MDR Auditing - Training of Internal Auditors in Relation to MDR

Gain knowledge about the MDR requirements not covered by ISO 13485 and understand the MDR requirements related to the QMS and their impact. Learn what to look for when auditing a QMS against the MDR requirements

Course objective and outcome

The following skills and competences are developed:

  • Knowledge about the MDR requirements not covered by ISO 13485
  • Understand the MDR requirements related to the QMS and their impact
  • What to look for when auditing a QMS against the MDR requirements

 Content

  • Risk Management
  • Unique Device Identifier & EUDAMED
  • Person responsible for regulatory compliance
  • Liability
  • Registration of economic operators & obligations (EU Rep, Distributors, Importers)
  • Regulatory compliance requirements including conformity assessment
  • Post Market Surveillance process
  • Vigilance
  • Clinical Investigation and evaluation process

 Who should attend

  • Quality Managers
  • Person responsible for implementation of MDR requirements into the QMS
  • Responsible persons performing internal & supplier audits

Trainer
Yann Cailler, Senior Project Associate, Medidee Services SA

 
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Kontakt

mp@medicoindustrien.dks billede
Morten Petersen
Uddannelseskonsulent
49184703