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
 

"Really liked the structured approach. The instructor was very knowable about MDR"

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

"The trainer was very knowledgeable"

"Good and usable training material"

"PowerPoint you can use after the course"

Participants, Spring 2021