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 160 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...

We approached Safehand to provide the Clinical Safety guidance required to achieve DCB0129 compliance. We found Richard to be very approachable and professional, guiding us through the process in a clear and structured way. His expertise was instrumental in helping us navigate the complexities of the DCB0129 framework with confidence. Safehand acted as a trusted partner, and we are very grateful for their assistance in enabling us to achieve this critical milestone.

Julie Somerville
Client Partner Safety, Hexagon

At Log my Care, ensuring compliance with NHS clinical safety standards was paramount and partnering with Safehand provided us with the expert guidance needed to navigate the complexities of DCB 0129. Their team's deep understanding and practical approach made the process seamless, allowing us to integrate safety into every facet of our platform. Thanks to Safehand, we achieved compliance swiftly and efficiently.

Adam Hurst
Co-Founder, CTO, Log My Care

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

Working with Safehand has been a pleasure from first contact with their Managing Director regarding developing a suite of documentation to ensure compliance with DCB0129 to our ongoing relationship with our Clinical Safety Officer contracted via Safehand. They not only have an excellent understanding of the legislative requirements, but have broad experience and knowledge of the healthcare sector which has helped us painlessly navigate our way through what is a complex process and requirement.

Joanne Ross
Business Manager, EPAQ Systems Ltd.

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

Safehand has been a trusted advisor and partner in our DCB0129 compliance process, as well as in providing broader guidance on software as a medical device for Bliksund EWA, our digital record solution for emergency professionals. Their team has demonstrated deep expertise, offering clear and pragmatic advice that integrates seamlessly into our operational approach. Their reliability and ability to simplify complex regulatory requirements have made the entire process smooth and efficient. Safehand's knowledge, professionalism, and practical mindset make them a pleasure to work with, and we highly recommend them to any organisation navigating the landscape of medical regulations and software.

Martin A. Kasseth
Chief Product Officer (CPO), Bliksund

When we first started looking at DCB0129 compliance I didn’t know whether to think “this looks really simple, what’s the problem” or ” this is so complicated I don’t know how we can manage it”. On our first contact with Safehand, it turns out I was right on both counts. It is really complex! And then we met Lucy, our CSO. Right from the start, she worked with us to break the complicated process of a Clinical Safety Review of our BEST system down into simple bite-sized chunks. Her expert eye was able to separate the important from the trivial and then put in place a process that allowed us to address the requirements of the Standard in a logical way that made it easy to understand what was needed. We now have a Hazard Log that identifies the Clinical Risks, demonstrates the controls we have in place to mitigate these, and an excellently-written Clinical Safety Case report. Not only has Lucy enabled us to meet DCB0129, but also given us insight into how we can work in the future to further improve our products.

Mike Birdsall
Senior Software Developer, Soft Options Limited

There is so much to unpack around clinical safety and DCB0129/DCB0160 compliance. Before working with Safehand this was a painfully complex space which organisationally we knew little about. We found it challenging to understand the processes and ways to implement across our organisation. Fast forward and with their help we are making inroads and for all the right reasons.

Safehand have made the experience genuinely positive, interesting and engaging - those are words that I never thought I would use to describe our approach to 'clinical safety'. Marvellously talented people and very kind at heart. A pleasure to work with. There is a reason they have such a good reputation. If you are stuck with clinical safety, give them a call today.

Andy Martin
National ICS Lead, Change Grow Live

When we contacted Safehand early in 2023, we needed help with the complexities of DCB0129. Safehand has proven to be an excellent partner to work with. Small companies like us find it difficult to find the resources to manage compliance and Safehand have accomplished this for us and ensured that our processes are up to the mark. Many thanks Adrian and Lucy.

Clive Morris
Managing Director, TCR (Nottingham) Ltd

"As a small company, it’s just not realistic for us to employ a fulltime DCB 0129 Clinical Safety Officer. Safehand are able to perfectly fill that gap. We get the enormous benefit of a CSO with wide industry experience to work alongside us as we grow. So many clinicians think they can just turn their hand to the complexities of DCB 0129 risk management having completed the mandatory training. The Safehand staff have been doing this work for over a decade and that experience shines through in everything they do. We’ve been working with Adrian for several years as our CSO – he is very friendly, extremely diligent and a true professional."

Taz Aldawoud
CEO, Doc Abode
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More Testimonials

Our clients include...

STCS Ltd
Omron Healthcare UK
CCube Solutions
Cleric Computer Services
Avegen
Northstar Scientific
Ontex
Butterfly Network
Totalmobile
Treatment Technologies Insights (TTI)
Totalmobile
Quantum Health Solutions
Current Health
4S Dawn
Gamma Telecom Ltd
Voice Connect
University Hospital Southampton
EIDO Healthcare logo
EIDO Healthcare
Alcidion
Cyber Media Solutions
ITE Medical
Alcidion
Alcidion
Soft Options
Topcon Healthcare Solutions
Consultant Connect
Alcidion
4S Dawn
Totalmobile
Pontem Data
Medical Graphics UK Limited
Daysix
Illy Systems
Fusion eCare Solutions
Alertive
AliveCor
Cleric Computer Services
Optellum Limited
University Hospital Southampton
Materialise
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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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