The Challenge
Where startups get stuck
Most digital health founders understand their product deeply but underestimate the compliance infrastructure required to sell it to the NHS. Clinical safety documentation, DTAC submissions, and MHRA classification are not optional extras — they are the gatekeepers to every NHS procurement conversation. Founders who delay building this infrastructure until a commissioner asks for it lose deals they should have won.
Our Deliverables
What we help startups with
Regulatory Foundation
Getting your compliance infrastructure right before procurement begins.
- SaMD classification and MHRA pathway
- DCB0129 clinical safety case
- Hazard log creation and sign-off
Procurement Readiness
Building the evidence stack commissioners need to see.
- DTAC self-assessment and submission
- NHS procurement evidence pack
- Clinical safety officer sign-off
Ongoing Compliance
Staying compliant as your product grows.
- CSO retainer cover
- Safety case updates for new releases
- Investor due diligence support
See what's possible
Real scenarios we’ve implemented for startups like yours
First Clinical Safety Case
- Signed safety case. Procurement unlocked.
First DTAC Submission
- First submission passed. Contract secured.
SaMD Classification Review
- Classification confirmed. Right pathway from day one.
Typical outcomes
The impact of getting compliance right early
Clear milestones, constant communication, and zero hand-waving. Here’s how we get from idea to impact.
faster
time
to first NHS procurement conversation when compliance is built before the sales cycle begins
reduction in
submission
rework when clinical safety documentation is built to standard from the start
“Most startup founders come to us six months too late — after a commissioner has already asked for documentation they don’t have. The ones who engage us early convert procurement opportunities the others miss.”
Dr Jide Idowu, Founder, SDHA
- Clinical Safety
First-time DCB0129 documentation built for a mental health SaMD startup. Full hazard log, safety case, and CSO sign-off delivered in seven weeks ahead of an NHS tender deadline.
- DTAC End-to-end
DTAC submission for a remote monitoring startup entering NHS procurement. All 14 standards evidenced and submission passed first review.
- MHRA
SaMD classification review for an AI diagnostic tool. Regulatory position confirmed, MHRA pathway mapped, and investor-ready regulatory strategy document produced.
