Industry Preparations for the EU IVDR

Alexandra Stamati, Director, Quality Assurance-PRRC at Medicon Hellas SA, offers a guide to the requirements and process of preparing for EU IVDR from the perspective of industry

Industry Preparations for the EU IVDR

Alexandra Stamati, Director, Quality Assurance-PRRC at Medicon Hellas SA, presented a session at MedTech Summit 2020 on industry preparations for the EU IVDR. She goes through the requirements and process of preparing for EU IVDR, including:

QMS and PMS
Risk management
Performative evaluation
Economic operators
Technical documentation

Watch the full on-demand session by clicking on the video right.