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.

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