Clinical safety
Safety is a product feature, not a paperwork exercise.
Neriant ships with a built-in safety case workspace aligned to NHS DCB0129 (manufacturer) and DCB0160 (deploying organisation). Hazards, mitigations and evidence are produced alongside the code — not assembled before an audit.
Lifecycle
How safety is engineered in.
Hazard identification
Workflow-level hazard analysis for every clinical module — orders, medications, results, handovers, alerts. Hazards are entered into a structured log linked to the affected service.
Risk evaluation
Each hazard is scored for likelihood and severity using a published matrix. Mitigations are tracked to the controls (technical, process, training) that close them.
Mitigation & controls
Mitigations are linked to code, configuration, training material or operational procedure. Residual risk is recorded and approved by the clinical safety officer.
Evidence & sign-off
The hazard log, safety case report and release notes are produced per release. Deploying organisations layer DCB0160 artefacts on top using the same workspace.
Evidence
What you get out of the platform.
Standard artefacts are generated per release and per deployment, ready for clinical safety officers, trust governance and regulators.
- Clinical Safety Case Report (DCB0129)
- Hazard Log with mitigations and residual risk
- Clinical Risk Management Plan
- Release-aligned safety evidence pack
- DCB0160 deployment artefacts template for trusts
- Change-impact analysis for each clinical release
Scope
Beyond the NHS.
The DCB0129/DCB0160 workspace is used as-is for UK NHS deployments. The same hazard log, risk management plan and evidence pack format adapts to ISO 14971 medical-device risk management, EU MDR/IVDR obligations, and equivalent regulatory regimes in USA and emerging-market deployments.