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
Michael Maier, Senior Partner, Medidee Services SA

"The presenter was good and the exercises were good. It kind of help you to see if you had understood the training"

"Knowledgeable teacher"

"Liked the the expertise by the lecturer"

"Liked the great knowledge of the trainer and that he did share tips and tricks"

"Nice and comprehensive overview and helpful tools provided"

Participants, Fall 2020