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.

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.

I would like to take the time to commend Safehand in general, and particularly Oyinkan for an outstanding job in helping the HomeSight solution get to DCB 0129 compliance satisfactorily. Oyinkan was thorough, and exercised awesome due diligence during the entire process, and the remarkable thing is that through her logical thought process and presenting material, always with “why an evidence, or control, or a process is required”, helped us to refine our thinking to bring in a “Clinical Safety” mindset and angle to whatever we do. While we had to work harder to fill the gaps in our documentation, processes and test scripts, we were doing it with vigour knowing that all these contribute to a stronger solution that can stand proud in the market.

Oyinkan is an absolute asset, and a real pleasure to work with. She put us at ease, while politely being firm on the requirements as should be the case. We are happy to retain her as the CSO and we are very pleased with Safehand in terms of the engagement.

"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 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.

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.

“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.”

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.

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.

“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.”