The video below outlines the procedure and templates you will receive when you purchase our Post-Market Surveillance Procedure (SYS-019) and Templates.
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Contents Sold with the Post-Market Surveillance Procedure
We have updated our Post-Market Surveillance Procedure (SYS-019) to include new EU requirements, including templates for the following:
- TMP-008 A D1 Post-Market Clinical Follow Up (PMCF) Checklist
- TMP-031 A D2 Post-Market Surveillance / Risk Management Plan Template
- TMP-032 A D1 Post-Market Surveillance (PMS) Report Checklist
- TMP-033 A D1 Periodic Safety Update Report (PSUR) Checklist
- LST-010 A D2 PMS Review Program Log
New Post-Market Surveillance Requirements
Post-Market Surveillance is the process in ISO 13485:2016 quality systems receiving the most amount of focus by Notified Body auditors due to updates in the European Medical Device Regulations:
The new regulations require an additional post-market surveillance section of your technical as defined in Annex III of the new MDR. The are also new requirements for creation of a Periodic Safety Update Report (PSUR) for Class IIa, Class IIb, and Class III devices. It is also an expectation for companies to conduct post-market clinical follow-up studies for most devices.
We also updated our post-market surveillance (PMS) plan template (TMP-031). The new template is now integrated with risk management requirements to include the risk management requirements in ISO 14971:2019, Clause 10 for collection of production and post-production information.
Additional Post-Market Surveillance Resources
If you are looking for additional guidance on post-market surveillance for medical devices, there is a new guidance available for post-market surveillance: AAMI/ISO DTIR 20416:2020 – Medical Devices – Post-Market Surveillance for Manufacturers.
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To review a sample Medical Device Academy procedure click below: