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.
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 EN ISO 13485:2021. The understanding of this changes and how to implement changes is essential to keep your certificates and to keep the market entry open.
Agenda
- 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?
Speakers
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.Who Should Attend
CEO’s, product manager, quality/ regulatory/medical affairs manager, quality representatives of- medical device manufacturers
- importer
- distributors
- dealers
