About DigiSafe

The credible, trusted team to get clinical safety right.

DigiSafe Compliance is the UK's bespoke clinical safety partner. We work alongside software suppliers and NHS organisations from design to deployment and onwards, making compliance credible, trusted and built around you.

Who we are

A specialist team, not a generalist consultancy.

DigiSafe was founded with one mission: to provide credible, trusted expertise that genuinely helps 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. Every engagement is bespoke, built around your product and your people.

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. We work with you from design to deployment and onwards.

Our founder

Rebecca Wilson

Founder & Senior Clinical Governance Specialist, DigiSafe Compliance and CSO Training Academy

Rebecca founded both DigiSafe Compliance and its sister company, CSO Training Academy. She is GPhC registered, holds a Master's in Health Informatics and brings 10+ years as a senior Clinical Safety Officer, from national programmes at NHS England through to frontline deployments, including four years as Yorkshire and Humber Shared Care Record Clinical Safety Lead.

She has supported the Welsh Government and Welsh health boards, ICBs, trusts and hundreds of innovators, including through the Propel at Yorkshire & Humber bootcamp. Rebecca is also a women's empowerment coach and an innovator in her own right, with products in clinical safety and a grief support app.

Recognition

GPhC registered professional
Highly Commended at the HSJ Awards
Rising Star finalist, Leeds Digital Festival
Entrepreneur of the Year finalist, Leeds Digital Festival
Women in Excellence 2023 finalist, Women in Tech UK

Specialisms

AI and ambient voice technology (AVT) assurance
DCB0129, DCB0160 and DTAC v2
Shared care records, local, regional and national
Medical device compliance, UKCA and MHRA

Systems assured

SystmOne, EMIS and Cleo
Nervecentre, Oracle and Meditech
PACS and RIS imaging systems
Remote patient monitoring, care plans and ReSPECT forms
AVT and AI scribe platforms assured to DCB0129

Global reach

Local, regional and national NHS programmes
England and Wales
USA, including Texas
Canada and India

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.

Bespoke by design

No off-the-shelf templates. We build every safety case and compliance plan around your product, your users and your timeline.

Partnership, not transaction

We work alongside you from design to deployment and onwards, embedded in your team until the job is done properly.

Credible expertise

GPhC registered, award-winning, with 100+ years combined clinical, digital health and regulatory experience.

Trusted outcomes

Safety cases that hold up to scrutiny, evidence that assessors accept, and relationships that last beyond the first submission.

Direct clinical access

Meet the team, Clinical Safety Officers, DPOs & Medical Device Experts.

Multi-disciplinary lived experience across nursing, GP, paramedic, pharmacy, medical devices and data protection. Book a discovery call and we'll match you with the right expert.