Risk Management Updates

What to do with your process to meet the EU MDR/IVDR requirements.

This webinar provided the background and requirements that medical device manufacturers will need for creating, updating or otherwise remediating the risk management files to meet the requirements of the European Medical Device Regulations (EU MDR), In vitro Diagnostic Regulation (IVDR) and other worldwide requirements. This presentation is designed to set the foundation for your medical device risk management files in alignment with Clinical Evaluation Reports (CERs) to keep your notified body satisfied with the documentation to place their CE mark on your device and keep it on the market in the European Economic Area (EEA).