Greenlight Guru Medical Device Blog

Getting your device to market can feel like crossing the finish line. Your team has spent months, if not years, building toward a submission. And once the clearance or approval arrives from the Food and Drug Administration (FDA),...

Most medtech companies have more quality data than they can act on. Complaints pile up, Corrective and Preventive Actions (CAPAs) sit in backlogs, nonconformances (NCs) get resolved in isolation. Field data flows into the quality manag...

A scalpel has not changed meaningfully since before I went to medical school. The same cannot be said for any software product I have ever worked on.

I spent 12 years as a medical officer at FDA's Center for Devices and Radiological Health. Before that, I was a cardiothoracic surgeon for 25 years. And in all that time, the question I hear most often from software device companies st...