Speaker: 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
- EUDAMED impact on QMS
Training Format
- Presentations with interactive discussions
- End of training assessment
Price
EUR 405 incl. course material and certificate