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.

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.

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.

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.

“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.”

We approached Safehand to provide the Clinical Safety guidance required to achieve DCB0129 compliance. We found Richard to be very approachable and professional, guiding us through the process in a clear and structured way. His expertise was instrumental in helping us navigate the complexities of the DCB0129 framework with confidence. Safehand acted as a trusted partner, and we are very grateful for their assistance in enabling us to achieve this critical milestone.

"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."

"We found our Safehand consultant to be extremely competent and knowledgeable and able to very quickly assimilate what our product was about.  We were pleasantly surprised how Safehand chose to make use of our own tools and ways of doing things. In building our Hazard Log and Safety Case, they didn’t try to re-invent the wheel or burden us with unnecessary paperwork."

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.

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.