Post Market Surveillance Procedure
Build a documented medical device post-market surveillance (PMS) process with this editable Microsoft Word procedure. Use it to plan how you collect and evaluate real-world feedback, document findings and connect them to risk management, clinical evaluation, vigilance and corrective action.
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Included: PMS procedure and sample post-market surveillance plan
The digital download includes the Post Market Surveillance Procedure and a sample PMS plan. Review the actual document previews above, then add the procedure to your cart to purchase the editable download.
What the procedure covers
Establishing and maintaining a systematic PMS process proportionate to the device and its risk.
Preparing and maintaining PMS plans and reports, with a sample plan to support implementation.
Collecting feedback from complaints, servicing, literature, clinical experience, distribution and other sources.
Evaluating trends, emerging hazards and changes in device performance.
Connecting PMS findings to PMCF, clinical evaluation, risk management, vigilance and corrective action.
Who this document is for
Medical device manufacturers and quality or regulatory teams establishing a PMS process or improving how post-market evidence flows through an existing quality management system. Adapt the editable document to your devices, markets, responsibilities and working practices.
Regulatory context
The procedure supports PMS activities under Regulation (EU) 2017/745 (EU MDR) and ISO 13485:2016. For U.S. quality systems, FDA QMSR incorporates ISO 13485:2016 with additional FDA requirements. Use this PMS procedure alongside the complaint handling and reporting processes applicable to your markets.
PMS, PMCF and safety reporting: choose the right document
PMS is the broader process for collecting and evaluating post-market information. PMCF focuses on clinical evidence and feeds the ongoing clinical evaluation within that PMS system. The PMCF plan, PMCF evaluation report and PSUR procedure below are separately sold related documents.
Post-Market Clinical Follow-Up Plan: define clinical follow-up objectives, methods and activities.
PMCF Evaluation Report: evaluate the findings from completed clinical follow-up.
Clinical Evaluation Procedure: carry new clinical evidence into the ongoing evaluation.
Periodic Safety Update Report (PSUR) Procedure: prepare periodic safety reporting when applicable.
Complaint Trending Procedure: assess complaint patterns as a source of PMS feedback.
Download and implementation
Supplied as one editable Microsoft Word document, with a sample PMS plan included as an attachment, in a digital download. Use the previews to assess the document before purchase and tailor it before implementation.
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read Medical Device Post-Market Surveillance and PSUR Planning for workflow guidance, a checklist and common mistakes.
Part of a procedure bundle
This procedure is also included in the Clinical Evaluation Procedure Bundle. Compare its included documents before purchasing individual items.
