Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017

This webinar will help you understand the requirements of the new medical device regulation EU MDR 745/2017 and teach you how to create new required reports for the Notified Body and the Competent Authorities and how this process is connected to other processes in the quality management system according EN ISO 13485:2021.

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 ISO 13485:2021 like 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 need smart ideas to reach the right level to pass the quality management audit by your certification company or notified body.

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
• importer
• distributors
• dealers

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