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Have non-EU clinical data? Learn what EU MDR actually requires for CE certification, and how to turn existing evidence into a defensible route to market.

PPWR compliance starts in August 2026. Learn what medical device manufacturers need to do now to prepare packaging documentation and declarations.

Get to know Mike Szymonik, Software, AI and IVDR expert at Qserve. With ample experience, he ensures compliance and supports Notified Body engagement.

Join Oliver Schaer and Bingshuo Li on 21-23 April at DMEA 2026 in Berlin and explore practical insights on Digital Health.

Join industry leaders, regulatory professionals and Qserve Expert Gert Bos at MedCon 2026 in Columbus, Ohio on Apil 22-24.

The transition to IVDR is entering its final phase, and the clock is ticking for Class C IVD manufacturers, as Notified Body assessment is now required.