Regulatory & Quality
Every finding, with the requirement it maps to.
Audit like a reviewer
Medcrypt's audit scans check your quality documents against requirements and flag what a reviewer would catch, both before and after you file.
Every finding cites the requirement
The report reads like the one the FDA would send, with each finding mapped to the actual requirement so you know exactly what to fix.
Graded against what FDA actually enforces
Scans run on proprietary data about what the FDA is actually catching, rejecting, and requiring, so findings reflect real reviewer behavior, not just what the guidance says.
Post-clearance · Section 524B
Clearance is not the finish line. Section 524B made postmarket cybersecurity a legal duty rather than a best practice, and it is one you stay accountable for every year the device is on the market. Annual reviews, new guidance, and vulnerabilities that surface long after clearance all land back on you. The same scan you ran before filing runs against your current package, so staying compliant is a re-run rather than a rebuild.