NAMSA Webinar: 4 Pillars of IVDR: Integration Post-Market Surveillance, Risk Management, QMS and Performance Evaluation
February 19 @ 11:00 am - 12:00 pm
Join BioOhio member NAMSA for the webinar 4 Pillars of IVDR: Integration Post-Market Surveillance, Risk Management, QMS and Performance Evaluation on February 19 at 11am EST.
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:
- Quality Management System (QMS)
- Post-Market Surveillance (PMS) System
- Risk Management System
- Vigilance System
NAMSA invites you to join an upcoming webinar as they 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
Click here to learn more and register!