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

Identity

What the system is, where it is placed, and how often it is reviewed.

Description

Internal application. Registration complete, development authorisation open.

Markets

European Union

Sectoral class

Not a medical device

FDA position

Not assessed

EU AI Act tier

Not assessed

QMS reference

QMS-DHF-2410

Deployed configuration

Not recorded

Placed on market

Internal reviews

12 months, none recorded yet Open AI Reviews

Lifecycle

Where the system stands, and the act that moves it on. Every move is written to the audit trail under the acting persona.

Registered

The system exists as a record. Design work has not started.

In development

Design and development are under way. Nothing is in use outside the project.

Approved for operation

Released for use. The post-market duties apply from this point.

Under restriction

In use, but with a limitation placed on it after a signal or a finding.

Suspended

Use is stopped while a matter is settled.

Retired

Withdrawn from use. Records are held for the retention period.

Move to

Rationale

Linked records

Navigate from the AI System to every governed record.

Planned Modifications

Chronology

Every dated act on this AI System and its records, in order.

2026-04-02SystemAIS-002AI System registered

Governance gates

A gate is held until it is proven. It passes when the records it depends on exist, an approved AI Review of the matching type is recorded, and no blocker in its scope is open.

Gate	Purpose	Responsible	Outcome	What is missing
Development authorisation	Authorises development against a stated intended purpose.	Independent Reviewer	Held	No AI Use Case is recorded, so there is nothing to authorise development against. Record a use case No approved AI Review of type Development authorisation. Open the review CLASS-01 AI System is not classified
Model approval	Approves an immutable AI Model Version for use.	Independent Reviewer	Held	No AI Model Version exists, so there is nothing to approve. Record a model version No Dataset Version is linked to a model version for training. Link a dataset No approved AI Review of type Model approval. Open the review
System approval for operation	Approves the complete AI System for operation in a market.	Independent Reviewer	Held	No AI Risk is recorded, so the risk position is unstated. Record a risk No AI Use Case is approved. Open the use cases No approved AI Review of type System approval for operation. Open the review REV-02 No periodic review recorded CLASS-01 AI System is not classified
Change authorisation	Authorises a change inside the Controlled Evolution boundaries.	Quality and Regulatory	Held	No Controlled Evolution boundary is recorded for this AI System. Record the boundary No Planned Modification has been assessed. Open controlled evolution No approved AI Review of type Change authorisation. Open the review
Resumption	Resumes operation after restriction or suspension.	Independent Reviewer	Held	The AI System is not restricted or suspended, so there is nothing to resume. Open the AI System No approved AI Review of type Resumption. Open the review

Posture summary

Compliance posture narrative

A written summary of the computed findings and the recommended order of work. The findings themselves are deterministic. The narrative never states that the AI System is compliant.

Demonstration fill

Generate the rest of the record set

Scout drafts AI Use Cases, AI Models and versions, Datasets and versions, the dataset to model links, AI Risks, AI Reviews and Planned Modifications, all consistent with what this AI System already states. Records are added as drafts and every one carries an audit entry saying it was generated.

Open findings

2 blockers, 1 warnings.

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
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

Monitoring

Signals observed on the deployed configuration.

Metric	Observed	Threshold	State	Observed on

Framework mappings

A mapping records where a requirement is addressed. It does not assert compliance.

No framework mappings are recorded for this AI System.

Audit trail

2026-04-02Cirocco JonesRegistered AI System