This procedure provides the process and defines the practices that must be followed for performing Post Market Surveillance in compliance with the regulatory requirements. The objective is to ensure the safety and performance of the medical device after it has been placed on the market, to identify and assess any adverse events, and to implement appropriate corrective and preventative actions (CAPAs).
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Signed V8 RB 15.07.2024
This procedure applies to all medical devices manufactured and marketed by Envision Africa.
Approval: Author of the document, Marelize Robertson
Changes: Author of the document, Dean Kowalski
Post market issues may be identified through a variety of sources, including analysis of adverse event reports, a recall or corrective action, reports from other governmental authorities, or the scientific literature. Post Market Surveillance (PMS) activities is the systematic collection of data on the performance of devices during the post marketing phase exist in different countries ISO13485 Clause 5.4.2
QMS - Quality Management System
SOP – Standard Operating Procedure
PMS – Post Market Surveillance
MD – Managing Director
NCCA – Non-Conformance Corrective Action
ISO13485 Clause 4.2
Procedure for Preventative and Corrective Action and Handling of Non-Conforming Products.
Data Analysis Standard of Procedure
8.1.1. PMS is intended that Post market surveillance is performed for any device of the manufacturer where the failure of which would be reasonably likely to have serious adverse health consequences or which is intended to be:
implanted in the human body for more than one year, or
a life sustaining or life supporting device used outside a device user facility.
the company have nominated to also include Sterile products.
8.1.2. As PMS is the role of a manufacturer, it is through FEEDBACK arrangements by the distributor, through the supplier agreement, that the Distributor contributes to market information to the manufacturer.
8.1.3. Attach any reports in the SharePoint Folder.
8.2. Data Collection: Envision Africa collects data on the safety and performance of the medical device from various sources, such as:
Service Reports and maintenance records
Adverse event reports from regulatory authorities, healthcare professionals, or patients
Clinical studies and post-market surveillance studies
Scientific literature and databases
8.3. Data Analysis Envision Africa gathers data to identify and assess any adverse events or potential risks associated with the medical device. The Analysis includes the following:
Trend analysis to identify patterns or changes over time - non-conformance register
Comparison of the data with the expected performance of the device
Identification of potential causes of adverse events or trends
Assessment of the severity and frequency of adverse events or trends
Envision Africa implements a CAPA where required, based on the analysis of the data gathered. - refer to the CAPA SOP
In the event of noncompliance follow SOP NON-CONFORMANCE CORRECTIVE ACTION
The Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT refer Document
The analytical reviews of internal audits, and any other quality related matters, are reported through Data Analysis to management and as part of the input to management review.
The Trend analysis may identify any potential and recurring incidents, where corrective action must be reported at the management review to facilitate continual improvement.
Corrective actions identified during the evaluation will be documented via the PROCEDURE FOR PREVENTIVE AND CORRECTIVE ACTION AND HANDLING OF NONCONFORMING PRODUCT SOP. Based on the findings of the report, it may be necessary to update the relevant devices risk management modules & technical files
Revision 8; 15.07.2024 - RB - Change over to SharePoint Site
Revision 7; 07.03.2023 - MR - 07.03.2023 - DK - Purpose updated, Scope updated, 7. Renamed to References and Documents, 8.2. Add Section,
Revision 6; 14.10.2021 - MR - Updated
Revision 5; 05.08.2021 - MR - Reviewed
Revision 4, 23.06.2021 - TNA - Scope, Responsibilities, Risk based approach and Records, Approval added and new google site format Numbering
Revision 3 Digitally signed on 16.07.2018 by TNA
Revision 1-2, unknown due to google site change to new google sit
Name Retained in Retention period Hard copies Destroyed by
Non-Conformance Register SharePoint N/A N/A