What's included
STANDARDS covered across the DTAC framework
The problem
The problem with DIY DTAC submissions
DTAC is not a checkbox exercise. It covers 14 standards across clinical safety, data protection, technical security, interoperability, and usability — and commissioners are increasingly sophisticated at identifying submissions that are incomplete or poorly evidenced.
Most teams underestimate the scope until they are already in a procurement process with a deadline. A submission built under pressure, without specialist input, rarely passes first review. And every failed submission delays revenue and damages your credibility with the buying organisation.
Deliverables
What's included
Strategy
Full DTAC scope review and evidence gap analysis before any writing begins.
- Current compliance position audit
- Gap analysis across all 14 standards
- Evidence collection plan and timeline
Build
Structured construction of your DTAC submission with supporting evidence.
- DTAC self-assessment completion
- Evidence pack compilation and formatting
- Clinical safety and data protection alignment
Handoff
Pre-submission review, sign-off, and submission support.
- Independent submission quality review
- Gap resolution before filing
- Submission-ready final documentation pack
Support
Post-submission advisory and resubmission support if required.
- Commissioner query responses
- Resubmission support if initial review fails
- Annual review and re-certification support
How we work
A process built for results
Clear milestones, consultant-led accountability, and zero shared guessing. Here’s how we get from intake to submission.
Discovery & Scoping
We review your product, intended use, data flows, and current compliance position across all 14 DTAC standards
Gap Analysis & Evidence Mapping
We identify every gap, prioritise by risk, and build a structured evidence collection plan
Build & Review
We complete the self-assessment, compile your evidence pack, and conduct an independent pre-submission review
Submit + Support
We support submission, respond to commissioner queries, and manage any resubmission requirements
DTAC advisory examples
See what's possible
Full DTAC Build
- First submission passed. Procurement unlocked.
Failed Submission Rescue
- Gaps closed. Resubmission approved.
DTAC Renewal & Update
- Compliance maintained. No procurement gaps.
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.
