Our blogs

Navigate AI-enabled medical device registration across Asia-Pacific. Discover key regulatory considerations, market strategies, and local requirements.

EN 18286 is here. See how it differs from ISO 13485, what is really new, and where to start updating your QMS for the AI Act.

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.

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

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.

Understand how EUDAMED and Swissdamed differ, where their data aligns and how to prepare for both 2026 registration deadlines.

Learn to what extent EUDAMED replaces national medical device registration requirements and when additional EU Member State notifications may still apply.

Learn the role of a China NMPA Legal Agent, legal requirements, responsibilities, and how Qserve supports medical device market access in China.