If you are a Chinese manufacturer based in China and are interested in exporting medical and in-vitro diagnostic devices to Europe, this new seminar is for you!
In collaboration with TÜV SÜD and AKRA TEAM GmbH will guide you through all the compliance challenges and effective practices to place your medical and in-vitro diagnostic devices on the European market.
Topics to be covered:
- EU MDR/IVDR Status Update – Where do we stand 1 year after the date of application?
- Lessons learned with the implementation of economic operators’ requirements & Technical Documentation expectations
- Lessons learned with EU MDR/IVDR Initial Audit Process
- Clinical/Performance Evaluation and PMCF/PMPF expectations of notified bodies
- Q&A Session (Panel Discussion)