DCB0129 — Manufacturer Safety
DCB0129 clinical safety, done properly
The clinical safety case and hazard log NHS buyers expect from a health-IT manufacturer — produced efficiently and ready for audit.
What you receive
A complete DCB0129 pack
- Clinical safety case report
- Hazard log
- Hazard workshop facilitation
- CSO process support
- Intended-use & risk statement
- Audit-ready documentation
Deploying into an NHS organisation as well? You'll also need DCB0160 deployment safety.
Why it matters
Clinical safety is a gate, not a formality
DCB0129 is the information standard that manufacturers of health IT used in patient care in England must meet. It requires a clinical safety case report and a hazard log, owned by a named, suitably qualified Clinical Safety Officer, demonstrating that the clinical risks your product could introduce have been identified, assessed and controlled. For a growing number of NHS buyers it is a hard gate: no credible safety case, no procurement. Treated well, it is also genuinely useful — it forces clarity about intended use, surfaces design risks early, and gives your clinical and commercial teams a shared, defensible account of how the product behaves.
How we produce your safety case
- Intended use and scope. Pin down exactly what the product does, for whom, in what setting, and the clinical claims behind it — the foundation everything else rests on.
- Hazard workshops. Structured sessions with your clinical and engineering teams to identify hazards, causes and clinical consequences across the product lifecycle.
- Risk assessment and control. Score each hazard, define and verify mitigations, and record residual risk and acceptance in the hazard log.
- Safety case report. Assemble an audit-ready Clinical Safety Case Report and a maintenance plan so the evidence stays current as the product evolves.
Common pitfalls we help you avoid
- Leaving it until procurement — discovering you need a safety case mid-deal, with no time to do it properly.
- A vague intended-use statement — the single most common reason a safety case fails to convince.
- A static document — a safety case that no longer matches the shipped product undermines trust.
- Ignoring AI-specific risk — performance drift, bias and over-reliance belong in the hazard log, not a separate afterthought.
Answers
Frequently asked questions
Who needs DCB0129?
Manufacturers of health IT systems used in patient care in England — including AI tools. It requires a clinical safety case report and hazard log, owned by a named Clinical Safety Officer. See DCB0129 vs DCB0160.
What do you deliver?
We produce or review your clinical safety case and hazard log, support hazard workshops, and help you stand up a compliant, audit-ready clinical risk management process.
Can you act as our Clinical Safety Officer?
We support and mentor the CSO function and produce the artefacts; the accountable CSO role remains within your organisation.
When in development should we start DCB0129?
As early as possible. Treating clinical safety as a late, pre-sales paperwork exercise is the most common and most expensive mistake — hazards that should have shaped design get discovered at procurement. Starting at the design stage lets safety requirements inform the product and keeps the safety case a living document rather than a retrofit.
Does DCB0129 apply to AI and machine-learning products?
Yes. AI health-IT used in patient care in England is in scope, and attracts extra scrutiny around performance, change management and transparency. We fold AI-specific hazards — drift, bias, automation bias and the conditions for safe human oversight — into the hazard log. See Bias, Safety & Human Factors.
How does this help us sell to the NHS?
A credible DCB0129 safety case is a gateway to NHS procurement and a core part of buyer readiness alongside the DSP Toolkit, DTAC and a DPIA. Buyers increasingly ask for it up front, so having it ready shortens sales cycles.
Need a DCB0129 safety case?
Bring your product and we'll scope the clinical safety artefacts.