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
Agenda
- 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 Should Attend
CEO’s, product managers, quality/regulatory/medical affairs managers, quality representatives of- Medical device manufacturer
- Importer
- Distributors
- Dealers
