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SystemAIS-002Medical device and SaMD

Triage Note Summariser

Summarise free-text triage notes for the reviewing nurse. Non-diagnostic.

Device class
Not a medical device
Status
In development
State
In progress
Owner
Cirocco Jones
Readiness
72
Blockers
2

Monitoring does not stop when an AI System is approved. A signal opens a finding, and a breach can place the AI System under restriction before anyone opens a form.

Scout is watching
Nothing open. Every signal raised has been acknowledged and answered.

Open signals

Ordered as received. Nothing closes itself.

ObservedTypeSignalSeverity

No open signals.

Answered

Kept, because the response is part of the record.

ObservedTypeSignal

Nothing answered yet.