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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Mobio Interactive is extremely pleased with the diligence and efficiency provided by Safehand. In particular, Natalie Hall has been the Clinical Safety Officer for our digital therapeutic platform AmDTx for over a year. In that time she has guided our team through the entire DCB 0129 certification process, as well as contributing meaningfully to the platform development and overall regulatory and certification strategy. We look forward to an ongoing partnership ensuring the clinical safety of all our digital interventions for mental health and CNS disorders.

Bechara Saab
CEO & Chief Scientist, Mobio Interactive

"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

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 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

"Deploying a national solution in the UK demands a trusted and experienced safety partner. We have been delighted with the work to date – rolling out a product at speed has been challenging across the board, but the way Safehand structures the knowledge transfer and information gathering was a big help. Our CSO has been really great - mammoth effort on her part to keep things moving, and she continues to do a fabulous job."

Chris Ryan
Video Consulting Programmes Director, Attend Anywhere

I would like to take the time to commend Safehand in general, and particularly Oyinkan for an outstanding job in helping the HomeSight solution get to DCB 0129 compliance satisfactorily. Oyinkan was thorough, and exercised awesome due diligence during the entire process, and the remarkable thing is that through her logical thought process and presenting material, always with “why an evidence, or control, or a process is required”, helped us to refine our thinking to bring in a “Clinical Safety” mindset and angle to whatever we do. While we had to work harder to fill the gaps in our documentation, processes and test scripts, we were doing it with vigour knowing that all these contribute to a stronger solution that can stand proud in the market.

Oyinkan is an absolute asset, and a real pleasure to work with. She put us at ease, while politely being firm on the requirements as should be the case. We are happy to retain her as the CSO and we are very pleased with Safehand in terms of the engagement.

Nav Kannan
SVP, Diversification Solutions, Vantiva

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.

Look no further than Safehand for your DCB0129 needs. From the outset the experience and expertise of the Safehand team was clearly demonstrated. Eric Bulwer our Safehand Clinical Safety Officer consultant is very much part of Clinical Computing UK Ltd adding very valuable insights and perspective.

Tim Brennan
Managing Director, Clinical Computing

We found Safehand to be an excellent organisation to work with when completing our DCB0129. They demonstrated their experience and a breadth and depth of knowledge, which when coupled with their ability to communicate complicated issues clearly, made what could have been a difficult process very manageable. We wouldn’t hesitate in recommending them to any other organisation looking for a competent CSO.

Julie Evason
MD, Health Diagnostics
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Our clients include...

BridgeHead Software
University Hospital Southampton
Consultant Connect
Hexagon
Zoom Video Communication
EIDO Healthcare logo
EIDO Healthcare
Inform Health
LMC Software Ltd
PocDoc logo
Vital Signs Solutions Ltd
BlueSky Wireless
Healios
Alcidion
epro
Cleric Computer Services
Totalmobile
Avegen
Zivver
Rivendale Systems
4S Dawn
Ampersand Health
Priority Solutions
Topcon Healthcare Solutions
Synbiotix Solutions
Accenda
Alcidion
Technomed
ITE Medical
Terrafix
Schappit
Ontex
Wabalogic
Synbiotix Solutions
Cyber Media Solutions
Medical Graphics UK Limited
GPsurgery.net
Klinik Healthcare Solutions UK
Omron Healthcare UK
Alcidion
Current Health
Ontex
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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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