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4 Pillars Of IVDR: Integrating Post-Market Surveillance, Risk Management, QMS & Performance Evaluation

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The European Union’s (EU’s) In Vitro Diagnostic Regulation (IVDR) clearly lays out that manufacturers must demonstrate performance, safety and possible risks/controls of products prior to availability within the European marketplace. With this requirement comes the reinforcement of the four main pillars and systems as described within the regulation:

  1. Quality Management System (QMS)
  2. Post-Market Surveillance (PMS) System
  3. Risk Management System
  4. Vigilance System

NAMSA invites you to join us for our upcoming webinar as we focus on how each of these elements are closely interlinked and how manufacturers should strategize and not re-invent the wheel to secure IVDR compliance. Webinar participants will leave with a better understanding of:

  • The requirements of a QMS system that leads to IVDR compliance
  • The role of the QMS system in IVDR conformity assessment
  • How risk management is tackled through ISO14971 harmonisation and expansion
  • The new requirements under PMS and how they expand further than ISO13485:2016
  • Implementation of QMS under IVDR guidance

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