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 150 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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I'd like to thank Safehand for supporting PocDoc in creating our clinical risk management deliverables for our DTAC assessment and GP Connect onboarding. The Safehand onboarding process was simple and thorough, which meant we could quickly move from briefing to implementation. Safehand has made the process of becoming DCB 0129 compliant straightforward. I would like to make a special mention of Lucy Birks, our appointed Clinical Safety Officer. Lucy has guided us expertly and rapidly throughout the process and offered considerable insight. Her experience and dedication to our aims, has helped the senior management team at PocDoc to build our understanding and commitment to clinical risk management.

Robin Matthews
Chief Technology Officer, PocDoc

Clinical safety has always been central to our Theseus health and wellbeing platform’s development and it’s essential for our company to be compliant with DCB0129. Engaging with Safehand was a straightforward decision based on the company’s track record in clinical safety. We have been very impressed with our Clinical Safety Officer’s experience, knowledge and approachability in helping us develop and maintain our Clinical Safety Management System.

Stephen Beamond
Business Analyst, Cyber Media Solutions Ltd

“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.

"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

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

Our Safehand Clinical Safety Officer, Hadi, provided professional and enthusiastic support to add DCB0129 compliance to Optellum’s lung cancer AI medical device. We were very pleased with the quality of the documents Hadi produced, and the speed and efficiency with which they were delivered. We look forward to Safehand’s ongoing support for getting our product to the UK market.

David Arrowsmith
RA/QA Manager, Optellum

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

Although experienced in many sectors and methodologies, and well versed in IT risk management; clinical safety, and navigation around DCB0129 compliance in particular, was a new venture for us. What was obvious was that this is no area for naïve stumbling around, or ignorant lip-service to the process. What is required is experienced professionals with established, industry-proven, yet flexible and adaptable processes. This is our experience of working with Safehand, and in particular Lucy, our Clinical Safety Officer. She has quickly become a valued and valuable member of the team, who continues to guide us through what without her could easily be overwhelming, time-consuming and therefore costly processes to meet the standards. Knowledgeable and efficient, Lucy has also been friendly and open to our thoughts and suggestions where appropriate. I would not hesitate in recommending Safehand to other companies in similar circumstances.

Fraser Macindoe
Director, STCS

As an emerging digital agency venturing into healthcare software products, we found ourselves trying to navigate the complexities of the world of Clinical Safety and DCB0129 compliance. Safehand has proved to be an invaluable partner in this journey. Their meticulous approach and commitment to understanding our product ensures our compliance is robust and fit for purpose. Our nominated CSO, Lisa, guides us every step of the way, instilling the utmost confidence in us. We highly recommend Safehand for their professionalism, dedication, and expertise.

Tom Montgomery
Head of operations, Trauma App

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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More Testimonials

Our clients include...

Technomed
Holmusk Europe Limited
Patient Pass
Mobio Interactive PTE
Mas Group
TCR (Nottingham)
Priority Solutions
Schappit
Schiller
Zoom Video Communication
Totalmobile
Gamma Telecom Ltd
Ontex
Wabalogic
Strata Health
Inform Health
Better
Interactive Studios
Alcidion
CCube Solutions
Mindray
Northstar Scientific
Bliksund
Visiba
Zivver
mTuitive UK
BlueSky Wireless
Current Health
Totalmobile
Genesis Automation Healthcare
Optellum Limited
4S Dawn
Hexagon
Avegen
Soft Options
Ampersand Health
Alcidion
Klinik Healthcare Solutions UK
Luscii
Reset Health Logo
Reset Health Clinics
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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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