any related CAPA taken;
 Sales data, use population or frequency of use;
 Updated the Risk Management to improve it;
 Update the Clinical Evaluation without timeframe, but should be aligned with PSUR
timeline;
 Detect and report trend in accordance with Trend reporting explained in SOP of
Vigilance;
 Contribute to PMS of other devices, If relevant;
 Update the design and manufacturing information, the instructions for use and the
labeling;
 For the identification of needs for CAPA or Field safety corrective action (FSCA) and;
 For the identification of options to improve the usability, performance and safety of
the device.

This document contains confidential information that belongs to SURGIMEDIC. The document cannot be
Warning fully or partially copied without the prior written approval of the designated Directors of the organization.
The content in this document is intended only for the internal stakeholders.
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SM/QSP/23-R5 Effective Date 15.05.2021
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TITLE POST-MARKET SURVEILLANCE
 Following are the relevant procedures for further actions after post market surveillance.
 Handling of Complaints from Customers
 Recall & Advisory Notices
 Internal Audit
 Corrective and Preventive Action
 Risk Management Process
 Clinical Evaluation
 Vigilance
The PMS report & PSUR collectively shall be reviewed with the Notified Body during the
surveillance audits or upon request and feedback of the Notified Body will be incorporated &
appropriate action taken.
5.0 REFERENCE
 EN ISO 13485:2016: Clause 8.2.1-Customer Feedback
 MEDDEV 2.12/2 - Rev.2: Post Market Surveillance – A guide for Manufacturers &
Notified Bodies
 MEDDEV 2.12/2 - Rev.2: Post Market Clinical Follow-Up Studies – A guide for
Manufacturers & Notified Bodies
 EN ISO 14971:2012 Medical Devices – Application of Risk Management to Medical
Devices
 MEDDEV 2.7/1 rev.4 Clinical Evaluation: Guide for Manufacturers and Notified Bodies
under MDD 93/42/EEC + 2007/47/EC
 MDR 2017/745/EU
- Chapter VII (Post-market surveillance, vigilance and market surveillance) .
- Article 83: Post-market surveillance system of the manufacturer.
- Article 84: Post-market surveillance plan (PMSP).
- Article 85: Post-market surveillance report (PMSR).
- Article 86: Periodic safety update report (PSUR).
- Article 92: Electronic system on vigilance and on post market surveillance.
- Annex III (Technical documentation on post market surveillance)
6.0 TEMPLATES
Post Market Surveillance Plan MKT/F/08
Post Market Surveillance Report MKT/F/09

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SM/QSP/23-R5 Effective Date 15.05.2021
Number
TITLE POST-MARKET SURVEILLANCE
Periodic Safety Update Report (PSUR) MK/F/21

7.0 REVISION HISTORY

Revision No. Release Date Reason Next Review Date

R0 12.03.2011 Initial Release NA

R1 14.08.2012 EN ISO 13485:2012 updating NA

Updating of the procedure based on Internal
R2 22.02.2015 NA
audits
Updating of the procedure based on Internal
R3 12.10.2016 NA
audits
R4 04.10.2018 EN ISO 13485:2016 Updating 03.10.2020
Updating according to MDR 2017/745/EU
R5 15.05.2021 NA
Regulations

………………………………………………………..End of the Document…………………………………………………………………

Prepared by Reviewed by Approved by

Sign : Sign: Sign:

Marketing Manager Management Representative Managing Director

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