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This webinar will help you understand the requirements of the new medical device regulation EU MDR 745/2017 and teach you how to create the reports. The understanding of the changes and how to implement last-minute changes until May 2020 is essential to keep your certificates and to sell your products after May 2020 to the European Union. The learning objectives are:
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.
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 Activities” and the frequently reporting to the Notified Bodies and the Authorities. Attend this webinar to keep yourself up to date. Learn how to understand the requirements and how to create the reports.
Prof. Dr. Dr. h.c. Frank Stein, medical & physical engineer, medical engineering experience since 25 years, food experience since 6 years with HACCP, IFS 6.1, BRC 8, FSSC22000, risk management experience since 15 years, experience with borderline products food-medical, international project and regulatory consulting experience in EMEA, APAO, LATAM, US.