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
Our subject matter experts will provide definitions of the SOTA
Addressing SOTA for performance evaluation plan, performance evaluation reports, summary of safety and performance.
- IVDR requirements for SotA
- Definition of SotA
- How to establish SotA
- How to demonstrate SotA
Speakers
Liz Harrison, Global Head, IVD
Ana Chiva, Senior Technical Specialist and Scheme Manager
