Deep dives on FDA expectations, threat modeling, penetration testing, SDLC, and the standards your team is being asked to meet.
Showing 12 of 292 articles · Page 4 of 25
What the FDA's Feb 3, 2026 guidance expects for penetration test recency, version-match, post-change re-testing, and pre-submission remediation, plus.
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When HIPAA applies to medical device manufacturers, how the 2025 Security Rule NPRM raises the bar, and how HIPAA obligations intersect with the FDA's.
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Which EHR and EMR systems medical devices connect to (Epic, Oracle Health, MEDITECH, Allscripts, athenahealth), the integration protocols (HL7, FHIR.
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What the CISA Known Exploited Vulnerabilities (KEV) catalog is, how medical device manufacturers should use it in SBOM/VEX triage, and how the FDA treats.
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How Health Canada regulates medical device cybersecurity in 2026: device and IVDD classification, licence evidence routes, MDSAP reliance, and Section 59 reporting.
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What the FDA expects from infusion pump cybersecurity submissions in 2026: threat model focus areas, Section 524B evidence, and the deficiencies that.
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What the FDA's Feb 3, 2026 final premarket cybersecurity guidance expects from a medical device incident response plan, who owns it, and the documents.
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How the TGA regulates medical device cybersecurity in 2026: Essential Principles 12 and 12A, the TGA cyber security guidance v1.2, and reusing an FDA 524B package.
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IEC 62304 software safety classes (A/B/C) and FDA device classes (I/II/III) are not equivalent.
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What a DFD is, the five DFD elements, and how data flow diagrams feed STRIDE threat modeling and the FDA's Security Architecture Views in a 2026.
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Where containers appear in medical devices, the testing the FDA expects under the Feb 3, 2026 guidance, and how container evidence maps to eSTAR v7.0.
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eSTAR v7.0 cybersecurity slots are identical for IVD and nIVD submissions, but the content reviewers expect is not. Here's how to fill each section correctly.
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