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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

Findings are computed from record state on every read, evaluated on 2026-07-30. Nothing here is stored on a record.

Where this AI System stands
2 blockers hold this AI System back. Each names the record and the action that clears it.

Blockers

A blocker stops a governance gate from passing.

  • BlockerREV-02No periodic review recorded

    The AI System has never been reviewed.

    Affects
    AIS-002
    Effect
    Blocks continued operation.
    Plan a periodic review
  • BlockerCLASS-01AI System is not classified

    No device class is recorded, so the applicable obligations are undetermined.

    Affects
    AIS-002
    Effect
    No governance gate can pass and no profile rule can be evaluated.
    Run the classifier

Warnings

A warning lowers readiness but does not stop a gate.

  • WarningCE-03No Controlled Evolution declared

    Permitted change is undefined, so every change needs a new authorisation.

    Affects
    AIS-002
    Effect
    No PCCP can be generated.
    Declare Controlled Evolution

For information

Recorded so nothing is silently dropped.

No findings. Every rule in scope passes.

Nothing to note.