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.

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If so, we can help...

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

Although experienced in many sectors and methodologies, and well versed in IT risk management; clinical safety, and navigation around DCB0129 compliance in particular, was a new venture for us. What was obvious was that this is no area for naïve stumbling around, or ignorant lip-service to the process. What is required is experienced professionals with established, industry-proven, yet flexible and adaptable processes. This is our experience of working with Safehand, and in particular Lucy, our Clinical Safety Officer. She has quickly become a valued and valuable member of the team, who continues to guide us through what without her could easily be overwhelming, time-consuming and therefore costly processes to meet the standards. Knowledgeable and efficient, Lucy has also been friendly and open to our thoughts and suggestions where appropriate. I would not hesitate in recommending Safehand to other companies in similar circumstances.

Fraser Macindoe
Director, STCS

When we first contacted Safehand in 2020, we knew that we needed a partner for our DCB0129 and Medical Device efforts in order to be successful. Safehand has proven to be a 10/10 partner to work with. They have been able to leverage much of the compliance workload that is difficult for a small company such as us to manage. This has enabled us to learn and progress a lot faster than otherwise would have been possible. Thanks Adrian and Eric.

Rony Lindell
Director of Medical Development, Klinik

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

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

"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

We contacted Safehand to consult on the DCB0129 process with us towards the end of 2024. Being a small team, the process was initially daunting but Paul and the Safehand team helped break the process down for us and provided expert guidance on what was required.

Euan Torano
Software Engineering Manager, BlueSky Wireless

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

Alex Honour played a pivotal role in the successful delivery of our digital clinical safety case for the implementation of a Trust-wide, first-of-type Patient Administration System (PAS). This was an incredibly complex and high-stakes programme, involving not only a significant data migration effort, but also a major shift in working practices for thousands of staff across clinical and operational teams.

Throughout the project, Alex was thorough, approachable, and highly professional—bringing clarity and confidence to a challenging piece of work. What stood out most was Alex’s unwavering commitment to patient safety, which was evident in every question asked, every challenge raised, and every task undertaken.

Alex worked closely with our own Clinical Safety Team and has imparted knowledge and skills for them to carry forward into future projects.

The result was a comprehensive safety case that not only met immediate programme needs but also laid strong foundations for ongoing assurance as the system is further embedded and optimised.

Hayley Grafton
Chief Nursing Information Officer, University Hospitals of Leicester NHS Trust

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)
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More Testimonials

Our clients include...

Trisoft Ltd
Consultant Connect
Technomed
Ontex
Totalmobile
CCube Solutions
Optellum Limited
Strata Health
Immundiagnostik AG
Interactive Studios
Soft Options
Health Diagnostics
Alcidion
Terrafix
Medilogik
Synbiotix Solutions
GPsurgery.net
Ampersand Health
Mobio Interactive PTE
Visiba
Ashtons Hospital Pharmacy
SH:24 Digital
Voice Connect
Schappit
Clinical Computing UK
Ambu
Immundiagnostik AG
4S Dawn
Accenda
BlueSky Wireless
Current Health
mTuitive UK
4S Dawn
Klinik Healthcare Solutions UK
Synbiotix Solutions
EPAQ Systems
Northstar Scientific
BridgeHead Software
Cleric Computer Services
Totalmobile
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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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