Every article in our archive tagged SPDF.
A Secure Product Development Framework (SPDF) is the set of processes a manufacturer uses to build security into a device across its whole lifecycle, from requirements and design through testing, release and postmarket maintenance. The FDA's premarket guidance asks manufacturers to show that their device was developed under one.
An SPDF is not a separate system. It works best folded into your quality system and software lifecycle. The articles below cover mapping it to IEC 62304, adding security gates to CI/CD pipelines, integrating deliverables into ISO 13485 and the QMSR, and documenting it for reviewers.
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 6 of 6 articles tagged SPDF
Where FDA premarket cybersecurity artifacts live in an ISO 13485 / QMSR quality system: DHF, risk management file, DMR, and postmarket - clause-by-clause map.
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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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How to document update cadence for an FDA §524B submission: the regular cycle and the out-of-cycle expedited path reviewers expect under §524B(b)(2)(B).
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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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What the FDA's Feb 3, 2026 final premarket cybersecurity guidance expects from a medical device incident response plan, who owns it, and the documents.
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FDA cybersecurity documentation requirements (2026): SPDF artifacts, Section 524B evidence, SBOM, threat model, testing, and labeling reviewers expect.
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