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...

When we first contacted Safehand in 2020, we knew that we needed a partner for our DCB0129 and Medical Device efforts in order to be successful. Safehand has proven to be a 10/10 partner to work with. They have been able to leverage much of the compliance workload that is difficult for a small company such as us to manage. This has enabled us to learn and progress a lot faster than otherwise would have been possible. Thanks Adrian and Eric.

Rony Lindell
Director of Medical Development, Klinik

Safehand managed to walk us through the DCB 0129 assessment process in a highly professional manner. Hadi and Adrian were extremely capable and took the time to really understand our business processes and application in the broader healthcare market. This is a daunting project to undertake without professional guidance and I will recommend Safehand to those invested in clinical safety and risk mitigation to lead them through this process.

Dr. Conrad Fivaz
President, Priority Solutions Inc.

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

"Starting with a blank sheet of paper is so hard when it comes to compliance with DCB0129/0160. Safehand have a wealth of experience and expertise to support Ashtons Hospital Pharmacy Services undertake the risk assessment of our electronic prescribing and administration system, Ashtons e-Works, efficiently and thoroughly."

Yachna Tak
CEO, Ashtons Hospital Pharmacy Services

“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

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

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

"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

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

There is so much to unpack around clinical safety and DCB0129/DCB0160 compliance. Before working with Safehand this was a painfully complex space which organisationally we knew little about. We found it challenging to understand the processes and ways to implement across our organisation. Fast forward and with their help we are making inroads and for all the right reasons.

Safehand have made the experience genuinely positive, interesting and engaging - those are words that I never thought I would use to describe our approach to 'clinical safety'. Marvellously talented people and very kind at heart. A pleasure to work with. There is a reason they have such a good reputation. If you are stuck with clinical safety, give them a call today.

Andy Martin
National ICS Lead, Change Grow Live
1 2 3 5
More Testimonials

Our clients include...

Strata Health
Inform Health
Schappit
ITE Medical
Klinik Healthcare Solutions UK
Gamma Telecom Ltd
CCube Solutions
Zoom Video Communication
Current Health
Icentia
Mobio Interactive PTE
Alcidion
Better
Fusion eCare Solutions
BlueSky Wireless
LMC Software Ltd
Northstar Scientific
Consultant Connect
Alcidion
SH:24 Digital
EPAQ Systems
Genesis Automation Healthcare
Synbiotix Solutions
Visiba
Schiller
Butterfly Network
Quantum Health Solutions
Schappit
EIDO Healthcare logo
EIDO Healthcare
Ontex
Cleric Computer Services
Treatment Technologies Insights (TTI)
Healios
Ortus Solutions
Meditech
STCS Ltd
Cyber Media Solutions
Alcidion
University Hospital Southampton
University Hospital Southampton
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