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.

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.

“I think that like many others, we were doing most of the right things to comply with DCB0129 already, but Safehand were able to assist us greatly in developing, accelerating and implementing our compliance strategy and by providing guidance to us to create a Product Hazard Log and associated Safety Case. The Digital Health Safety Standards and Medical Device Regulations are very specialist areas, so the access provided by Safehand to an experienced Safety Clinical Officer to work alongside us throughout the lifespan of the product, is of great benefit to our organisation.”

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.

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.

Alex Honour played a pivotal role in the successful delivery of our digital clinical safety case for the implementation of a Trust-wide, first-of-type Patient Administration System (PAS). This was an incredibly complex and high-stakes programme, involving not only a significant data migration effort, but also a major shift in working practices for thousands of staff across clinical and operational teams.

Throughout the project, Alex was thorough, approachable, and highly professional—bringing clarity and confidence to a challenging piece of work. What stood out most was Alex’s unwavering commitment to patient safety, which was evident in every question asked, every challenge raised, and every task undertaken.

Alex worked closely with our own Clinical Safety Team and has imparted knowledge and skills for them to carry forward into future projects.

The result was a comprehensive safety case that not only met immediate programme needs but also laid strong foundations for ongoing assurance as the system is further embedded and optimised.

"Thank you so much for all your help. You've been fantastic and I am absolutely delighted with the process and report."

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.

"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."

"Clinical safety and compliance forms the bedrock of a reliable product that can be trusted by healthcare providers. Safehand have supported MaST to develop a portfolio of documents and processes, to ensure we are compliant with DCB 0160. MaST uses data and analytics to support mental health clinicians to make decisions and so having sound advice and clarity on product regulatory position is of utmost importance. Safehand have been supportive and responsive and have helped us navigate the clinical safety landscape."