.png)
Learn how to structure a PMCF plan under the EU MDR. Walk through sections A to G of MDCG 2020-7 and avoid four common pitfalls before your Notified Body does.
-3.png)
Navigate AI-enabled medical device registration across Asia-Pacific. Discover key regulatory considerations, market strategies, and local requirements.
.png)
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.
-3.png)
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.
-2.png)
Join Gert Bos at the Global Access 2026 in Galway to discuss international regulatory trends and connect with other QA/RA professionals.
-2.png)
Join the DIA Medical Devices and Drug-Device Combination Products Workshop: Post-Market Surveillance and Clinical Evidence with Bianca Lutters.