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...

EIDO Healthcare have a history of providing high quality patient information to support informed consent in NHS and private hospitals. When we expanded into the digital healthcare space, we thought that Clinical Safety was something we could do ourselves…how wrong we were! Luckily we asked Safehand for help and they appointed Natalie as our Clinical Safety Officer. She expertly guided us through the DCB0129 process with extensive regulatory knowledge, rationality and common sense. We have a retained services agreement with Safehand and enjoy having a CSO on our team.

Rob Hughes
Digital Director, EIDO Systems International Ltd.
Case Study

"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 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 think that like many others, we were doing most of the right things to comply with DCB0129 already, but Safehand were able to assist us greatly in developing, accelerating and implementing our compliance strategy and by providing guidance to us to create a Product Hazard Log and associated Safety Case. The Digital Health Safety Standards and Medical Device Regulations are very specialist areas, so the access provided by Safehand to an experienced Safety Clinical Officer to work alongside us throughout the lifespan of the product, is of great benefit to our organisation.”

Andy Crowther-Green
Sales Director, Terrafix 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

"Safehand Consulting have become a very important part of our company.  Their level of expertise, sensible advice and approachability make them a great company to work with. In addition their help in setting up in-house processes has been invaluable. We would recommend them to anyone looking for Clinical Safety guidance and advice."

Steve Treadwell
Director, Silicon Practice

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

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

Safehand managed to walk us through the DCB 0129 assessment process in a highly professional manner. Hadi and Adrian were extremely capable and took the time to really understand our business processes and application in the broader healthcare market. This is a daunting project to undertake without professional guidance and I will recommend Safehand to those invested in clinical safety and risk mitigation to lead them through this process.

Dr. Conrad Fivaz
President, Priority Solutions Inc.
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More Testimonials

Our clients include...

Omron Healthcare UK
PocDoc logo
Vital Signs Solutions Ltd
Accenda
Rivendale Systems
Interactive Studios
Schappit
AliveCor
The Care Database
Ontex
Patient Pass
Avegen
Luscii
Alcidion
Strata Health
Alcidion
Ambu
Totalmobile
Treatment Technologies Insights (TTI)
Optellum Limited
Illy Systems
Visiba
Butterfly Network
EIDO Healthcare logo
EIDO Healthcare
Schappit
Holmusk Europe Limited
STCS Ltd
Better
Consultant Connect
Alcidion
Bliksund
Current Health
mTuitive UK
Ambu
Gamma Telecom Ltd
BlueSky Wireless
Cleric Computer Services
Totalmobile
Wabalogic
TCR (Nottingham)
Healios
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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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