Our blogs

The transition to IVDR is entering its final phase, and the clock is ticking for Class C IVD manufacturers. Under the IVDR, Class C devices now require assessment by a notified body.

Join Gert Bos and Bingshuo Li at TOPRA Symposium 2026 and explore practical insights on improving EU MDR and shaping its future.

Learn about the roles, responsibilities and legal requirements of a U.S. FDA Agent. Expect to read about compliance implications and common misconceptions.

Companies that import or distribute medical devices in Canada must obtain a Medical Device Establishment Licence (MDEL).

Learn where Medical Device Start-Ups go wrong and how to avoid these pitfalls.

Learn about the UKRP appointment and registration process, the importance of proper documentation, and manufacturers' obligations from a UKRP perspective.

Discover how Regulatory Intelligence platforms save time, reduce errors, and turn compliance into a strategic advantage for medical device and IVD companies.

Clinical data quality drives every study decision. Learn how Qserve handles structured data management and thorough UAT to prevent delays and surprises.

Meet Qserve at DIA Europe 2026, Track 6, as Gert Bos discusses innovation and competitiveness in European medical devices and combination products.