What's included
weeks typical time from intake to regulatory strategy document
tHE PROBLEM
The problem with misreading your regulatory status
Since Brexit, the UK operates its own medical device regulatory framework under the MHRA — separate from the EU MDR. For digital health founders, the critical question is whether your product qualifies as a Software as a Medical Device. Getting that classification wrong in either direction is costly.
Overclaiming SaMD status triggers regulatory requirements your product and team are not ready for. Underclaiming it; assuming you are outside scope when you are not, exposes you to enforcement action, procurement rejection, and investor due diligence failures. Neither outcome is recoverable cheaply.
Most teams make this call based on incomplete information, founder intuition, or generic online guidance that does not account for the nuances of their specific product and intended use.
Deliverables
What's included
Strategy
Product review and SaMD classification before any regulatory pathway is committed to.
- Intended use and clinical function review
- SaMD classification analysis
- Regulatory risk and timeline assessment
Build
Full regulatory strategy document and MHRA pathway plan.
- Written regulatory position statement
- MHRA pathway recommendation
- Evidence generation strategy
Handoff
Submission preparation and pre-filing documentation package.
- Technical file structure guidance
- Pre-submission meeting preparation
- Submission-ready regulatory documentation
Support
Ongoing regulatory advisory as your product evolves and submissions progress.
- Post-submission query management
- Product update regulatory review
- Investor due diligence regulatory support
How we work
A process built for results
Clear milestones, expert-led accountability, and no regulatory surprises. Here’s how we get from intake to a confirmed pathway.
Discovery & Classification
We review your product’s intended use, clinical function, and user population to determine definitive SaMD classification under MHRA rules.
Pathway Mapping
We map your full regulatory pathway — registration requirements, technical file obligations, conformity assessment route, and UKCA marking strategy.
Evidence & Documentation Strategy
We design your evidence generation plan and build the pre-submission documentation your pathway requires.
Submit + Ongoing Advisory
We support MHRA interactions, respond to queries, and provide ongoing regulatory advisory as your product develops
MHRA advisory examples
See what's possible
SaMD Classification Review
- Classification confirmed. Right pathway from day one.
Regulatory Strategy Document
- Clear pathway. Investor-ready regulatory position.
Regulatory Due Diligence Support
- Due diligence passed. Deal confidence maintained.
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.
