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 103 articles tagged Primer · Page 1 of 9
What is MedTech, and how does it differ from a medical device or life sciences? Clear definitions, from scalpels and sutures to connected cyber devices.
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What the FDA actually wrote in cybersecurity Additional Information letters: eight recurring deficiencies ranked by frequency, root causes, and the artifact that closes each.
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How CVSS scoring works for medical devices, a worked scoring example, and why a raw score is not a patient risk score under FDA guidance.
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Medical device software development explained: design controls, IEC 62304 safety classes, SOUP management, verification, validation, and FDA documentation.
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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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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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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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