James Hewitt

Company: TÜV SÜD

Job title: IVD Product Expert

Seminars:

Creating Clarity on IVDR: Advancing our Understanding of the EMA Consultation Procedure for CDx Devices 7:30 am

• Bringing the global precision medicine community up to speed with the latest developments for CDx consultations under IVDR • Creating awareness of the requirements for the summary of safety and performance and instructions for use under IVDR and learnings from initial EMA consultations • Commercial implications and practical implementation of IVDR from the eyes…Read more

day: Day 2 Morning