“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.”  Read the case study...

Iain Mackenzie, InterSystems Clinical Safety Officer

"In completing the work supported by Safehand and its detailed knowledge it has also allowed us to integrate the safety processes in to our existing Quality Management system (ISO 9001/2015) allowing us to better manage the risk of software change going forward.” Read the case study...

John Hopkins, Med eTrax Chief Executive

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

Fiona Steven, CEO Know As You Go

"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."

Steve Treadwell, Silicon Practice Director

"We found our Safehand consultant to be extremely competent and knowledgeable and able to very quickly assimilate what our product was about.  We were pleasantly surprised how Safehand chose to make use of our own tools and ways of doing things. In building our Hazard Log and Safety Case, they didn’t try to re-invent the wheel or burden us with unnecessary paperwork."

Syd Stewart, 4S Dawn Managing Director

"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."

Roko Malkoč, Better by Marand OPENeP Product Manager

"Safehand has made the process of becoming DCB 0129 compliant straightforward. The templates and tools available with Safehand are well considered and very useful. For example having a starting point for creating a Hazard Log and Safety Case meant we could get started quickly. Our Safehand CSO has excellent industry knowledge which is invaluable when working with complicated situations, customers and deliverables. Safehand worked with us to improve our existing processes with minimum impact on day to day operations. We feel that we have the tools and support to maintain our accreditation, and to work on development knowing our process is right, and the product safe for users."

Corinna Dymond, Sitekit

"We've worked with Safehand right from the start of our journey with DCB0129 compliance. It has made so much sense to have the experts guiding us, producing all the documentation and available to help with all the hard questions. Thank you Adrian and Julia."

AskMyGP

“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.”

FDS Dental Referrals, Anne Lamb Director of Operations

“Before we worked with Safehand we knew we weren’t compliant with DCB0129 and DCB0160 but we’d found it challenging to get the time to get all the necessary documentation together and embed it within our organisation. With their help we were able to accelerate our compliance strategy and straight-forwardly build all the necessary documentation to comply.
What I like about the Safehand approach is that they are keen to work with us rather than against us. We were concerned about the level of work that would be generated by the process, and that they’d tell us that we need to do everything differently but instead they moulded their approach to how we do things here, and offered pragmatic advice on how to deal with any non-compliant areas.”

Tracy Gardiner, Ideagen Group Project Services Manager

“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."

Chris Eldridge, Mayden Director of Operations

“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.”

Andy Crowther-Green, Terrafix Ltd Sales Director

"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."

Yachna Tak CEO

"Safehand was recommended to us by one of our advisors. As a healthtech startup we were looking for sensible strategic advice regarding the complex and evolving world of medical device regulation. Safehand were able to provide this and also made us aware of the requirement for DCB 0129. They are easy to work, quick to respond and thanks to their honest and straight talking advice we now comply with the necessary regulation"

Peter Grinbergs, EQL CMO & Co-Founder

"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."

Caroline Gadd, Director, MaST

"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."

Taz Aldawoud CEO, Doc Abode

"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."

Chris Ryan, Video Consulting Programmes Director, Attend Anywhere

“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.”

Paul Stevens