"Safehand have been invaluable helping us meet the clinical safety documentation requirements for our expansion in the UK market. From beginning to the end, they explained every aspect of the process and took steps to ensure that we were fully aware of why we were producing each deliverable. Following a well-designed, well delivered plan, it was as much an educational experience as a consulting engagement. We are delighted with our interaction with Safehand and a special thank you to our CSO for a tremendous job."

Working with Safehand on our DCB0129 compliance was straightforward. The process was well established and robust. Our allocated CSO was an expert with real-world experience in our field and was able to quickly understand the product and its applications. We are very happy with the flexibility in supporting ongoing compliance.

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.

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.

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.

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.

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.

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.

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.

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.