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.

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 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.”

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.

Mobio Interactive is extremely pleased with the diligence and efficiency provided by Safehand. In particular, Natalie Hall has been the Clinical Safety Officer for our digital therapeutic platform AmDTx for over a year. In that time she has guided our team through the entire DCB 0129 certification process, as well as contributing meaningfully to the platform development and overall regulatory and certification strategy. We look forward to an ongoing partnership ensuring the clinical safety of all our digital interventions for mental health and CNS disorders.

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.

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.

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.

“Working with Safehand has been a breath of fresh air in what can be a complex and detailed area. We are a very fast moving health tech company with a release schedule we work hard to maintain. Safehand have consistently demonstrated that they understand our process and are willing to work with us. They challenge us where appropriate but understand us, our culture and our mission. We feel confident that Safehand isn’t just offering us a cookie cutter service but it is truly bespoke. Everyone on the Safehand team is a delight to work with and incredibly knowledgeable. I would not hesitate to recommend them to anyone."

As a leading supplier of critical Emergency and non-emergency Ambulance systems, our focus is always to deliver clinically safe and compliant systems and functionality to our customers. In partnership with the expert and knowledgeable team at Safehand, we have been able to ensure compliance with DCB0129 across all our platforms. The team at Safehand have a unique understanding of the challenges that supplier organisations face in the ever-challenging digital world. Their approach is one of collaborative working, creating all the required documentation, providing clear and constructive feedback and advice, and supporting the overall process as a critical friend. Understanding that Clinical Safety is an on-going process, Safehand are now further supporting us with embedding Clinical Safety into the heart of our culture.