Greenlight Guru Medical Device Blog

Most software device teams I work with assume audits follow a predictable rhythm. Show the CAPA. Walk through the DHF. Demonstrate the quality system is in order. Under the old QSR, that assumption was mostly correct, but after...

If you are selling a medical device in the European Union, the clinical evaluation report (CER) is one of the most scrutinized documents in your technical file. Notified Bodies assess it at every certification and renewal cycle. It has to sa...

Medical device teams are under more pressure than ever. Timelines are tighter, regulatory expectations are higher, and AI tools are multiplying faster than anyone can evaluate them. In that environment, it would be easy to ship features with...

Software is transforming the medical device industry, and the rules that govern it haven't always kept pace. Apps that update weekly, cloud-based platforms that evolve in real time, and AI-driven diagnostics have all arrived ...

I work with SaMD teams every day. Most of them know the regulatory landscape is shifting around AI. Fewer have actually read the guidance documents. And almost none have thought through how a predetermined change control plan (PCCP) would ...