Knowing your Post-Market Clinical Follow-up (PMCF)

Speaker

Instructor: Frank Stein
Product ID: 706888
Training Level: Intermediate

Location
  • Duration: 60 Min
Attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in clinical post market surveillance into your current quality management system according to ISO 13485:2021. Your implementation needs smart ideas to reach the right level to pass the quality management audit by your notified body or authority inspection.
RECORDED TRAINING
Last Recorded Date: May-2023

 

$249.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$299.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

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Why Should You Attend:

The 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- Clinical Follow-up Plan” and the 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 EN ISO 13485:2021. The understanding of these requirements and how to implement into the quality management system is essential to keep your certificates up to date and to keep the market entry open.

Learning Objectives:

  • Introduction, who must apply the new EU MDR 745/2017 requirements for “Post-Market-Clinical-Follow-up (PMCF)”.
  • Overview about the changes of the EU MDR 745/2017 regarding “Post-Market-Clinical-Follow-up (PMCF)” of your products
  • Smart and fast ways to implement the “Post-Market-Clinical-Follow-up (PMCF)” in your quality management system

Areas Covered in the Webinar:

  • How to define a “Post-Market-Clinical-Follow-up-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-Clinical-Follow-up-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
  • importer
  • distributors
  • dealers

who work with European Union, European Economic Area, Switzerland and Turkey

Instructor Profile:
Frank Stein

Frank Stein
Senior Expert Medical Devices, Frank Stein healthcare projects

Prof. Dr. Dr. h.c. Frank Stein, medical engineer, medical engineering experience for 27 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, Brazil.

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