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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
ISO/IEC 42001:2023

AI management system

Clauses and Annex A controls whose traceability can be carried by the records held here.

All standards
0 covered · 0 partial · 17 open
Working a clause
Select a clause on the left. Link the records that already carry the traceability, state how they address it, and attest it. A clause is only covered once someone attests.

Clauses

Left, the clause list. Right, the clause you are working.

6.1.2

AI risk assessment

Open

Define and apply a process that identifies, analyses and evaluates AI risks, and retain the results.

Nothing is linked to 6.1.2. Link the Risk record that addresses it and state how.

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