Course Area
Availability
Available for 90 days after enrollment
Approximate Course Run Time
1 hour
Continuing Education Units
0.1
Course Fee
No charge
E-learning content is available on demand
Course Details
Join this webinar to hear Dr Liz Harrison, IVD Technical Team Manager at BSI, and Dr Erica Conway, BSI’s Global Head of IVD Medical Devices, talk about the Performance Evaluation requirements under the In Vitro Diagnostic Regulation (IVDR).
- Requirements and expectations around a Performance Evaluation Plan and Performance Evaluation Report
- Scientific Validity and how this fits into the Performance Evaluation and clinical evidence
- BSI lessons learned to date with initial IVDR submissions