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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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

"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

"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

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

“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

“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 has been a pleasure from first contact with their Managing Director regarding developing a suite of documentation to ensure compliance with DCB0129 to our ongoing relationship with our Clinical Safety Officer contracted via Safehand. They not only have an excellent understanding of the legislative requirements, but have broad experience and knowledge of the healthcare sector which has helped us painlessly navigate our way through what is a complex process and requirement.

Joanne Ross
Business Manager, EPAQ Systems Ltd.

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 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

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...

Alcidion
Meditech
epro
Healios
BridgeHead Software
Schappit
4S Dawn
Totalmobile
Synbiotix Solutions
Totalmobile
Genesis Automation Healthcare
BlueSky Wireless
Mindray
Current Health
Clinical Computing UK
Butterfly Network
Medical Graphics UK Limited
Health Diagnostics
Topcon Healthcare Solutions
Voice Connect
Soft Options
Bliksund
Alertive
Ashtons Hospital Pharmacy
AliveCor
TCR (Nottingham)
Accenda
Luscii
Ambu
Consultant Connect
University Hospital Southampton
Daysix
Visiba
Medilogik
Reset Health Logo
Reset Health Clinics
Avegen
LMC Software Ltd
Alcidion
Schiller
Optellum Limited
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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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