Why Gap Analysis Fails Three reasons companies stall after identifying gaps: Wrong priorities. They start with documentation cleanup when risk management is the real issue. QMSR changed the emphasis. If you're fixing the wrong things first, you're wasting time.

What happens when you pair practical FDA expertise with next-gen AI? You stop checking boxes and start building culture. For the last two decades, the Medical Device industry has been stuck in a loop. Startups are terrified of the FDA. Scale-ups are drowning in paperwork. And when an audit notice