This training currently has no open sessions. If you would like to attend, please leave us a message, and we will inform you when a new date is planned.
Training Objectives:
- Understand 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
Impact of EUDAMED on QMS
Training Format:
- Presentation with interactive discussions
- Exercises during the training
- End of training assessment (participants will receive a training certificate)