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
Coverage records where a requirement is addressed by the records this AI System already holds. It does not state that the AI System is compliant.
What to monitor
2 standards monitored, 23 clauses with nothing linked.
Standards
Select the standards this AI System is monitored against. Only the selected ones are assessed.
ISO/IEC 42001:2023
AI management system
Clauses and Annex A controls whose traceability can be carried by the records held here.
ISO/IEC 23894:2023
Guidance on AI risk management
The risk management process, traced to AI Risks and the reviews that accept them.
ISO/IEC 23053:2022
Framework for AI systems using machine learning
The machine learning pipeline, traced to datasets, model versions and monitoring.
EN 18286:2026
Quality management system for EU AI Act regulatory purposes
AI system realization, operations and change clauses that the records can evidence.