Duration: 4 hours | | 1:30 – 5:30 PM Central Europe Summer Time | 7:30 – 11:30 AM US Eastern Standard Time
Date: June 18th 2024, Online
Speaker: Somashekara Koushik Ayalasomayajula


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
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
Data required for device registration
Data exchange options
- Introduction to vigilance & post market surveillance module
- EUDAMED impact on QMS

Training format:

• Presentations with interactive discussions
• Group and individual exercises
• End of training assessment


Price: EUR 415 incl. course material and certificate