Deep dives on FDA expectations, threat modeling, penetration testing, SDLC, and the standards your team is being asked to meet.
Showing 12 of 282 articles · Page 1 of 24
You're two years into product development and still "not ready" for cybersecurity? You're already late. When to start medical device cybersecurity, by phase.
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A phase-by-phase mapping of the FDA's SPDF onto IEC 81001-5-1 activities, so dual FDA + EU submissions produce one artifact set instead of two.
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IEC 62304 governs the software lifecycle. IEC 81001-5-1 adds security activities on top. Here's what each covers, where they overlap, and how they combine for the FDA and EU.
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JSP2 is a development framework, MDS2 is a procurement disclosure form. Here's how the two artifacts complement each other across the device lifecycle.
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The FDA lists JSP2, SPDF, IEC 81001-5-1, and ISA/IEC 62443-4-1 as acceptable cybersecurity frameworks. Here's how to actually pick one for your submission.
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Choosing between MedCrypt, Finite State, and Blue Goat Cyber? Compare SBOM tools, vulnerability management, and FDA-required pen testing for your medical device
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The premarket FDA cybersecurity submission checklist medical device teams use to pass 510(k) and PMA review under Section 524B and the 2026 guidance.
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The FDA's Feb 3, 2026 guidance names 7 AI cyber threats, data poisoning, model inversion, evasion, leakage, overfitting, bias, drift, as 524B obligations.
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Section 524B applies to a connected auto-injector when the device constituent has software and any electronic interface, regardless of whether CDER or CDRH leads review.
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How de-identification and anonymization differ for medical device data under HIPAA Safe Harbor, Expert Determination, GDPR, and FDA AI/ML expectations — and where teams get it wrong.
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How Threat Analysis and Risk Assessment (TARA) fits FDA premarket cybersecurity, AAMI TIR57, and ISO 14971 for medical device manufacturers in 2026.
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How to run a design FMEA (dFMEA) for a connected medical device, link it to the ISO 14971 risk file, and hand off cyber-triggered failure modes to the threat model the FDA expects.
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