Technical Documentation to Comply with the MDR and IVDR Training Course

  • 22-23 Nov 2022
  • Online Event

Description

Topics
  • Overview of the MDR and IVDR
  • Technical documentation/file content
  • Quality management system (QMS)
  • Compiling the technical documentation
  • Labelling
  • Notified Body experience
  • Conformity assessment
  • Post market surveillance
  • Requirements related to authorized representatives
  • Person responsible for regulatory compliance
  • Requirements for archiving technical documentation
Who should Attend
  • IVD regulatory affairs professionals
  • Medical device regulatory affairs professionals
  • Quality managers/associates
  • R&D personnel creating technical documentation
  • Business development managers
  • Product managers

Past Events

Important

Please, check "Technical Documentation to Comply with the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation)" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Medical device
Science: Health sciences, Life Sciences & Biology

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