V&V and Regression Testing for Medical Device Cybersecurity (FDA §524B)

FDA clearance is the beginning of your cybersecurity obligations, not the finish line. Postmarket cybersecurity for medical devices is an active, continuous requirement that most manufacturers underestimate until a problem forces their hand. Most invest significant resources building premarket docum

Receiving an FDA cybersecurity Additional Information Request (AIR) doesn't mean your submission is dead. It means the clock is ticking, and the next move has to be precise. FDA issues these requests when reviewers find specific, documented gaps in your cybersecurity package, and they expect every g

Here's a pattern Blue Goat Cyber sees regularly: a medical device manufacturer arrives at premarket submission with an ISO 27001 certificate in hand, convinced their cybersecurity story is complete. Weeks later, a deficiency letter arrives. The FDA isn't questioning their information security postur

Our 7-phase, FDA-aligned penetration testing methodology - the playbook every engagement follows.

End-to-end §524B premarket package: SPDF, threat model, SBOM, pen test, and eSTAR-ready documentation.