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

Welcome to Safehand

If you manufacture health software or you're an NHS organisation implementing health software, you need to comply with the mandatory safety regulations - in particular DCB 0129, DCB 0160 and the Medical Device Regulation. Every day our team of ten Clinical Safety Officers assists more than 80 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...

“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

"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

"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

"In completing the work supported by Safehand and its detailed knowledge it has also allowed us to integrate the safety processes in to our existing Quality Management system (ISO 9001/2015) allowing us to better manage the risk of software change going forward.”

John Hopkins
Chief Executive, Med eTrax
Case Study

"Clinical safety and compliance forms the bedrock of a reliable product that can be trusted by healthcare providers. Safehand have supported MaST to develop a portfolio of documents and processes, to ensure we are compliant with DCB 0160. MaST uses data and analytics to support mental health clinicians to make decisions and so having sound advice and clarity on product regulatory position is of utmost importance. Safehand have been supportive and responsive and have helped us navigate the clinical safety landscape."

Caroline Gadd
Director, MaST

“As a leading provider of patient self-management tools in the UK and globally, Omron have a strong history of quality management and compliance. We reached out to Safehand to support us with our regulatory readiness for our new category of remote patient monitoring solutions. We have been consistently impressed with the level of expertise within the Safehand team, their deep knowledge of the regulatory environment and the ability to develop clear and comprehensive assessments from often complex product requirements and functionality. The quality of output has been recognised by our customers and this has helped us to strengthen our own commercial relationships.”

Paul Stevens
Director Connected Services and Solutions, Omron Healthcare Ltd.
More Testimonials

Our clients include...

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.

Featured Articles
The Safehand three-stage approach to evidencing health software testing
Ever wondered how the work of the DCB 0129/0160 Clinical Safety Officer integrates into an organisation’s testing activities? Our three-stage framework sheds light on an otherwise complex area.
Five things you should do today as a DCB 0129/0160 Clinical Safety Officer
Often the key to efficiency and effectiveness is in forming good habits. So, what are the top five things you can do right now to be a proactive and successful Clinical Safety Officer?
More Articles

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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