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 5 of 25
When a chip vendor's SBOM is enough, when it isn't, and what changes the moment a MedTech team modifies modem, radio, or SoC firmware in the device.
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What the FDA's Feb 2026 guidance expects in interoperability labeling for connected medical devices, and where each element sits in the eSTAR package.
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How to design penetration test cases from a medical device threat model, the methodology that bridges STRIDE-style threats and concrete bench test.
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What the MDS2 / HSCC Manufacturer Disclosure Statement for Medical Device Security covers, what the FDA's Feb 2026 guidance expects in the disclosure.
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What the FDA's Feb 2026 guidance expects in the unresolved cybersecurity anomalies assessment, how to document residual risk, and the deficiency pattern.
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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.
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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.
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What the FDA's Feb 2026 guidance recommends for IDE cybersecurity: informed consent, architecture views, SBOM, labeling, and what's not required yet.
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The real dollar and timeline cost of bolting cybersecurity onto a MedTech device after MVP.
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How to design, isolate, and defend the update channel for connected medical devices - signed manifests, dual-bank A/B, rollback protection, HSM-backed.
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MQTT is one of the most common protocols in IoMT and one of the most commonly misconfigured.
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Class I, II, III doesn't decide your FDA cybersecurity burden. Section 524B's cyber-device test and whether you file a premarket submission do.
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