Join us for an engaging morning of practical case studies and regulatory insights with a special focus on the Belgian context.
Agenda:
Arne Sunaert (Coordinator, MDSW Development Domain at FAMHP)
- Medical Device Software (MDSW) - The role of FAMHP, regulatory challenges and what comes next - An MDR/IVDR Competent Authority perspective
Pieter Bogaert (Senior Consultant RA IVD, QbD)
- Clinical Performance Evaluation of Medical Device Software
Agnieszka Swiatek (QARA Manager, XEOS Medical)
- Upcoming revision of IEC 62304
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
