Standards· Jul 21, 2026
AAMI SW96 vs TIR57: Did SW96 Replace It?
AAMI SW96 didn't formally replace TIR57, but SW96 is now the FDA-recognized normative standard. Here's what changed and what the FDA expects in 2026.
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AAMI SW96 articles.
Every article in our archive tagged AAMI SW96.
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Showing 3 of 3 articles tagged AAMI SW96
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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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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