EUDAMED

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)