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From Self-Declaration to Certification: Proving Performance Under IVDR

A session by Joanne Lebrun
Vice President, MDC Associates Inc.

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Categories covered by this session

About this session

  • Evaluation Plans
  • Ethics Committee (IRB)
  • Member State requirements
  • Managing a clinical study (protocol, data forms, deviations)
  • Preparing performance studies for submission
  • PMPF considerations and PMS

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