Discover blogs, articles, webinars, and resources all in one place.

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.

Join Qserve's Gert Bos and Bianca Lutters at the MDR Symposium on October 28 to make sense of the MDR transition together with industry experts.

Join Gert Bos at the Global Access 2026 in Galway to discuss international regulatory trends and connect with other QA/RA professionals.

Join the DIA Medical Devices and Drug-Device Combination Products Workshop: Post-Market Surveillance and Clinical Evidence with Bianca Lutters.