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post market surveillance | MDR

Post-Market Surveillance: A Concise Overview of Requirements

on 5 October 2021 | By Celeste Maksim, PhD, RAC, RQM+
Following the May 2021 deadline, medical device manufacturers now have an MDR-compliant post-market surveillance (PMS) system in place. However, there are still many issues and questions around this topic which need addressing.
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Q&A

Q&A: PMCF User Feedback Surveys

on 21 June 2021 | By Celeste Maksim, PhD, RAC, RQM+
 
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PSUR periodic safety update report

How to Create a Compliant Periodic Safety Update Report (PSUR) Under EU MDR and EU IVDR

on 28 April 2021 | By Celeste Maksim, PhD, RAC, RQM+
The requirement for a periodic safety update report (PSUR) or post-market surveillance report (PMSR) is new under EU MDR and EU IVDR. MDD and IVDD had post-market requirements, but the MDR and IVDR requirements are more formal, and for most classes, these reports must be updated and submitted to notified bodies (NBs) on an annual or biennial basis. 
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News

Top Ten Tips and Best Practices for PMCF Surveys Under EU MDR

on 10 November 2020 | By Celeste Maksim, PhD, RAC, RQM+
10 November 2020 - RQM+ experts have come up with a list of our top ten suggestions for mastering Post-Market Clinical Follow-up ("PMCF") Surveys under the European Union's Medical Device Regulation.
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