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


EUR 405 incl. course material and certificate


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