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
- Risk Management
- Unique Device Identifier & EUDAMED
- Person responsible for regulatory compliance
- Registration of economic operators & obligations (EU Rep, Distributors, Importers)
- Regulatory compliance requirements including conformity assessment
- Post Market Surveillance process
- 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
Michael Maier, Senior Partner, Medidee Services SA
"It was nice to get another view on our interpretations"
"It gave a very nice overview of the MDR requirements"
"The slides form was very good information for audit checklists"
Participants, Fall 2019