Our blogs

Learn the role of a China NMPA Legal Agent, legal requirements, responsibilities, and how Qserve supports medical device market access in China.

A weak regulatory or clinical strategy is the fastest way to lose investor trust in a medtech pitch. Here's what to have ready before your next round.

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.

These are the 5 most common Notified Body findings during CER reviews under MDR — and what you need to address to avoid them.

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 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.