"In a digital health business, we need to work with people who are domain experts who can simplify complex challenges and are great at listening to new ideas and alternative viewpoints. Whether its Medical Device compliance or DCB0129, Safehand just get the job done and deliver what they say they will."

As a leading provider of medical devices and digital health solutions, patient safety and clinical compliance are of utmost importance to Mindray. Partnering with Safehand to navigate the regulatory clinical safety environment has been invaluable in achieving accreditation and ensuring the care of our customers and users. Lucy has guided us expertly and rapidly throughout the process, offering considerable insight. Her experience and dedication to our goals have helped the team at Mindray build our understanding and commitment to clinical risk management. We look forward to our continued collaboration with Lucy and Safehand as we develop and enhance our solutions.

"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."

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.

When we first started looking at DCB0129 compliance I didn’t know whether to think “this looks really simple, what’s the problem” or ” this is so complicated I don’t know how we can manage it”. On our first contact with Safehand, it turns out I was right on both counts. It is really complex! And then we met Lucy, our CSO. Right from the start, she worked with us to break the complicated process of a Clinical Safety Review of our BEST system down into simple bite-sized chunks. Her expert eye was able to separate the important from the trivial and then put in place a process that allowed us to address the requirements of the Standard in a logical way that made it easy to understand what was needed. We now have a Hazard Log that identifies the Clinical Risks, demonstrates the controls we have in place to mitigate these, and an excellently-written Clinical Safety Case report. Not only has Lucy enabled us to meet DCB0129, but also given us insight into how we can work in the future to further improve our products.

"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."

"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."

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.

As an emerging digital agency venturing into healthcare software products, we found ourselves trying to navigate the complexities of the world of Clinical Safety and DCB0129 compliance. Safehand has proved to be an invaluable partner in this journey. Their meticulous approach and commitment to understanding our product ensures our compliance is robust and fit for purpose. Our nominated CSO, Lisa, guides us every step of the way, instilling the utmost confidence in us. We highly recommend Safehand for their professionalism, dedication, and expertise.

"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."