Rebecca Wilson
Founder, CEO & Director of Clinical Safety
About DigiSafe
The credible, trusted team to get clinical safety right.
A chosen partner for innovators. We bring knowledge, experience, lived clinical and frontline experience, networks and connections, not just compliance and regulation. More than a tick box, from design to deployment and onwards.
Who we are
A specialist team, not a generalist consultancy.
DigiSafe was founded with one mission: to be the credible, trusted partner innovators choose when they need more than a tick-box compliance service. We bring knowledge, experience, networks and connections that genuinely help organisations meet their compliance, deployment and governance challenges.
Women founded and clinically led, DigiSafe brings together specialists across digital health, clinical safety, software engineering, programme delivery and frontline care. 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.
Meet the team
Leadership, clinical expertise and lived experience.
Our core team works closely with a fantastic pool of talent and trusted associate Clinical Safety Officers, including digital nurses, midwives, clinical informatics leads, advisors and doers. Organisations of any shape and size come to us for the people they need, and we support them from design to deployment and onwards.
Leadership
Stacey Dudley
Chief Operating Officer
Medical device and compliance specialists
Suzanne Ash
Medical Device and Compliance Expert
Tom Falcon
Medical Device and Compliance Expert
Clinical safety team
Steve Robson
Clinical Safety Officer, Nurse
Dr Lizzie Marston
Clinical Safety Officer, GP
Mona Kapinga
Clinical Safety Officer, Pharmacist
Dr Aleem Qureshi
Clinical Safety Officer, GP
Training arm: CSO Training Academy
Our training is delivered through our sister company, CSO Training Academy, with 320+ CSOs trained.
Matthew Olsson
Clinical Safety Officer, Lead Trainer, Paramedic
Zara Mahmood
Clinical Safety Officer, Occupational Therapist
Operations, marketing and client support
Clarity
Marketing Partner & Digital Strategist
Visit website
Shell Mcvey
Business Support Manager
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 people and your timeline.
Partnership, not transaction
We work alongside you from design to deployment and onwards, sharing knowledge, experience and connections, not just ticking boxes.
Credible expertise
Women founded, GPhC registered and award-winning, with deep clinical, digital health and regulatory expertise you can trust.
More than compliance
We bring lived experience, networks and honest advice so you get to market safely and stay there, stronger than you started.
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 choose a partner, not just a provider?
Tell us what you're building or deploying. We'll bring the knowledge, experience and connections to get you there safely.
The team
The people behind the partnership.
Life at DigiSafe
Training, awards & the work behind the standards.
Cohorts trained, workshops delivered, awards recognised, a glimpse of the people and moments that shape our partnership approach.
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