DocumentDOC-001
AI management system manual
- Reference
- QMS-AIMS-MAN-001
- Type
- Manual
- Version
- 3.0
- Effective
- 2025-06-01
- Held at
- aims-manual-v3.pdf
- Clauses
- 1
Scope, context and management commitment of the AI management system.
SystemAIS-001Medical device and SaMD
Retinal Screening Assistant
Support ophthalmology screening services by detecting referable diabetic retinopathy in colour fundus images and prioritising cases for specialist review.
Device class
Class IIa (MDR)
FDA
Class II, 510(k)
EU AI Act
High-risk (Annex I)
- Status
- Approved for operation
- State
- Deployed
- Owner
- Cirocco Jones
- Readiness
- 0
- Blockers
- 12
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Documents held here
3 documents registered against this AI System.
Registered documents
Ordered as registered.
DocumentDOC-002
Data governance procedure
- Reference
- QMS-DAT-PRO-014
- Type
- Procedure
- Version
- 2.1
- Effective
- 2024-09-18
- Held at
- data-governance-procedure.pdf
- Clauses
- 1
Acquisition, labelling, provenance and retention of training and test data.
DocumentDOC-003
Post-market surveillance plan
- Reference
- DHF-2291-PMS-001
- Type
- Plan
- Version
- 1.4
- Effective
- 2025-11-12
- Held at
- pms-plan.pdf
- Clauses
- 0
Monitoring of field performance, complaints and drift after release.
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