Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation

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. This need smart ideas to reach the right level to pass the quality management audit by your certification company or notified body.

Why Should You Attend:

This webinar will provide an in-depth understanding into the following

• Introduction, who must apply the new EU MDR 2017/745 requirements?
• Overview about the changes of the EU MDR 2017/745 regarding quality management
• What is the relationsship between the EN ISO 13485:2016 and the EU MDR 2017?
• Which new requirements of the EU MDR 2017/745 are not covered by the EN ISO 13485:2016?
• The Role of the new harmonized version?
• Smart and fast ways to implement the changes in your quality management system
• Fast track internal audit to approve the changes

Who Will Benefit:

CEO’s, product manager, quality/ regulatory / medical affairs manager, quality representatives of

• Medical device manufacturer
• Importer
• Distributors
• Dealers