SPDF· Jun 25, 2026
CI/CD Security Gates for Medical Devices
How to wire SAST, SBOM, secrets, container, and signature gates into a medical-device CI/CD pipeline so the SPDF produces the evidence FDA reviewers.
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IEC 62304 articles.
Every article in our archive tagged IEC 62304.
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.
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Showing 3 of 3 articles tagged IEC 62304
FDA· Jun 18, 2026
SPDF and IEC 62304 Mapping: FDA Cyber
How SPDF activities map to IEC 62304 software lifecycle processes - the exact crosswalk FDA reviewers expect, where they overlap, and where 62304 falls.
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Compliance· Jun 12, 2026
IEC 62304 Classes vs FDA Device Classes
IEC 62304 software safety classes (A/B/C) and FDA device classes (I/II/III) are not equivalent.
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