James Hewitt

Company: TÜV SÜD

Job title: IVD Business Line Manager & Senior Specialist (CDx)

Seminars:

Panel Discussion: Strengthening the Interface between Competent & Notified Bodies to Define a Unified Path Towards IVDR Compliance for Streamlined Approvals 8:30 am

What are the current and future expectations for CDx conformity? How closely are the new UK regulations expected to mirror or diverge from IVDR? How are notified bodies harmonising their interpretation of performance studies, from a technical and regulatory perspective? What is the expected interplay between IVDR and the enforced European AI act? And what…Read more

day: Day 2 AM