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.

Although experienced in many sectors and methodologies, and well versed in IT risk management; clinical safety, and navigation around DCB0129 compliance in particular, was a new venture for us. What was obvious was that this is no area for naïve stumbling around, or ignorant lip-service to the process. What is required is experienced professionals with established, industry-proven, yet flexible and adaptable processes. This is our experience of working with Safehand, and in particular Lucy, our Clinical Safety Officer. She has quickly become a valued and valuable member of the team, who continues to guide us through what without her could easily be overwhelming, time-consuming and therefore costly processes to meet the standards. Knowledgeable and efficient, Lucy has also been friendly and open to our thoughts and suggestions where appropriate. I would not hesitate in recommending Safehand to other companies in similar circumstances.

Clinical safety has always been central to our Theseus health and wellbeing platform’s development and it’s essential for our company to be compliant with DCB0129. Engaging with Safehand was a straightforward decision based on the company’s track record in clinical safety. We have been very impressed with our Clinical Safety Officer’s experience, knowledge and approachability in helping us develop and maintain our Clinical Safety Management System.

We found Safehand to be an excellent organisation to work with when completing our DCB0129. They demonstrated their experience and a breadth and depth of knowledge, which when coupled with their ability to communicate complicated issues clearly, made what could have been a difficult process very manageable. We wouldn’t hesitate in recommending them to any other organisation looking for a competent CSO.

"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."

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

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!

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.

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.

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.