About DigiSafe
The team trusted to get clinical safety right.
DigiSafe Compliance is the UK's go-to partner for clinical safety, DTAC v2, medical device compliance and AI/ambient scribe assurance — for software suppliers building digital health, and for the NHS organisations deploying it.
Who we are
A specialist team — not a generalist consultancy.
DigiSafe was founded with one mission: provide the expertise to genuinely help organisations meet their compliance, deployment and governance challenges — without the jargon and without the gatekeeping.
With over 100 years of combined experience across digital health, clinical safety, software engineering, programme delivery and frontline care, our Digital Health Specialists bring the depth most consultancies simply can't match.
We support software suppliers of every size — from solo founders shipping their first app to enterprise vendors deploying nationally — and the NHS trusts, ICBs and health boards that rely on those products every day.
What we cover
Built for what's next in digital health.
Standards are evolving fast — DTAC v2, AI regulation, software-as-a-medical-device. We're already there, so you don't have to catch up.
DTAC v2
The new Digital Technology Assessment Criteria — covered end-to-end for suppliers and assessors.
DCB0129 & DCB0160
Clinical Risk Management for manufacturers and deployers of Health IT systems.
Medical Devices
MHRA registration, UKCA marking, SaMD classification and technical files.
AI & Ambient Scribe
Specialist safety cases for AI clinical tools, AVT scribes and clinician-in-the-loop workflows.
DSP Toolkit
Practical support to complete and maintain your Data Security & Protection toolkit.
Training & Mentorship
CPD-accredited courses via our sister company, CSO Training Academy.
How we work
Four things you can count on.
Safety, properly
We don't tick boxes. We build safety cases that hold up to scrutiny — and protect the people using your product.
People before paperwork
Compliance only works when teams understand it. We embed the process with the people who'll live it.
Knowledge shared
Mentorship, training and plain-English guidance — so your team gets stronger with every engagement.
Patient-first, always
Patient safety, digital inclusion and clinician wellbeing sit at the centre of every recommendation we make.
Who we work with
If you're building, deploying or assessing digital health — we're for you.
- Software suppliers needing DTAC v2 and clinical safety compliance
- Medical device manufacturers and SaMD vendors
- AI and ambient scribe (AVT) product teams
- NHS trusts, ICBs and health boards deploying health-IT
- Innovators and start-ups preparing for NHS market entry
- Established vendors maintaining ongoing compliance
Ready to make compliance the easy part?
Tell us what you're building or deploying — we'll tell you exactly what compliance looks like for it.