Seminar Medical Device Regulation (EU) 2017/745
Dive into a stress-free world of the new MDR: For all those who want to find out about the new Medical Devices Regulation and its consequences for your company. The training provides a brief and practical introduction to the new regulatory requirements for the medical device industry.
The seminar is aimed at specialists and managers in medical device industry, as well as importers and dealers who want to find out about the new Medical Devices Regulation MDR (EU) 2017/745 and its consequences for their own companies.
The training provides practical knowledge on the new regulatory requirements for the use of medical devices and focuses on the following topics:
- Basics and definitions of the new Medical Device Regulation (MDR)
- Requirements and roles of different actors such as manufacturers, importers, dealers or suppliers
- Differences in conformity assessment and classification of medical devices compared to the Medical Device Directive 93/42/EEC
- Contents and changes in the technical documentation
- More stringent requirements in clinical evaluation
- Scrutiny process
- New topics in the area of Post Market Surveillance
- EUDAMED Database and Unique Device Identifier (UDI)
Registration via: https://www.saq-qualicon.ch/aus-und-weiterbildung/seminare/Medical-Device-Regulation.php