Why Should You Attend:
This webinar will provide an in-depth understanding into the following
- Introduction, who must apply the EU IVDR 2017/746 requirements?
- Overview about the changes of the EU IVDR 2017/746 regarding quality management
- What is the relationsship between the EN ISO 13485:2021 and the EU IVDR 2017/746?
- Which new requirements of the EU IVDR 2017/746 are not covered by the EN ISO 13485:2021? 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 IVDR 2017/746
- The obligations and roles of the EU IVDR 2017/746
- How work the regulation and the EN ISO 13485:2021 together?
- New and updated processes required by the EU IVDR 2017/746
- How to implement the required changes?
