Go to Client Portal

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

Access On-Demand Webinar Here. 

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

*By registering for this event, you are providing NAMSA consent to contact you directly regarding NAMSA’s services. The information you are providing will be processed by NAMSA to better understand your product needs and interests. At any time, you can submit a request to withdraw your consent for the use of information provided by you by contacting us at: communications@namsa.com. For additional information, please visit our Privacy Policy or contact us at privacy@namsa.com

NAMSA uses a third-party provider, GoToWebcast, to host NAMSA webinars. For information related to GoToWebcast’s privacy policy and utilization of information, please contact GoToWebcast directly.