Safety and compliance
Triage is a clean reimplementation, designed from the start to be certified as a medical device.
Clinical safety by design
Section titled “Clinical safety by design”- A nurse always decides. The engine suggests an acuity. A nurse confirms every score, and any override needs a reason.
- Flags are not a diagnosis. Stroke, sepsis and cardiac flags prompt clinical review.
- Explained, repeatable scoring. The same answers always give the same result, and the answers that raised the acuity are shown.
- Tested releases. Every clinical rule has automated tests, and a pathway release is blocked if any reference case is under-triaged.
- Signed off before going live. The clinical safety officer approves each pathway version.
- Full audit trail. Every step is time-stamped for clinical review.
- Strict data isolation. Every query is scoped to one hospital by the database itself.
Standards
Section titled “Standards”We produce the evidence. You hold the certification.
| Standard | What our team delivers |
|---|---|
| IEC 62304 | Software lifecycle records, requirements traceability, third-party component list |
| ISO 14971 | Software hazard analysis and the mitigations built into the product |
| ISO 13485 | Development process that plugs into your quality management system |
| ISO 27001 | Secure development, access controls, independent penetration test |
| DCB0129 | Technical inputs to your clinical safety case and hazard log |
| EU MDR / UKCA | Software technical documentation for your conformity assessment |
Regulatory evidence is produced as the product is built, not afterwards.