Training objectives:
- Understanding EUDAMED and its functional specifications
- Interpret EUDAMED data structures, requirements and business rules
- Impact of EUDAMED on QMS of economic operator
Training content:
- Introduction to EUDAMED
- EUDAMED readiness and time constraints
- Actor registration module with the following subtopics:
- User roles and hierarchy
- Data required for actor registration
- Obtaining SRN for economic operators (EU and non-EU) - EUDAMED Input screens
• Device and UDI registration module with the following subtopics:
- Data required for device registration
- Data exchange options
• EUDAMED impact on QMS