Regulatory tracker · agency
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.
Other agencies in the tracker
Ready when you are
Get FDA cleared without the cybersecurity headaches.
30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ FDA submissions.