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
- Record completeness
- 72
100, less 12 for each open blocker and 4 for each warning. It measures the record, not the performance of the AI System.
- Blockers
- 2
FDA PCCP guidance
Predetermined change control plan for AI-enabled device software functions
The three required parts of a PCCP in a marketing submission.
0 covered · 0 partial · 6 open
Working a clause
Select a clause on the left. Link the records that carry the traceability, state how they address it, and attest it. A clause is covered once it is attested.
Clauses
Left, the clause list. Right, the clause you are working.
Part 1
Description of modifications
List each specific, planned modification with its individual specification and the reason for it.
Nothing is linked to Part 1. Link the Change record that addresses it and state how.
Other records of this AI System
External Documents
No document is registered against this AI System yet.
Evidence
One reference for this clause. Link evidence already held, or register it here with its location or file.