Clinical safety
Safe by design.
Validated in practice.
Brave AI is a UKCA Class I regulated medical device, developed and deployed in compliance with NHS clinical safety, data security, and interoperability standards.
Award winner
HSJ Digital Clinical Safety Award 2026
Brave AI was recognised by the Health Service Journal for excellence in digital clinical safety — the leading independent recognition of safe, effective health technology in the NHS.
Deployment pathway
From data to clinically live
Every Brave AI deployment follows a structured five-stage process to ensure clinical safety before any patient data is reviewed.
Regulatory framework
Built to NHS standards
Brave AI is developed and maintained under a comprehensive clinical safety and quality management framework, meeting all requirements for deployment within NHS organisations.
Clinical Risk Management — Manufacturer
Bering Limited has produced and maintains a Clinical Safety Case Report, Hazard Log, and Risk Management Plan in full compliance with DCB0129. The system has been assessed as safe to deploy across NHS Digital Neighbourhood Programmes.
Clinical Risk Management — Deployment
Deploying organisations receive comprehensive Instructions for Use, deployment checklists, and support for producing local Standard Operating Procedures in compliance with DCB0160.
Medical Device Risk Management
Risk analysis is conducted using Failure Mode and Effect Analysis (FMEA) in accordance with ISO 14971:2019. All identified hazards have been assessed and controlled to an acceptable residual risk level.
Quality Management System
Bering Limited operates a quality management system conforming to ISO 13485 for the design, development, and post-market surveillance of Brave AI as a medical device.
UK Medical Device Regulation
Brave AI is registered as a UKCA Class I medical device under UK MDR 2002, Rule 12. The device classification reflects its role as clinical decision support software, not a diagnostic device acting alone.
NHS Digital Standards
Brave AI meets the NHS Digital Technology Assessment Criteria (DTAC) and the Data Security and Protection Toolkit (DSPT), covering clinical safety, data protection, technical security, interoperability, and usability.
Risk management
Hazard assessment and residual risk
All hazards identified under the DCB0129 Clinical Safety Case Report have been assessed, controlled, and documented in the Brave AI Hazard Log.
Nature of hazards
All identified hazards relate to either missed or delayed implementation of proactive interventions, or unnecessary implementation of proactive interventions. Neither introduces new clinical risk — they represent changes to existing care pathways only.
Residual risk
Following implementation of all risk controls, all hazards have been assessed at probability level 1 (Negligible). Brave AI is classified as a low-risk medical device. No high or medium residual risks remain in the hazard log.
Clinical judgement preserved
Brave AI is a decision support tool. All clinical decisions remain with qualified healthcare professionals. The software surfaces information to support — not replace — the clinical judgement of GPs, nurses, and MDT members.
Continuous surveillance
Post-market surveillance is an ongoing activity. Bering Limited monitors performance across all deployed sites and updates the hazard log, risk assessment, and clinical safety documentation in response to any new evidence or operational findings.
Data safety
Patient data never leaves the NHS
Brave AI is designed from the ground up to operate within the NHS security boundary. Patient data is processed in place — it is never transmitted to Bering Limited's systems.
Request our clinical safety documentation
For procurement, DTAC assessments, or clinical governance purposes, we can provide our full Clinical Safety Case Report, Hazard Log, Instructions for Use, and Data Processing Agreement on request.