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Post-Market Surveillance Procedure (SYS-019)

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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.
Post Market Surveillance Post Market Surveillance Procedure (SYS 019)
SYS-019 Post-Market Surveillance Procedure/Form

SYS-019 Post-Market Surveillance Procedure/Form

Price: $299.00

Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download. 
Post Market Surveillance Post Market Surveillance Procedure (SYS 019)

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To review a sample Medical Device Academy procedure click below:

managment review sample SOP Post Market Surveillance Procedure (SYS 019)