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)