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European Legal Framework

Technical documentation (US vs EU) ((EPL17))


Description
Training objectives: 

• Understand MDR compliant technical documentation content and requirements
• Understand Medical Devices risk class impact
• Understand reviewer’s requirements

Training content:

• Introduction to Technical Documentation under MDR (Annex II and Annex III)
• Traceability within the Technical Documentation
• Risk class impact on Technical Documentation
• MDR Technical Documentation requirement impact on QMS
• Notified Body requirements on Technical Documentation (Conformity assessment process, Sampling, Significant changes)
Content
  • TRAINING
  • Presentation Day 1
  • Presentation Day 2
  • Recording Day 1 - Part 1
  • Recording Day 1 - Part 2
  • Recording Day 2
  • EVALUATION
  • Training feedback
  • Post-training assessment
  • Training content
Completion rules
  • All units must be completed
  • Leads to a certificate with a duration: Forever
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