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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"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

"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

"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 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.

As a leading provider of medical devices and digital health solutions, patient safety and clinical compliance are of utmost importance to Mindray. Partnering with Safehand to navigate the regulatory clinical safety environment has been invaluable in achieving accreditation and ensuring the care of our customers and users. Lucy has guided us expertly and rapidly throughout the process, offering considerable insight. Her experience and dedication to our goals have helped the team at Mindray build our understanding and commitment to clinical risk management. We look forward to our continued collaboration with Lucy and Safehand as we develop and enhance our solutions.

John Mendonca
Digital Health Solutions Manager, Mindray UK

"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

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

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

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

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
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Our clients include...

EIDO Healthcare logo
EIDO Healthcare
Totalmobile
Quantum Health Solutions
Terrafix
University Hospital Southampton
Totalmobile
Synbiotix Solutions
Omron Healthcare UK
Alcidion
TCR (Nottingham)
Trisoft Ltd
Visiba
Health Diagnostics
BlueSky Wireless
Alcidion
The Care Database
Wabalogic
Rivendale Systems
Patient Pass
Schappit
Butterfly Network
Zoom Video Communication
Ontex
Current Health
Mas Group
Reset Health Logo
Reset Health Clinics
BridgeHead Software
Ontex
EPAQ Systems
Avegen
ITE Medical
Ontex
GPsurgery.net
Better
AliveCor
Alcidion
Holmusk Europe Limited
Clinical Computing UK
Visiba
Schappit
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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
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?
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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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