Evidence Pack
DCB0129 · version 1.4
Signed by clinical safety officer12 of 12 hazards traced
DCB0129 clinical safety
A signed clinical safety case, built from real testing.
Your NHS buyer will ask for a signed safety case. We produce it: the hazard log, the Clinical Safety Case Report and our in-house CSO's signature, with every control backed by a test on your real product.
Illustration. Example values from a fictional project, not a client engagement.
What this route is for
Can you show how clinical hazards were identified, how risks were managed, and what evidence supports the controls?
DCB0129 is the NHS England standard for clinical risk management in the manufacture of health IT. It asks you to answer that question with evidence, for every release.
We produce that evidence from testing your real product, and our Clinical Safety Officer signs the safety case. We do not certify or approve the product.
From risk to proof
Every hazard ends in a test result.
Each hazard is linked to the control that manages it, the test that proves the control works, and the build it was tested on.
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Clinical context and hazards
We map who uses your product, in which clinical workflows, and what could go wrong for a patient.
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Controls and requirements
For each hazard, we record the control that manages it and the requirement that describes it.
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Risk-mapped testing
We test every control on your real product, under the conditions that matter clinically.
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Traceability
Every result is tied to its hazard, its control and the software version, including defects and re-tests.
What you receive
The DCB0129 Evidence Pack, signed by our Clinical Safety Officer.
A two-week Sprint builds the foundation for the highest-risk area of your product. The complete pack, including the signed Clinical Safety Case Report, typically follows four weeks later.
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Clinical Risk Management Plan
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Hazard Log, populated and maintained
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Clinical risk assessment, with initial and residual risk
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Risk-control verification, every control linked to a test
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Risk-mapped test records, with recordings and screenshots
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Defect, change and re-test trail
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Clinical Safety Case Report
Signed by our in-house CSO -
CSO sign-off record
The signature, on record -
Traceability matrix, from hazard to released version
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Release safety summary
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Evidence index and handover pack
Who does what
Clear roles, agreed before the Sprint starts.
We run the testing and produce the pack. Our Clinical Safety Officer makes the clinical judgements and signs. Your team gives us the access and input only you can.
| We do | Our Clinical Safety Officer | Your team provides |
|---|---|---|
| Scope and intended use, agreed with you | Evaluates each risk and whether it is acceptable | Clinical and product people for the hazard workshops |
| Hazard workshops and the Hazard Log | Triages every defect for clinical impact | Access to the build and test environment |
| Risk controls, each linked to a test we run | Reviews and signs the Clinical Safety Case Report | Fixes for the defects we find |
| The Clinical Risk Management Plan and safety case, drafted | Carries out the release safety review | The accountable signatory for the release decision |
| A handover pack for your NHS customer's own clinical safety assessment | Running the incident process after go-live |
AI Test Group is not a notified body. We do not certify or approve anything, and we do not determine whether a product is a medical device. The manufacturer's accountable signatory signs the release decision.
Common questions
Practical questions before the evidence work begins.
What is the difference between DCB0129 and DCB0160?
DCB0129 applies clinical risk management in the manufacture of Health IT systems. DCB0160 applies clinical risk management in the deployment and use of Health IT systems by health and care organisations. They are related standards with different accountable organisations.
Who is DCB0129 for?
It is the NHS England information standard for applying clinical risk management in the manufacture of Health IT systems used in health and care. It is designed to help manufacturers evidence clinical safety.
Is DCB0129 a product certificate?
No. It is a clinical-risk-management information standard. Evidence work is not a certificate, procurement guarantee, or product approval.
What role does the Clinical Safety Officer play?
Clinical safety leadership is part of the managed service where it is in scope. The manufacturer remains accountable for its product and the appropriate accountable signatory signs the safety case.
Can you start with our existing Hazard Log and testing?
Yes. We map what is useful, establish gaps and assumptions, and scope the evidence work around the product version and clinical-risk-management question in front of you.
Can the evidence support NHS procurement or DTAC work?
A structured clinical-safety evidence record can support the questions raised in procurement and assurance activity. The exact deliverable is agreed around your product and review route.
What happens when the product changes?
Continuous Coverage can be scoped to keep risk, testing, and evidence current as releases, defects, risk controls, and clinical workflows change.
A defined next step
Start with a Compliance Sprint, finish with a signed pack.
Typically 2 weeks · fixed scope
Compliance Sprint
One release and the area of your product with the most clinical risk. You end with an evidence foundation and a costed route to the signed pack.
Typically 4 weeks after the Sprint
Pack completion
The remaining hazards, controls, tests and documents. You end with the full DCB0129 Evidence Pack, signed by our Clinical Safety Officer.
Every release after that
Continuous Coverage
Each release re-tested and the pack re-issued, so your safety case stays current instead of ageing.
Timings assume access to your product and test environment, input from your team when we need it, and fixes landing within the window.
Bring the product and the question in front of you.
Book a 20-minute scoping call. We'll look at your product and the evidence you already have, and come back with a proposal within one working day.