Clinician-led · UK healthcare
Clinical safety and AI assurance for companies selling into the NHS
Assurance AI is a specialist clinical safety and healthcare AI assurance practice. We help digital health and AI companies produce the evidence NHS organisations actually ask for — and stand behind it.
We provide clinical safety and assurance support. We are not a regulator, certification body or statutory auditor.
Product
Intended use and clinical context
Clinical risk
Hazards, controls, oversight
Evidence
Safety case, hazard log, DTAC
NHS readiness
Procurement-ready assurance pack
Clinical risk management
Evidence mapping
Ongoing assurance
The problem
Good products stall on assurance, not on capability
Most digital health companies we meet are not unsafe. They simply cannot yet demonstrate safety in the form an NHS organisation needs to see it.
Procurement stalls on evidence
The pilot goes well, then the trust asks for a hazard log and a safety case and the conversation stops for three months.
Documents exist but do not match the product
Templates were completed once, the product moved on, and nothing reconciles.
No one owns clinical risk
Engineering assumes clinical has it. Clinical assumes the standard is a document exercise.
AI raises questions nobody has answered
Oversight, monitoring and drift are asked about in review, and the answers are improvised.
What we do
Three areas, one discipline
Clinical risk thinking applied consistently — whether the question is a hazard log, a procurement pack or a model that has started to drift.
DCB0129 clinical risk management
Applicability, hazard identification, hazard log, clinical safety case and Clinical Safety Officer arrangements.
Read moreDTAC readiness
Gap assessment across all five domains, a prioritised remediation plan, and evidence prepared for review.
Read moreHealthcare AI assurance
Clinical hazard analysis for AI-enabled products, human oversight design, and post-deployment monitoring.
Read moreWhich one are you?
Suppliers and deploying organisations have different obligations
The two NHS clinical risk management standards sit on opposite sides of the same product. Knowing which applies to you decides what evidence you need to produce.
You build or sell the product
Suppliers — DCB0129
Manufacturers of health IT systems carry the manufacturer's clinical risk management obligations: intended use, hazard identification, a hazard log, controls, and a clinical safety case report that matches the version you are actually shipping — reviewed and signed off by your Clinical Safety Officer.
- Digital health and healthcare AI companies selling into the NHS
- Teams asked for a hazard log or safety case during procurement
- Products facing DTAC as part of a buying process
You deploy the product into care
Deploying organisations — DCB0160
Health organisations deploying or configuring a system carry their own clinical risk management obligations for how it is used in their pathway. The supplier's evidence is an input to that work, never a substitute for it.
- NHS trusts, ICBs, primary care and independent providers
- Organisations adopting AI-enabled or decision-support tools
- Teams configuring a supplied system into a local workflow
How we work
Clinical judgement first, documentation second
Evidence is only useful if it describes what your product really does. We start with the clinical workflow, not the template.
- 01
Discovery
A structured conversation about your product, its intended use and where it sits in the clinical pathway.
- 02
Gap assessment
An honest read of your current evidence against what NHS buyers and assessors expect.
- 03
Remediation
Hands-on production of hazard logs, safety cases and governance artefacts, prioritised by what unblocks you.
- 04
Ongoing assurance
Keeping evidence current as the product, the pathway and the guidance change.
Why Assurance AI
A clinician in the room, not a compliance template
Clinical safety judgements are made by someone who understands what happens at the point of care when a system gets it wrong.
What we will always tell you
- Where guidance is genuinely unsettled, rather than inventing certainty.
- When a question needs a regulatory specialist rather than us.
- When your evidence is not ready, even if the deadline says otherwise.
- What we cannot do: approve, certify or accredit your product.
Free readiness check
See where your assurance evidence stands
A structured check of 32–42 questions across 4–5 short sections covering clinical safety, governance, data protection, oversight and monitoring. You get category scores, red flags and prioritised next steps in a printable report. No sales call required.
Questions