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AAMI Medical Device Cybersecurity Updates

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AAMI medical device cybersecurity updates

Association for the Advancement of Medical Instrumentation

AAMI consensus standards - TIR57, TIR97, SW96 and related - that the FDA references for medical device cybersecurity risk management.

1 tracked changeLast reviewed Oct 5, 2026 RSS

Mar 31, 2026·Standards draftDraftMedium impact
ANSI/AAMI SW96 Amendment 1 draft circulated for member review
Draft amendment clarifies threat modeling traceability, security risk evaluation, and the relationship between SW96 and AAMI TIR57.
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Full-Service FDA Premarket Cybersecurity
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Medical Device Threat Modeling
Medical Device Penetration Testing
FDA Postmarket Cybersecurity
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MedTech Cybersecurity · Since 2022