Every article in our archive in Penetration Testing.
Looking for a quick answer instead? The FDA medical device cybersecurity FAQ covers Section 524B scope, SBOMs, threat models, CR515 and GMLP, deficiencies, and postmarket duties.
Showing 3 of 3 articles in Penetration Testing
How to design penetration test cases from a medical device threat model, the methodology that bridges STRIDE-style threats and concrete bench test.
Read article
DAST is a subset of FDA-required penetration testing. What the Feb 2026 guidance expects in eSTAR Slot 7, and why a Burp scan alone will fail review.
Read article
What the FDA's Feb 2026 premarket cybersecurity guidance says (and doesn't say) about AI-run penetration testing, where AI helps, where it fails a 524B.
Read article30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ FDA submissions.
