CEP and CER are not the same document. Learn the critical difference between a Clinical Evaluation Plan and Report under EU MDR, and why it matters.
.png)
Discover how Qserve supported Jenscare Scientific in achieving EU MDR CE certification for the novel Class III LuX-Valve Plus™ cardiovascular device.
-3.png)
Discover the 5 top reasons Clinical Evaluation Reports fail MDR review, and what your team must do to get it right the first time.
-2.png)
Join Oliver Schaer and Bingshuo Li on 21-23 April at DMEA 2026 in Berlin and explore practical insights on Digital Health.
-2.png)
Join industry leaders, regulatory professionals and Qserve Expert Gert Bos at MedCon 2026 in Columbus, Ohio on Apil 22-24.
-1.png)
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.