Is Your CE submission ready for a Notified Body? 

ISO 18969 has reached FDIS. See where the clinical evaluation standard stands, what it changes for manufacturers, and how to prepare before publication.

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.