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

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.

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rec Recorded Link and Ref. material will be available in My Account Section
Last Recorded Date: May-2023

Download File Only

(PPT + Recorded Training File)

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(For multiple locations contact Customer Care)
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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

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.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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