Deep dives on FDA expectations, threat modeling, penetration testing, SDLC, and the standards your team is being asked to meet.
Showing 12 of 271 articles · Page 1 of 23
What the FDA's Feb 3, 2026 guidance expects for penetration test recency, version-match, post-change re-testing, and pre-submission remediation, plus when a delta re-test will do and when you need a full one.
Read article
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 Feb 2026 premarket cybersecurity guidance.
Read article
Which EHR and EMR systems medical devices connect to (Epic, Oracle Health, MEDITECH, Allscripts, athenahealth), the integration protocols (HL7, FHIR, DICOM), and the cybersecurity risks the FDA expects you to document.
Read article
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 submission.
Read article
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 Slots 5, 6, 7, and 8.
Read article
The 8 eSTAR v7.0 cybersecurity slots are identical for IVD and nIVD submissions — but the content reviewers expect is not. The IVD-specific guidance, slot by slot, and the deficiency patterns we see most.
Read article
When the chip vendor's SBOM is enough, when it isn't, and what changes the moment a MedTech team modifies modem, radio, or SoC firmware — with the FDA-aligned evidence package.
Read article
What the FDA's Feb 2026 guidance expects in interoperability labeling for connected medical devices — what content goes in user docs, where it sits in eSTAR v7.0, and how to align with IEEE 11073, HL7 FHIR, and DICOM expectations.
Read article
How to design penetration test cases from a medical device threat model — the methodology that bridges STRIDE-style threats and concrete bench test execution, with traceability the FDA expects in Slot 7.
Read article
What the MDS2 / HSCC Manufacturer Disclosure Statement for Medical Device Security covers, what the FDA's Feb 2026 guidance expects in the disclosure, and where it fits in eSTAR v7.0 labeling.
Read article
What the FDA's Feb 2026 guidance expects in the unresolved cybersecurity anomalies assessment, how to document residual risk, and the deficiency pattern that follows when this section is missing or thin.
Read article
Section 524B(b)(1) makes patchability statutory. What the FDA's Feb 2026 guidance expects in the patch and update mechanism test evidence, the test cases reviewers look for, and the most common deficiency patterns.
Read article30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ FDA submissions.
