Rebecca Wilson
Founder, CEO & Director of Clinical Safety
Bespoke, credible and trusted, the innovator's chosen partnerClinical safety.
Clinical safety.
Compliance. Regulation. Covered.
Innovators, NHS and care teams, suppliers and start-ups — whoever you are, whatever stage you're at, we know the way. Experts across clinical safety, medical device regulation, AI and digital health strategy, from first idea to deployment and onwards.
- DCB0129/0160
- Clinical safety, done properly
- Class I to III
- Medical device registration
- ISO & AI Act
- 13485, 27001, 9001, 42001
- 320+ CSOs
- Trained via CSO Training Academy
Built for
The innovator's chosen partner. And the NHS's.
Innovators come to us confused, not knowing what they want, what they need, or where their product fits. We do. Health and care deployers often have no subject matter experts and no time to spare. We're here to support both.
Clinical safety, DCB0129 & DCB0160
Named CSOs, hazard logs and safety cases for manufacturers and deployers, including PCNs, ICBs and trusts.
Medical device registration
Classification and MHRA/UKCA registration for software as a medical device, Class I, IIa, IIb and III.
ISO standards & QMS
ISO 13485 quality management, ISO 9001 and ISO 27001 information security, built to fit how your team works.
AI regulation
ISO 42001 AI management systems and EU AI Act readiness, alongside clinical safety for AI and ambient scribes.
Partners & clients
The company we keep.
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
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.
Stacey Dudley
Chief Operating Officer
Suzanne Ash
Medical Device and Compliance Expert
Tom Falcon
Medical Device and Compliance Expert
Steve Robson
Clinical Safety Officer, Nurse
Dr Lizzie Marston
Clinical Safety Officer, GP
Mona Kapinga
Clinical Safety Officer, Pharmacist
Matthew Olsson
Clinical Safety Officer, Lead Trainer, Paramedic
Zara Mahmood
Clinical Safety Officer, Occupational Therapist
Shell Mcvey
Business Support Manager
Every engagement starts with a free 20-min scoping call, a conflict-of-interest check, and a plain-English summary before you commit.
Choose your pathway
Confused about where your product fits? We'll show you.
Pick the path that fits where you are today. Tell us what you're building, or what you need to deploy, and we'll handle the rest.
For Innovators
Software suppliers & start-ups
Most of us start confused, not knowing what we need or where our product fits in the NHS. We tell you exactly that, then get you market-ready, tender-ready and safe by design.
- 1
Readiness review
Where you are vs where NHS buyers expect you to be.
- 2
DTAC v2 & clinical safety pack
DCB0129, hazard log, safety case, done properly.
- 3
Medical Device registration, Class I minimum for AI/AVT
MHRA / UKCA registration, classification and technical file for software-as-a-medical-device.
- 4
Tender & framework support
Bid-ready evidence for G-Cloud, HSSF, ICB tenders.
For Deployers
PCNs, ICBs, NHS trusts & health boards
Many health and care teams have no subject matter experts and no spare time. We plug in as your clinical safety and compliance experts, so you can deploy safely, defensibly and with confidence.
- 1
Deployment risk assessment
Understand the hazards before go-live.
- 2
DCB0160 safety case
Owned, documented and ready for assurance.
- 3
Supplier review
Check supplier evidence so you don't carry their risk.
- 4
Embedded CSO support
A partner alongside your team, not a paperwork bot.
Looking for a team?
We have a fantastic pool of talent, ready to plug in.
Some organisations don't need one specialist, they need a team. Digital nurses, midwives, clinical informatics leads, advisors and doers, drawn from our own people and our associate pool. We support organisations of any shape and size.
- Digital nurses
- Midwives
- Clinical informatics
- Advisors
- Doers
- Named CSOs
Our mission
The chosen partner for innovators. Here to support the NHS.
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.
What we do
Services that meet you where you are.
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.
DCB0129, Manufacturers
Clinical risk management for health IT manufacturers. We complete the documentation set, run hazard workshops and provide a named Clinical Safety Officer.
- Clinical Risk Management System (CRMS)
- Clinical Risk Management Plan (CRMP)
- Hazard Log
- Clinical Safety Case Report
DCB0160, Deployers
For PCNs, primary care, ICBs, trusts and health boards deploying health IT. We help you go live safely and defensibly.
- Deployment risk assessment
- Supplier evidence review
- Safety case ownership
- Ongoing assurance
CSO Services & Specialists
Fractional, retained or project CSOs and specialists from our clinical team and associate pool, including digital nurses, midwives, GPs, pharmacists, paramedics, OTs and clinical informatics leads.
- Named and fractional CSO
- Clinical informatics and advisory support
- Cover for a departing CSO
- A whole team if you need one
Medical Device Registration
Software as a medical device support, from qualification and classification to MHRA registration and UKCA marking.
- Class I, IIa, IIb and III classification
- MHRA / UKCA registration
- Technical file
- Post-market surveillance
ISO Standards & QMS
Quality and security management systems that NHS buyers and regulators expect, scaled to your team.
- ISO 13485 medical device QMS
- ISO 9001 quality management
- ISO 27001 information security
- Gap analysis & audit readiness
AI Regulation & Assurance
AI governance and clinical safety for AI tools and ambient voice scribes, aligned to international AI rules.
- ISO 42001 AI management system
- EU AI Act readiness
- AI & AVT hazard controls
- Clinician-in-the-loop assurance
DTAC v2 & Market Readiness
The full DTAC v2 pack plus NHS market readiness, so buyers can say yes with confidence.
- DTAC v2 pre-submission review
- Full DTAC documentation pack
- Evidence buyers and assessors trust
- NHS market readiness
Strategy, Roadmaps & Leadership
Need a strategist or a Chief Operating Officer? We shape your roadmap, your team and the future of your product, backed by experience, connections and straight advice.
- Digital health strategy roadmap
- Fractional Chief Operating Officer
- Team shaping and operating model
- Advice, networks and connections
CSO Training
Clinical Safety Officer training through our sister company, CSO Training Academy. CPD-accredited, covering DCB0129, DCB0160, DTAC and AI.
- Clinical Safety Officer course
- Practitioner training
- Team awareness sessions
- 1:1 mentorship
Not sure what you need? Contact us today.
Most people arrive confused about what's required and where their product fits. Tell us where you are and we'll shape the right support around you, no jargon, no obligation.
Packages
One partner, end to end.
Two ways to work with us, shaped around where you are. Every package is tailored to your product and your team, so tell us what you need and we'll build it around you.
The Complete Package
Everything, taken care of. We start with a full gap analysis, deliver your compliance and regulation work, then carry you through to market viability with our marketing partner. Design to deployment and onwards, with one trusted team.
- Full gap analysis across safety, quality and security
- Compliance and regulation done for you
- Clinical safety, DTAC, ISO and device registration
- Market viability and positioning with our marketing partner
- Ongoing partnership beyond go-live
Clinical Safety & DTAC Package
Your NHS readiness covered in one place. Full clinical safety support, the complete DTAC v2 pack including information governance and technical security, plus medical device Class I registration.
- DCB0129 and DCB0160 clinical safety, with a named CSO
- Full DTAC v2 pack, clinical safety, IG and technical security
- Medical device Class I registration with MHRA
- Evidence buyers and assessors can trust
- Specialist support from our clinical team
Building with AI? Developing an AI product? Deploying AI in care?
Then you need our help and support. Experts in all AI and medical devices: AI assurance, ISO 42001, EU AI Act readiness and clinical safety for AI, from people who do this every day.
Why us
Sharing knowledge so good care can scale.
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.
- Embedding processes with people, not bolting them on
- Clear, transparent documentation with recommendations
- Covering all health & care sectors, UK and international standards
- Backed by Digital Health Specialists, clinical, technical and operational
● Sister company · NHS-equivalent training
Become a certified Clinical Safety Officer.
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.
- NHS-equivalent curriculum
- CPD-accredited certificates
- Live cohorts + on-demand
- Taught by practising CSOs
The NHS-equivalent standard
Rated by graduates now working across NHS trusts, ICBs and health-tech suppliers.
320+
CSOs certified
12
2026 cohorts
CPD
Accredited
DCB0129/0160
Course content
Kind words
What clients say.
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
Your questions answered
DCB0129, DCB0160, MHRA registration & ISO standards
Which clinical safety standard applies? Is your software a medical device? Which ISO standard fits your team? Read detailed answers for innovators, PCNs, ICBs, trusts and suppliers, with links to official guidance.
Read the clinical safety, MHRA and ISO FAQsOur work in action
Training cohorts, NHS workshops & conference stands
See DigiSafe in action — CSO Training Academy cohorts, hazard workshops, HETT North stands, awards and the team behind the partnership.
Browse the media wallGet in touch
Contact us today.
Not sure what you need yet? That's normal, and a perfectly good place to start. Fill in the contact form and we'll be in touch within 24 hours.