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 through deployment and onwards.
Built for
Whether you're entering the NHS market for the first time, responding to a framework or tender, or scaling an existing product, we make compliance the easy part of the deal.
From first conversation to procurement-ready. We help you understand what NHS buyers actually ask for, and prepare for it properly.
Bid-ready clinical safety, DTAC and assurance evidence. We support G-Cloud, HSSF, SBS, ICB tenders and direct trust procurements.
The full DTAC v2 pack, clinical safety, data protection, technical, interoperability and usability. Reviewed, evidenced, defensible.
Not every product is a medical device. We help you make the right call on MHRA registration and UKCA marking, no over-classifying, no fear-selling.
Choose your pathway
Pick the path that fits where you are today. We'll handle the rest.
You're building digital health and want to sell into the NHS. We get you market-ready, tender-ready and safe by design.
Readiness review
Where you are vs where NHS buyers expect you to be.
DTAC v2 & clinical safety pack
DCB0129, hazard log, safety case, done properly.
Medical Device registration, Class I minimum for AI/AVT
MHRA / UKCA registration, classification and technical file for software-as-a-medical-device.
Tender & framework support
Bid-ready evidence for G-Cloud, HSSF, ICB tenders.
You're deploying digital tools into clinical settings. We help you do it safely, defensibly and with confidence.
Deployment risk assessment
Understand the hazards before go-live.
DCB0160 safety case
Owned, documented and ready for assurance.
Supplier review
Check supplier evidence so you don't carry their risk.
Embedded CSO support
A partner alongside your team, not a paperwork bot.
Our mission
DigiSafe is led by founders with lived clinical and frontline experience and a track record of building their own digital health innovations. We've walked the path our clients are on, which is why we don't sell jargon, fear, or gatekeeping.
We help innovators get to market safely, support deployers to roll products out with confidence, get your compliance done properly the first time, and stay alongside you with retained and fractional CSO partnership so nothing slips. Where it makes sense, we bring in trusted specialists from our network so you get the whole picture, not a sales pitch.
A good CSO doesn't tick boxes, they embed quality. We sit alongside your team, share the thinking, guide the decisions and leave you stronger than we found you. That's partnership, not a paperwork exercise.
Awards & recognition
We're proud to be a recognised, award-winning team, across clinical safety, digital health innovation and women in business.
HSJ Awards
Highly Commended
Springboard Women in Innovation
Winner, for our own digital health innovation
Women in Excellence Award
Winner
City Awards
Finalist
Entrepreneur of the Year
Finalist, Founder
Rising Stars
Finalist, Founder
What we do
From a single hazard workshop to a full safety case and ongoing CSO partnership, we tailor our work to your team, your product and your stage of maturity, embedding knowledge and processes that last.
Built for DTAC v2 from day one. We guide software suppliers through the full Digital Technology Assessment Criteria, and support NHS-side assessors reviewing submissions.
Clinical Risk Management for health-IT manufacturers. We complete the documentation set, run hazard workshops and provide a Named Clinical Safety Officer where needed.
A guiding framework for healthcare organisations deploying and using Health IT systems. We help you mitigate risk through every stage of rollout.
End-to-end support for software-as-a-medical-device (SaMD) and connected devices, UK MDR registration, classification, and clinical safety integration.
Specialist clinical safety for AI clinical tools and ambient/AVT scribes, covering model risk, hallucination controls, transcription accuracy and clinician oversight.
CPD-accredited training, awareness sessions and one-to-one mentorship, empowering teams to embed safety into daily practice.
Why us
We believe sharing knowledge is what enables quality health, care and service. Our work is compliant by default, and understandable, transparent and actionable by design.
Digital enablement, inclusion and patient safety sit at the core of everything we do. With real-world experience across software engineering, data, programmes and frontline care, we focus on the people who actually use the systems.
Our sister company, CSO Training Academy, delivers the NHS-equivalent route to becoming a certified CSO, CPD-accredited DCB0129, DCB0160 and DTAC v2 training built and taught by working NHS practitioners. Same rigour, faster access, real lived experience in every module.
The NHS-equivalent standard
Rated by graduates now working across NHS trusts, ICBs and health-tech suppliers.
240+
CSOs certified
4.9/5
Graduate rating
12
2026 cohorts
CPD
Accredited
Kind words
Worked with us? Share your experience, your review appears here.
“Working with Rebecca has enabled us to ensure clinical safety is at the heart of our design and product deployment.”
Shona Blackhall
Director, Product Management, Allocate Software
“Really knowledgeable and brings a great enthusiastic energy to digital safety.”
Jason Broch
Chief Strategic Clinical Information & Innovation Officer, NHS West Yorkshire ICB
“Rebecca's knowledge of digital health systems is extensive and she takes the greatest care in ensuring systems are safe for patients and users alike.”
Victoria Faint
Experienced CSO, Leeds Teaching Hospitals Trust
“Thorough understanding of NHS standards such as DCB0129/0160, high quality clinical safety documentation throughout.”
Natalie Webber
Research & Product Development, Felgains
“Efficient, knowledgeable, and balances the goals of the shared care record with the highest level of patient safety.”
Ian Clucas
Deputy CIO, Interweave
“Rebecca helped me when I first started as a clinical safety officer and her support was a great foundation.”
Lee Rickles
Chief Information Officer, Humber Teaching NHS Foundation Trust
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.
Founder & Senior Clinical Governance Specialist
Occupational Therapist & CSO
GP & CSO
Nurse & Senior CSO
Business Development Manager & Senior CSO
Pharmacist & CSO
GP & Senior CSO
Medical Device Expert, DPO
Marketing Lead & Innovator Social Media Expert
Executive Assistant
Every engagement starts with a 15-min scoping call, a conflict-of-interest check, and a plain-English summary before you commit.
Partners & clients
Trusted delivery, technology and consultancy partners, and clinical safety work delivered for NHS trusts, ICBs, councils, health boards and health-tech innovators across the UK.
Delivery & technology partners
Clients, NHS, councils, health boards & health-tech innovators
Get in touch
Call us directly or send a message via the form, a real person will reply, usually within one working hour.
