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 TIR57 articles.
Every article in our archive tagged AAMI TIR57.
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Showing 3 of 3 articles tagged AAMI TIR57
Risk Management· Jun 25, 2026
Design FMEA for Medical Devices: dFMEA
How to run a design FMEA (dFMEA) for a connected medical device, link it to the ISO 14971 risk file, and hand cyber failure modes to the threat model.
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Risk Management· Jun 18, 2026
FMEA vs Threat Modeling for Medical Devices
FMEA covers random and systematic failure modes; threat modeling covers adversarial action.
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