Deep dives on FDA expectations, threat modeling, penetration testing, SDLC, and the standards your team is being asked to meet.
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 12 of 253 articles · Page 1 of 22
Home use vs hospital device cybersecurity: which controls the HDO environment provides, which the device must carry itself, and how the FDA reviews each case.
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How CVSS scoring works for medical devices, a worked scoring example, and why a raw score is not a patient risk score under FDA guidance.
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How to evaluate healthcare cybersecurity companies by category, the questions to ask, and the evidence an FDA submission actually requires from a vendor.
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Medical device software development explained: design controls, IEC 62304 safety classes, SOUP management, verification, validation, and FDA documentation.
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Security requirements testing verifies your design inputs; penetration testing attacks the built device. What the FDA's Feb 2026 guidance expects for each.
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Embedded Linux vs Windows IoT Enterprise LTSC for medical devices: attack surface, isolation, secure boot, patching, SBOM, and what FDA reviewers actually look at.
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How your Indications for Use statement and predicate choice change the cybersecurity scope of a 510(k): use environment, harm ceiling, pen test scope, and Special 510(k) eligibility.
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Breakthrough Device designation speeds FDA interaction but waives no cybersecurity requirement. Here is how Section 524B applies to Breakthrough devices in 2026.
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Cleared under Section 524B but skipping postmarket cybersecurity? Here's what statute, regs, and FDA enforcement actually say - across 510(k), De Novo, PMA, PDP, and HDE.
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Where FDA premarket cybersecurity artifacts live in an ISO 13485 / QMSR quality system: DHF, risk management file, DMR, and postmarket - clause-by-clause map.
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Cybersecurity for CLIA high-complexity labs: HIPAA, 21 CFR Part 11 data integrity, LIMS hardening, vendor patching, AI/cloud analytics, and CMS/CAP inspection readiness.
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De-identification vs anonymization for medical devices: HIPAA Safe Harbor, GDPR Recital 26, and what the FDA expects for AI/ML training data and postmarket telemetry.
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