Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017
Prof. 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, Arabic Countries, Latin-America.
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 Authorities and Notified Bodies and how this process is connected to other processes. The understanding of these changes and how to implement last-minute changes until May 2020 is essential to keep your certificates.
- Introduction, who must apply the new EU MDR 745/2017 requirements
- Overview of the changes in the EU MDR 745/2017 regarding “Post Market Surveillance” of your products
- Explaining each change
- Smart and fast ways to implement the changes in your quality management system
- Fast track internal audit to approve the changes
- How to define a “Post-Market-Surveillance-Process”?
- How to create the newly 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?
Course Level - Intermediate and Advanced
Who Should Attend
- CEO’s Product Manager
- Quality/Regulatory/Medical Affairs Manager
- Quality Representatives of
- Medical Device Manufacturer
Who works with the European Union?
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 in a simple and quick way. Your implementation time until May 2020 is short and need smart ideas to reach the right level to pass the quality management audit by your Certification company or notified body.