MDRTraining
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ISO 13485 Alignment

15 min read

Learning Outcomes

  • Map ISO 13485:2016 clauses to corresponding MDR Article 10(9) requirements
  • Identify gaps between ISO 13485 and MDR-specific obligations (UDI, PRRC, PMS)
  • Describe strategies for closing the gap in an existing ISO 13485 QMS
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