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.

Are you trying to solve any of these challenges?
If so, we can help...

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

“Working with Safehand has been a breath of fresh air in what can be a complex and detailed area. We are a very fast moving health tech company with a release schedule we work hard to maintain. Safehand have consistently demonstrated that they understand our process and are willing to work with us. They challenge us where appropriate but understand us, our culture and our mission. We feel confident that Safehand isn’t just offering us a cookie cutter service but it is truly bespoke. Everyone on the Safehand team is a delight to work with and incredibly knowledgeable. I would not hesitate to recommend them to anyone."

Chris Eldridge
Director of Operations, Mayden

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

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

“We were and continue to be delighted with our interactions with Safehand. From the first email, through to the production of our hazard log, clinical safety workshop and final report we experienced the highest level of professionalism, matched with not only extensive knowledge of the clinical safety issues but real enthusiasm to make our product better. This enthusiasm has led our team to become even more focussed on clinical safety and led to a real organisational change in designing, improving and releasing our code updates. We are looking forward to working with Safehand as we develop and enhance our offering.”

Anne Lamb
Director of Operations, FDS Dental Referrals

Working with Safehand Consulting, and particularly our Clinical Safety Officer Lucy Birks, has been an outstanding experience. Lucy has been phenomenally helpful—pragmatic, calm, and highly skilled at rationalising and simplifying complex regulatory processes. She integrates into our ways of working, providing expert guidance without adding unnecessary burden. Safehand is a consulting firm that genuinely works with you, not just for you, ensuring clinical safety compliance is both achievable and embedded effectively within our organisation. We are grateful for their expertise and ongoing support.

Dr Laura Falvey
Executive Clinical Director, Reset Health and Roczen
Case Study

The experience held by Safehand and their clear expertise in clinical safety and health tech has been fundamental in reaching DCB0129 compliance.  Safehand’s impact has been much wider than just compliance, it has woven clinical safety into all aspects of our product design, development, delivery and support. Safehand’s ability to rapidly understand the product, and how it is utilised in the real world is refreshing. The expertise brought by the team at Safehand has brought benefits not only to our organisation but every customer who uses an Inform Health product.

Andrew Denman
Product Director, Inform Health

Mobio Interactive is extremely pleased with the diligence and efficiency provided by Safehand. In particular, Natalie Hall has been the Clinical Safety Officer for our digital therapeutic platform AmDTx for over a year. In that time she has guided our team through the entire DCB 0129 certification process, as well as contributing meaningfully to the platform development and overall regulatory and certification strategy. We look forward to an ongoing partnership ensuring the clinical safety of all our digital interventions for mental health and CNS disorders.

Bechara Saab
CEO & Chief Scientist, Mobio Interactive

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
1 2 3 5
More Testimonials

Our clients include...

Clinical Computing UK
Totalmobile
Interactive Studios
Schiller
Totalmobile
Visiba
AliveCor
EPAQ Systems
Cyber Media Solutions
Mas Group
Alcidion
Wabalogic
Ontex
ServicePRO
Little Green Button
TCR (Nottingham)
Technomed
Reset Health Logo
Reset Health Clinics
Icentia
Synbiotix Solutions
Bliksund
Ampersand Health
Ambu
Endosoft
Patient Pass
Quantum Health Solutions
Schappit
Zoom Video Communication
Daysix
University Hospital Southampton
Treatment Technologies Insights (TTI)
Medilogik
Terrafix
Alcidion
Butterfly Network
Omron Healthcare UK
Medical Graphics UK Limited
LMC Software Ltd
Avegen
Ontex
1 2 3
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.

Register for Free MembershipExisting Members Login
chevron-leftchevron-right