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.

“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.”

“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.”

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.

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.

"Deploying a national solution in the UK demands a trusted and experienced safety partner. We have been delighted with the work to date – rolling out a product at speed has been challenging across the board, but the way Safehand structures the knowledge transfer and information gathering was a big help. Our CSO has been really great - mammoth effort on her part to keep things moving, and she continues to do a fabulous job."

“As a leading provider of patient self-management tools in the UK and globally, Omron have a strong history of quality management and compliance. We reached out to Safehand to support us with our regulatory readiness for our new category of remote patient monitoring solutions. We have been consistently impressed with the level of expertise within the Safehand team, their deep knowledge of the regulatory environment and the ability to develop clear and comprehensive assessments from often complex product requirements and functionality. The quality of output has been recognised by our customers and this has helped us to strengthen our own commercial relationships.”

"As a small company, it’s just not realistic for us to employ a fulltime DCB 0129 Clinical Safety Officer. Safehand are able to perfectly fill that gap. We get the enormous benefit of a CSO with wide industry experience to work alongside us as we grow. So many clinicians think they can just turn their hand to the complexities of DCB 0129 risk management having completed the mandatory training. The Safehand staff have been doing this work for over a decade and that experience shines through in everything they do. We’ve been working with Adrian for several years as our CSO – he is very friendly, extremely diligent and a true professional."

Clinical Safety is a vitally important part of our business, and I'm delighted to say that Eric and everyone at Safehand have been truly excellent to work with. Always on hand to offer advice, guidance and information while consistently working at a pace that matches our needs. Eric has been able to adapt to the changing requirements that we have presented with ease, whilst also staying on top of our evolving capability. I really cannot recommend them highly enough!

I'd like to thank Safehand for supporting PocDoc in creating our clinical risk management deliverables for our DTAC assessment and GP Connect onboarding. The Safehand onboarding process was simple and thorough, which meant we could quickly move from briefing to implementation. Safehand has made the process of becoming DCB 0129 compliant straightforward. I would like to make a special mention of Lucy Birks, our appointed Clinical Safety Officer. Lucy has guided us expertly and rapidly throughout the process and offered considerable insight. Her experience and dedication to our aims, has helped the senior management team at PocDoc to build our understanding and commitment to clinical risk management.