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
Areas Covered in the Webinar:
- The new scope of the EU MDR 2017/745
- The obligations and roles of the EU MDR 2017/745
- How work the regulation and the EN ISO 13485:2016 together?
- New and updated processes required by the EU MDR 2017/745
- How to implement the required changes until May 2020?
Who Will Benefit:
- CEO’s, product manager, quality/regulatory/medical affairs manager, quality representatives of
- Medical device manufacturer
- Importer
- Distributors
- Dealers
- who work with European Union
Course Content
- The new scope of the EU MDR 2017/745
- The obligations and roles of the EU MDR 2017/745
- How work the regulation and the EN ISO 13485:2016 together?
- New and updated processes required by the EU MDR 2017/745
- How to implement the required changes until May 2020?
Speaker
Frank SteinCourse Provider
Frank Stein,
