EUDAMED

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:

1. User roles and hierarchy
2. Data required for actor registration
3. Obtaining SRN for economic operators (EU and non-EU) - EUDAMED Input screens

• Device and UDI registration module with the following subtopics:

1. Data required for device registration
2. Data exchange options

• EUDAMED impact on QMS

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