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.

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Our Safehand Clinical Safety Officer, Hadi, provided professional and enthusiastic support to add DCB0129 compliance to Optellum’s lung cancer AI medical device. We were very pleased with the quality of the documents Hadi produced, and the speed and efficiency with which they were delivered. We look forward to Safehand’s ongoing support for getting our product to the UK market.

David Arrowsmith
RA/QA Manager, Optellum

We contacted Safehand as we needed an experienced partner and specialist to guide us through our DCB0129 assessment for our patient and general practitioner apps with confidence. Safehand worked hand in hand with us to understand and assess our product and processes, providing all the necessary templates along the way. Having gone through the assessment, we’re now in a much better position and able to incorporate clinical safety into our requirements gathering process, and identify any areas for improvement, with Safehand supporting us along the way. Thank you for all your support and expertise Michelle and Adrian.

Maria Walschikow
Head of Operations, Substrakt Health

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

"Thank you so much for all your help. You've been fantastic and I am absolutely delighted with the process and report."

Fiona Steven
CEO, Know As You Go

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

Massive thank you to all the wonderful folks at Safehand for their help getting Tellmi DCB1029 compliant. Their expertise and advice was invaluable during the whole process. Clinical safety is a difficult and complex process but thanks to the cool heads at Safehand it isn't remotely daunting. We'd recommend them to anyone without hesitation!

Ben Allen
Project Owner, Tellmi

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

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

As a leading supplier of critical Emergency and non-emergency Ambulance systems, our focus is always to deliver clinically safe and compliant systems and functionality to our customers. In partnership with the expert and knowledgeable team at Safehand, we have been able to ensure compliance with DCB0129 across all our platforms. The team at Safehand have a unique understanding of the challenges that supplier organisations face in the ever-challenging digital world. Their approach is one of collaborative working, creating all the required documentation, providing clear and constructive feedback and advice, and supporting the overall process as a critical friend. Understanding that Clinical Safety is an on-going process, Safehand are now further supporting us with embedding Clinical Safety into the heart of our culture.

Phil Smith
Customer Engagement and Experience, Cleric Software Solutions
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More Testimonials

Our clients include...

Ambu
Ontex
Topcon Healthcare Solutions
Strata Health
Quantum Health Solutions
University Hospital Southampton
AliveCor
University Hospital Southampton
The Care Database
CCube Solutions
Ambu
Mindray
Holmusk Europe Limited
Omron Healthcare UK
Mobio Interactive PTE
Klinik Healthcare Solutions UK
Patient Pass
Alcidion
4S Dawn
Health Diagnostics
Zivver
ServicePRO
Icentia
Healios
Soft Options
Sitekit
EIDO Healthcare
Mas Group
epro
Schappit
Visiba
Synbiotix Solutions
Alcidion
Cleric Computer Services
Voice Connect
GPsurgery.net
Mindray
BridgeHead Software
Etc, At BT Group
Technomed
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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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