Our blogs

ISO 13485 doesn't cover AI-specific risks. See why medical device and IVD manufacturers need a dedicated AI audit to meet EU AI Act and Notified Body expectations.

What ISO 14155 requires for medical device clinical investigations: history, roles, phases, and participant protections, plus how Qserve trains teams on it.

Plan your IVDR performance study with confidence: classification, ISO 20916 design, the submission pathway, and how to select the right IVD CRO.

Discover the learning paths, essential training courses and key skills for Quality Assurance, Regulatory Affairs and Clinical Affairs professionals.

Discover how Qserve supported Jenscare Scientific in achieving EU MDR CE certification for the novel Class III LuX-Valve Plus™ cardiovascular device.

Discover how FDA Predetermined Change Control Plans, PCCPs, enable proactive lifecycle change management and reduce future regulatory submissions.

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.

Qserve Group appoints Inette Nieveen-van de Laar to its Board of Directors, recognizing 11 years of leadership in medical device regulatory affairs.

Catch these five AI compliance gaps under EU MDR & IVDR early. What medtech software teams miss, and where to start fixing it.