Regulatory consultancy, compliance & training for health IT manufacturers and healthcare organisations

Welcome to Safehand

Every day our team of 16 Clinical Safety Officers assists more than 140 organisations with their compliance strategy.

For more information about the DCB 0129/0160 standards and how they work, visit our five minute guide.

Are you trying to solve any of these challenges?
If so, we can help...

Safehand has guided us through the assessment processes for DCB0129 standard. When we first spoke to Adrian, he promised a personal service, working with us through every step of this complex process. That is exactly what they delivered. Shelley‘s clinical background allowed her to understand our software and our work with hospices across the UK where clinical safety is paramount. Shelley, and everyone we have spoken to at Safehand, have been professional and friendly throughout, making the whole process much more manageable. We are looking forward to a long and ongoing relationship with them.

Polly Esplen
Managing Director, The Care Database

Clinical Safety is a vitally important part of our business, and I'm delighted to say that Eric and everyone at Safehand have been truly excellent to work with. Always on hand to offer advice, guidance and information while consistently working at a pace that matches our needs. Eric has been able to adapt to the changing requirements that we have presented with ease, whilst also staying on top of our evolving capability. I really cannot recommend them highly enough!

Sam Wood
Product Manager, Medical Management Systems (Meddbase)

As a small tech company, DCB0129 compliance was a daunting prospect for ShinyMind but Safehand have been extremely professional, informative, and helpful throughout the process. Their patience, flexibility and responsiveness have been particularly valued as our products have evolved and deadlines changed. Having Safehand as part of our team gives us real confidence as ShinyMind moves forward.

Jon Howard
Director, ShinyMind

“Before we worked with Safehand we knew we weren’t compliant with DCB0129 and DCB0160 but we’d found it challenging to get the time to get all the necessary documentation together and embed it within our organisation. With their help we were able to accelerate our compliance strategy and straight-forwardly build all the necessary documentation to comply.
What I like about the Safehand approach is that they are keen to work with us rather than against us. We were concerned about the level of work that would be generated by the process, and that they’d tell us that we need to do everything differently but instead they moulded their approach to how we do things here, and offered pragmatic advice on how to deal with any non-compliant areas.”

Tracy Gardiner
Group Project Services Manager, Ideagen

“Safehand have professionally steered us through the complex process of being DCB0160 compliant for our Shared Care Record. Safehand's, knowledge and guidance along with their practical approach enabled us to assess the current position, adapt and improve along the journey. Thank you for up skilling the Team in knowledge and we look forward to working with Safehand in the future.”

Lynnette Nott
Senior Programme Consultant, Staffordshire and Stoke-on-Trent ICB

“There is no doubt in my mind that Safehand’s guidance helped us complete the work faster, and be even more thorough in our approach.”

Iain Mackenzie
Physician Executive & Clinical Safety Manager, InterSystems
Case Study

As a leading provider of medical devices and digital health solutions, patient safety and clinical compliance are of utmost importance to Mindray. Partnering with Safehand to navigate the regulatory clinical safety environment has been invaluable in achieving accreditation and ensuring the care of our customers and users. Lucy has guided us expertly and rapidly throughout the process, offering considerable insight. Her experience and dedication to our goals have helped the team at Mindray build our understanding and commitment to clinical risk management. We look forward to our continued collaboration with Lucy and Safehand as we develop and enhance our solutions.

John Mendonca
Digital Health Solutions Manager, Mindray UK

Working with Safehand Consulting, and particularly our Clinical Safety Officer Lucy Birks, has been an outstanding experience. Lucy has been phenomenally helpful—pragmatic, calm, and highly skilled at rationalising and simplifying complex regulatory processes. She integrates into our ways of working, providing expert guidance without adding unnecessary burden. Safehand is a consulting firm that genuinely works with you, not just for you, ensuring clinical safety compliance is both achievable and embedded effectively within our organisation. We are grateful for their expertise and ongoing support.

Dr Laura Falvey
Executive Clinical Director, Reset Health and Roczen

"Starting with a blank sheet of paper is so hard when it comes to compliance with DCB0129/0160. Safehand have a wealth of experience and expertise to support Ashtons Hospital Pharmacy Services undertake the risk assessment of our electronic prescribing and administration system, Ashtons e-Works, efficiently and thoroughly."

Yachna Tak
CEO, Ashtons Hospital Pharmacy Services

I'd like to thank Safehand for supporting PocDoc in creating our clinical risk management deliverables for our DTAC assessment and GP Connect onboarding. The Safehand onboarding process was simple and thorough, which meant we could quickly move from briefing to implementation. Safehand has made the process of becoming DCB 0129 compliant straightforward. I would like to make a special mention of Lucy Birks, our appointed Clinical Safety Officer. Lucy has guided us expertly and rapidly throughout the process and offered considerable insight. Her experience and dedication to our aims, has helped the senior management team at PocDoc to build our understanding and commitment to clinical risk management.

Robin Matthews
Chief Technology Officer, PocDoc
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More Testimonials

Our clients include...

PocDoc logo
Vital Signs Solutions Ltd
Ontex
Mindray
Ambu
ServicePRO
Consultant Connect
The Care Database
ShinyMind
Terrafix
Little Green Button
Better
EPAQ Systems
Cleric Computer Services
Priority Solutions
Meditech
CCube Solutions
4S Dawn
Medilogik
Bliksund
Daysix
Synbiotix Solutions
EIDO Healthcare
Visiba
Health Diagnostics
Sitekit
Wabalogic
Quantum Health Solutions
Schappit
Materialise
ITE Medical
Omron Healthcare UK
Clinical Computing UK
University Hospital Southampton
Strata Health
Optellum Limited
Endosoft
Northstar Scientific
Healios
Klinik Healthcare Solutions UK
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How can we help?

For more information about our digital health compliance services get in touch by calling us or using our online enquiry form.

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Become a member

By becoming a Safehand member you can gain access to lots of specialist resources relating to DCB 0129/0160 compliance. Our FAQ contains the answers to dozens of essential questions and our decision tree makes it easy to work out whether you need to comply. You’ll also be added to the distribution list for our newsletter containing everything you need to know about health IT standards and compliance.

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