THE PROBLEM
Of submissions reviewed by a qualified clinician before sign-off
What's included
The problem with clinical safety done as an afterthought
DCB0129 is the NHS clinical risk management standard for health IT systems. DCB0160 covers clinical risk management for health IT deployment. Together they form the clinical safety backbone of any NHS-facing digital health product — and both require documentation that is thorough, evidence-based, and signed off by a qualified Clinical Safety Officer.
Most teams treat clinical safety as a box to tick at the end of development. The result is hazard logs that are incomplete, safety cases that lack clinical rationale, and submissions that fail review — sometimes repeatedly. A poorly constructed safety case does not just delay procurement. It signals to commissioners that the product was not built with patient safety at its centre.
Deliverables
What's included
Strategy
Suitable for new builds, updates, and existing products
- Product scope and intended use review
- Clinical context mapping
- Hazard identification workshop
Build
Full clinical safety documentation constructed to DCB0129 and DCB0160 standard.
- Hazard log creation and risk scoring
- Clinical safety case document
- Residual risk assessment and mitigation plan
Handoff
Formal clinical sign-off and submission-ready documentation package.
- Independent clinical safety review
- CSO sign-off and certification
- Submission-ready documentation pack
Support
Ongoing clinical safety management for product updates and audits.
- Safety case update for new releases
- Audit cycle and review support
- Procurement and due diligence responses
How we work
A process built for results
Clear milestones, clinician-led accountability, and zero ambiguity. Here’s how we get from intake to signed safety case.
Discovery & Success Criteria
We review your product architecture, clinical context, intended use, and patient-facing touchpoints to establish the full safety scope
Hazard Identification & Risk Assessment
We run a structured hazard identification process, score each risk against the clinical risk matrix, and define mitigation strategies
Documentation Build
We build your complete hazard log, clinical safety case, and all supporting evidence to DCB0129 and DCB0160 standard
Review + Sign-off + Handoff
Independent clinical review, gap resolution, formal CSO sign-off, and handoff of your complete submission-ready package
Clinical safety examples
See what's possible
New Product Safety Case
- Signed safety case. Procurement unlocked.
Post-Release Safety Update
- Safety case current. Compliance maintained.
Deployment Safety Management
- Deployment compliant. Commissioner satisfied.
What clients say
Alex Rivera
The team didn’t just build an automation; they re-engineered our entire operations workflow. We’re moving twice as fast now.
Sarah Jenkins
“Finally, an automation partner who actually understands enterprise security requirements. No hand-waving, just solid execution.”
Michael Rodriguez
“The team understood our complex integration requirements and built something that just works. Worth every penny.”
Marcia Solis
They made sense of our complex requirements and produced a solution that just works. Couldn’t be happier with the value.
Adam Smith
They quickly grasped our complicated integration needs and delivered a solution that works flawlessly. Absolutely worth the investment.
FAQ
Common questions
Everything you need to know before we start working together.
How long does a typical advisory engagement take?
It depends on the scope. A DTAC self-assessment support engagement typically runs 4–6 weeks. A full DCB0129 clinical safety documentation package is usually 6–10 weeks. Ongoing CSO support is structured as a monthly retainer with no fixed end date. We scope every engagement at the discovery call so you know exactly what to expect before we start.
Do you work with early-stage digital health startups?
Yes — and it’s where early investment in compliance pays off most. Many founders wait until a procurement opportunity arises before addressing regulatory requirements, which costs time and deals. We help early-stage teams build the right foundations from the start so compliance becomes a commercial asset, not a last-minute hurdle.
Can you support NHS procurement submissions directly?
Yes. We support teams through NHS and ICB procurement processes including tender preparation, compliance evidence mapping, and DTAC submission. We understand what commissioners look for and how to structure evidence to meet those expectations.
What is DCB0129 and do I need it?
DCB0129 is the NHS clinical risk management standard for health IT systems. If your product is used in a clinical setting, interfaces with patient data, or is being procured by an NHS organisation, you almost certainly need it. It requires a documented clinical safety case, a hazard log, and sign-off by a qualified Clinical Safety Officer. We handle all of this.
Do you work with international clients outside the UK?
Yes. We advise international digital health companies seeking to enter the UK market — covering regulatory positioning, DTAC readiness, NHS procurement strategy, and clinical safety requirements. We also support GCC-based health technology investors and health system buyers navigating the UK digital health landscape.
What happens after the initial discovery call?
Within one business day of your call, we send a written summary of your regulatory position and a proposed engagement scope. If you are ready to proceed, we issue a fixed-scope agreement and begin onboarding. There is no obligation after the discovery call; it is purely a diagnostic conversation..
Can you review compliance documentation we've already started?
Yes. We regularly step into engagements mid-stream; reviewing existing hazard logs, safety cases, DTAC evidence packs, and regulatory submissions. We identify gaps, correct errors, and get your documentation to a standard that holds up under scrutiny. You do not need to start from scratch to work with us.
