Greenlight Guru Medical Device Blog

Ask a pre-market team where corrective and preventive action (CAPA) sits on the priority list and it usually lands below design controls, risk management, and the submission itself. The reasoning is easy to follow. Nothing has shipped, so there are no complaints...

Most business-case templates for a quality management system (QMS) assume the company has already decided it needs one. They compare vendor pricing against the cost of the system being replaced, factor in hours saved, and produce a payback period. A pre-marke...

Growing medical device companies build large document libraries fast. Hundreds of standard operating procedures (SOPs), work instructions, drawings, and forms, all needing a place to live. Teams naturally group that work by department, by process, or by product...

When a quality management system (QMS) runs on spreadsheets, a traceability matrix is only as current as the last time someone updated it by hand. That may work for a single review cycle, but it doesn't survive a software as a medical...

Supplier issues are among the most common findings in Food and Drug Administration (FDA) 483 observations and warning letters. For newly commercialized medtech companies, the risk usually starts small. A company clears its first device with f...