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Post-Market Surveillance for Medical Devices in Europe

$49.00

This lecture describes the key changes regarding post market surveillance and what companies should do to meet their new obligations. After the course you can take a final test to receive your certification. Enjoy!

Description

Why take this course

This Meditrial Recorded Video Lecture By Dr Monica Tocchi is designed to help gain detailed knowledge of implementing your PMS procedure, applying the requirements listed in Annex III / IV, and understanding whats new in the MDR for PMS and PMCF.

What I will learn

  • Post-Market Surveillance (or PMS)
  • Post-Market Clinical Follow-up (or PMCF)

Skills I will gain

  • Understand PMCF and PMS and their relevance for medical device assessment
  • Integration with QMS and RMS
  • Understand the role of PRRC
  • Gain thorough knowledge of PMS, PM plan, and PM report
  • Know the requirements of PSUR and EUDAMED
  • Understand role of Notified Bodies in Surveillance Audits

 

TOPICS

  • Introduction (00:03:13)
  • PMS Requirements in the MDR (00:02:25)
  • PMS vs PMCF (00:05:33)
  • Economic Operators and PRRC (00:06:22)
  • Post-Market Surveillance (00:01:54)
  • PMS Plan: Content Requirements (00:01:28)
  • Periodic Safety Update Report (PSUR) (00:02:07)
  • Surveillance Audits (00:01:26)
  • Timelines for the application of MDR provisions for PMS (00:00:59)

  • Final Test – Post-Market Surveillance for Medical Devices in Europe
  • Certification

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