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...

“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.

Working with Safehand has been both rewarding and informative, their continued support in ensuring Medilogik EMS continues to comply with its DCB0129 requirements. Their level of detail in understanding our platform and the fast-paced requirement of improving clinical reporting is invaluable to keeping our product current, this is testament to them supplying a CSO who understands the service requirements.

Martin Fletcher
Customer Services Director, Medilogik Limited

As a small tech company, DCB0129 compliance was a daunting prospect for ShinyMind but Safehand have been extremely professional, informative, and helpful throughout the process. Their patience, flexibility and responsiveness have been particularly valued as our products have evolved and deadlines changed. Having Safehand as part of our team gives us real confidence as ShinyMind moves forward.

Jon Howard
Director, ShinyMind

"In a digital health business, we need to work with people who are domain experts who can simplify complex challenges and are great at listening to new ideas and alternative viewpoints. Whether its Medical Device compliance or DCB0129, Safehand just get the job done and deliver what they say they will."

Roko Malkoč, Better by Marand
Product Manager, Better Meds

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

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

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

“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

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

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
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More Testimonials

Our clients include...

ITE Medical
Synbiotix Solutions
Immundiagnostik AG
Visiba
Inform Health
Omron Healthcare UK
Totalmobile
Luscii
Terrafix
Consultant Connect
STCS Ltd
Schappit
Wabalogic
Totalmobile
Optellum Limited
Endosoft
Schiller
Medilogik
EIDO Healthcare logo
EIDO Healthcare
Ontex
Illy Systems
Voice Connect
Ontex
Road to Health Group
Healios
AliveCor
Alcidion
Cleric Computer Services
Medical Graphics UK Limited
Ambu
Ashtons Hospital Pharmacy
Little Green Button
Quantum Health Solutions
Alertive
Ortus Solutions
AliveCor
PocDoc logo
Vital Signs Solutions Ltd
Daysix
Meditech
Immundiagnostik AG
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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.

Featured Articles
The Safehand three-stage approach to evidencing health software testing
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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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