European Legal Framework

Regulatory approval (US vs EU) ((EPL15))


Description
Training objectives:

• Understand the basis of the US & EU Medical Device Regulation
• Understand differences between US and EU regulatory framework

Training content:

• Review of EU regulatory framework for medical devices
• Define steps for CE marking a medical device
• Review legal framework for conducting a clinical investigation
• Review key aspects in the development of a medical device
• US Quality System Regulation
• US Medical Device Regulation
• FDA Inspection
Content
  • TRAINING
  • Practical information
  • Presentation Day 1
  • Presentation Day 2
  • Recording Day 1
  • Recording Day 2a
  • Recording Day 2b
  • Classification according to Medical Device Regulation (MDR)
  • Case Study 1
  • Case Study 2
  • Case Study 3
  • Case Study 4
  • Case Study 5
  • EVALUATION
  • Training feedback
  • Post-training assessment
  • Training content
Completion rules
  • All units must be completed
  • Leads to a certificate with a duration: Forever