What's included
faster time to clinical safety sign-off
THE PROBLEM
The problem with leaving clinical safety to chance
Most digital health teams know they need a Clinical Safety Officer; but hiring one full-time is expensive, and finding someone with the right NHS-facing experience is harder still. The result is teams either delay compliance until a procurement deadline forces the issue, or they appoint an internal lead who lacks the specialist knowledge to do it properly.
Underdocumented safety cases get rejected. Hazard logs that don’t meet standard fail clinical review. And a single gap in your DCB0129 submission can cost you a procurement opportunity worth months of work.
Deliverables
What's included
Strategy
Scoping and risk framework design before any documentation begins.
- Product scope and intended use review
- Clinical context and hazard identification
- Risk classification framework
Build
Full construction of your clinical safety documentation to NHS standard.
- Clinical safety case document
- Hazard log creation and management
- DCB0129 / DCB0160 evidence pack
Handoff
Formal sign-off, submission preparation, and internal team enablement.
- CSO sign-off and certification
- Submission-ready documentation pack
- Internal team handover briefing
Support
Ongoing CSO cover for audits, updates, and procurement queries.
- Safety case update management
- Audit cycle and review support
- Procurement and due diligence responses
How we work
A process built for results
Clear milestones, constant communication, and zero hand-waving. Here’s how we get from idea to impact.
Discovery & Scoping
We map your product scope, clinical context, intended use, and current compliance position.
Build Documentation
We build your hazard log, safety case, and all required DCB0129/DCB0160 evidence to NHS standard.
Review + Sign-off
Independent clinical review, gap resolution, and formal CSO sign-off before submission.
Launch + Monitor + Renew
Ongoing CSO cover for updates, audits, procurement queries, and regulatory changes.
CSO outsourcing examples
See what's possible
First-time Safety Case
- Procurement-ready. First submission passed.
Safety Case Rescue
- Gaps closed. Review passed second time.
Retainer CSO Cover
- Always covered. No compliance gaps.
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.
