How to Create A PMS Plan and Report According to EU MDR 2017/745 Article 83-86?

Instructor: Frank Stein
Product ID: 706533
Training Level: Intermediate to Advanced
  • Duration: 90 Min
The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. One hot topic is the focus on the "Post-Market- Surveillance-Process" and the new requirements e.g. reporting to Competent Authorities and Notified Bodies and how this process is connected to other processes in the quality management system according to ISO 13485:2016. The understanding of these changes and how to implement changes until May 2021 is essential to keep your certificates and to keep the market entry open.
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Why Should You Attend:

You should attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in your current quality management system according to ISO 13485:2016 like the post-market-surveillance plan and report and how to create the annual PSUR – Performance Safety Update Report to the Notified Bodies and EUDAMED in a simple and quick way. Your implementation time until May 2021 is short and need smart ideas to reach the right level to pass the quality management audit by your certification company or notified body.

Learning Objectives:

  • Introduction, who must apply the new EU MDR 745/2017 requirements
  • Overview about the changes of the EU MDR 745/2017 regarding “Post Market Surveillance” of your products
  • Explaining of each change
  • Smart and fast ways to implement the changes in your quality management system
  • Fast track internal audit to approve the changes

Areas Covered in the Webinar:

  • How to define a “Post-Market-Surveillance-Process”?
  • How to create the new required reports for the Notified Body and the Competent Authorities?
  • How to do adjustments in the management review
  • How is the Post-Market-Surveillance-Process” connected to clinical evaluation, customer feedback, complaints and vigilance?

Who Will Benefit:

CEO’s, product manager, quality/ regulatory / medical affairs manager, quality representatives of

  • Medical device manufacturers
  • Importers
  • Distributors
  • Dealers

who work with European Union

Instructor Profile:
Frank Stein

Frank Stein
Senior Expert Medical Devices, Frank Stein healthcare projects

Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.

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