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

Duration 90 Mins
Level Basic & Intermediate & Advanced
Webinar ID IQW20B0239

  • Responsibilities for “Post Market Surveillance” - activities
  • What reports are required
  • What is the input for the reports
  • How to create the reports
  • How often the reports required
  • Adjustments in the management review
  • How to work with the output of the reports in the quality management system processes and the technical documentation

Overview of the webinar

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:

  • Introduction, who must apply the new EU MDR 745/2017 requirements
  • Overview about the changes of the EU MDR 745/2017 regarding the “Post Market Surveillance” - activities
  • Explaining of each change
  • Smart and fast ways to implement the changes in your quality management system
  • Fast track internal audit to approve the changes
  • Who is responsible for the activities
  • Which (new) roles in the company required

Who should attend?

  • CEO’s
  • Medical Advisors
  • Medical Department Manager
  • Quality/Regulatory Affairs Manager
  • Medical Device Manufacturers
  • Importer
  • Distributors
  • Daealers

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.

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.

Faculty - Prof.Dr. Dr. h.c. Frank Stein

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.

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