Every article in our archive tagged Primer.
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 121 articles tagged Primer · Page 1 of 11
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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You're two years into product development and still "not ready" for cybersecurity? You're already late.
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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.
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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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The 2026 FDA premarket cybersecurity submission checklist: the six Section 524B deliverables reviewers score on 510(k), De Novo, and PMA filings.
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SPDF vs SSDLC for medical devices. Why the FDA's Secure Product Development Framework demands more than a standard Secure SDLC, and what to add.
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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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MQTT is one of the most common protocols in IoMT and one of the most commonly misconfigured.
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How to build FDA-defensible fuzz harnesses for the protocols medical devices actually speak.
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How to operationalize SBOM diffing and CVE correlation across releases so postmarket vulnerability monitoring holds up under FDA Section 524B and the Feb.
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