Every article in our archive in Pen 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 7 of 7 articles in Pen Testing
What an FDA pen test must include and how recent it must be under the Feb 3, 2026 guidance: version match, re-testing after changes, and fixing findings before you file.
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How to build FDA-defensible fuzz harnesses for the protocols medical devices actually speak.
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Illustrative BLE/RF penetration-testing scenarios for a connected Class II medical device. Aligned with the FDA's Feb 3, 2026 premarket cybersecurity.
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When penetration test reports are vague, incomplete, or written to enterprise IT standards rather than medical device requirements, FDA reviewers issue.
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Ensure medical device safety with robustness and fuzz testing. Uncover critical vulnerabilities and maintain performance under diverse conditions.
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How to scope a medical device penetration test the FDA will accept: interfaces to include, what to provide the tester, and why a narrow scope costs review time.
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Medical device penetration testing post exploitation covers pivoting, persistence, exfiltration paths, safety controls, and report evidence reviewers expect.
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