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.

Learning Objectives:-

• 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?

Areas Covered in the Webinar:-

• 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?

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.

Who Will Benefit:-

• CEO’s, medical advisors, medical department manager, quality/regulatory affairs manager, quality representatives of
• Medical device manufacturers
• Importer
• Distributors
• Dealers