Training: In-person
Date: 13 October 2023
Time: 9:00 - 17:00 CEST
Price: € 699,-
Location: Novotel Amsterdam Schiphol Airport | Amsterdam, the Netherlands
Introduction:
Clinical evidence is the cornerstone of the IVDR and an area of a significant uplift in expectations. This session will look at what clinical evidence is needed to support IVDR and how to generate studies to meet the expectations pre- and post-market.
The following topics will be discussed during this workshop:
- Intended purpose
- Performance evaluation plan
- Analytical and Clinical performance
- Study objectives and intended population and user
- Clinical study performance plans
- Clinical study applications and ethics committee applications under the IVDR
- Running and monitoring a clinical performance study
- Preparing the Clinical Performance Report for new and legacy devices and CDx.
Trainers: