Is Your CE submission ready for a Notified Body? 

This blog explores the key regulatory challenges and practical considerations involved in developing companion diagnostics for clinical trials in the US and EU.

Class B and Class A-sterile IVDs now need notified body sign-off. Get the 8-step plan to apply before May 26, 2027, and what the IVDR 2.0 proposal could change.

ISO 9001:2026 has been published: translate ISO 9001:2026 developments in your supply chain into effective ISO 13485 supplier controls.