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.
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.
Safehand have provided us with the expertise, guidance and support to develop a robust clinical safety strategy as a mental health organisation. We started at the very beginning of what would have been a very overwhelming clinical safety journey with Safehand. They have supported us with compliance training, policy development, Board awareness and more. They have been consistently professional, diligent and adaptable along the way. Whilst our internal governance and expertise in this domain has now strengthened, we continue to be grateful for the insights and expertise that Safehand continue to offer.
Blythe was exceptional to work with. Her knowledge and expertise helped us navigate through a complex and unknown path with ease and reassurance. Blythe's pragmatic approach helped us at a stressful time and really helped alleviate any additional stress. We are delighted to continue working with Blythe.
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.
"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."
Although we had the existing artefacts and processes in place to be compliant with DCB0129, Safehand provided their specialist expertise to add structure to our clinical safety documentation and streamline the relevant processes. In addition, their continued support through providing an experienced Clinical Safety Officer ensures we maintain our adherence with the standards as we onboard additional customers and the product(s) evolve.
We contacted Safehand as we needed an experienced partner and specialist to guide us through our DCB0129 assessment for our patient and general practitioner apps with confidence. Safehand worked hand in hand with us to understand and assess our product and processes, providing all the necessary templates along the way. Having gone through the assessment, we’re now in a much better position and able to incorporate clinical safety into our requirements gathering process, and identify any areas for improvement, with Safehand supporting us along the way. Thank you for all your support and expertise Michelle and Adrian.
Look no further than Safehand for your DCB0129 needs. From the outset the experience and expertise of the Safehand team was clearly demonstrated. Eric Bulwer our Safehand Clinical Safety Officer consultant is very much part of Clinical Computing UK Ltd adding very valuable insights and perspective.
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.
Safehand have been superb in supporting us through the launch of a new medical device and ensuring ongoing compliance with DCB0129 as well as giving excellent advice on the broader aspects of medical device regulation. Thank you Adrian and Hadi.
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.
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.
“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.”
Considering the size and scale of the project, and how much our CSO Lucy Birks had to pick up in a very short period, it was an enormous task done quickly and efficiently. The guidance directing future tasks to ensure compliance continues are also beneficial for us in continuing the clinical safety principles.
The Safehand team was professional, informative, and extremely helpful in every aspect of its work with MLCSU. The expertise of Safehand clinical safety officers was invaluable to us in setting up our digital safety compliance processes, from support in writing policy, to advice in dealing with complex issues, and their regulatory experience enabled us to avoid some of the pitfalls of DCB 0129 and 0160 compliance work.
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.
"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."
Safehand were incredibly helpful and professional throughout the whole process of ensuring we are compliant with DCB0129. We are really happy with the documentation they produced and have received excellent feedback from our clients as a result. Thank you Adrian and Hadi.
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!
"Thank you so much for all your help. You've been fantastic and I am absolutely delighted with the process and report."
"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"
I wholeheartedly recommend Safehand for their outstanding support during our recent experience with them working on the DCB0129 for one of our solutions. Their expertise was invaluable in navigating the complexities of DCB0129 compliance and ensuring we met all regulatory requirements. They provided exceptional guidance and went above and beyond to address our questions, offering insightful advice on the broader landscape of the different regulations. I would like to make a special mention of Lucy Birks, our appointed Clinical Safety Officer who has guided us expertly and rapidly throughout the process. A huge thank you to the entire team, especially Lucy, Adrian, and Amanda, for their dedication and partnership.
EIDO Healthcare have a history of providing high quality patient information to support informed consent in NHS and private hospitals. When we expanded into the digital healthcare space, we thought that Clinical Safety was something we could do ourselves…how wrong we were! Luckily we asked Safehand for help and they appointed Natalie as our Clinical Safety Officer. She expertly guided us through the DCB0129 process with extensive regulatory knowledge, rationality and common sense. We have a retained services agreement with Safehand and enjoy having a CSO on our team.
There is so much to unpack around clinical safety and DCB0129/DCB0160 compliance. Before working with Safehand this was a painfully complex space which organisationally we knew little about. We found it challenging to understand the processes and ways to implement across our organisation. Fast forward and with their help we are making inroads and for all the right reasons.
Safehand have made the experience genuinely positive, interesting and engaging - those are words that I never thought I would use to describe our approach to 'clinical safety'. Marvellously talented people and very kind at heart. A pleasure to work with. There is a reason they have such a good reputation. If you are stuck with clinical safety, give them a call today.
“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.”
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.
"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."
At Log my Care, ensuring compliance with NHS clinical safety standards was paramount and partnering with Safehand provided us with the expert guidance needed to navigate the complexities of DCB 0129. Their team's deep understanding and practical approach made the process seamless, allowing us to integrate safety into every facet of our platform. Thanks to Safehand, we achieved compliance swiftly and efficiently.
Safehand recently supported us on a digital project and Lisa, our designated CSO, demonstrated exceptional digital clinical safety knowledge and skills. She expertly guided us through the process and was incredibly agile in responding to our requirements. Her proactive approach and clear communication made the experience seamless and stress-free. We highly recommend Lisa and the Safehand team for their outstanding services.
I'd like to thank Safehand for supporting PocDoc in creating our clinical risk management deliverables for our DTAC assessment and GP Connect onboarding. The Safehand onboarding process was simple and thorough, which meant we could quickly move from briefing to implementation. Safehand has made the process of becoming DCB 0129 compliant straightforward. I would like to make a special mention of Lucy Birks, our appointed Clinical Safety Officer. Lucy has guided us expertly and rapidly throughout the process and offered considerable insight. Her experience and dedication to our aims, has helped the senior management team at PocDoc to build our understanding and commitment to clinical risk management.
"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."
Alex Honour played a pivotal role in the successful delivery of our digital clinical safety case for the implementation of a Trust-wide, first-of-type Patient Administration System (PAS). This was an incredibly complex and high-stakes programme, involving not only a significant data migration effort, but also a major shift in working practices for thousands of staff across clinical and operational teams.
Throughout the project, Alex was thorough, approachable, and highly professional—bringing clarity and confidence to a challenging piece of work. What stood out most was Alex’s unwavering commitment to patient safety, which was evident in every question asked, every challenge raised, and every task undertaken.
Alex worked closely with our own Clinical Safety Team and has imparted knowledge and skills for them to carry forward into future projects.
The result was a comprehensive safety case that not only met immediate programme needs but also laid strong foundations for ongoing assurance as the system is further embedded and optimised.
In our line of work at Lenus Health, where we are at the forefront of medical device innovation, safety isn’t just a priority; it’s the foundation of everything we do. Initially, the detailed requirements of DCB0129 and DCB0160 standards seemed daunting. That’s where Safehand, and specifically Natalie, stepped in and transformed our trajectory towards compliance, ensuring our products meet the highest safety standards efficiently and effectively. This partnership has not only been beneficial but genuinely enjoyable, thanks to their professional yet warm approach. We’re grateful for the journey with Safehand so far and are excited for what lies ahead, knowing we have a reliable guide in them.
Working with Safehand has been a pleasure from first contact with their Managing Director regarding developing a suite of documentation to ensure compliance with DCB0129 to our ongoing relationship with our Clinical Safety Officer contracted via Safehand. They not only have an excellent understanding of the legislative requirements, but have broad experience and knowledge of the healthcare sector which has helped us painlessly navigate our way through what is a complex process and requirement.
"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."
It has been a pleasure, thank you for all your technical expertise, patience and approachability – it has been really appreciated and helped this to get over the line.
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.
Southern Health NHS Foundation Trust want to express our thanks to Shelley for her exceptional dedication and hard work in supporting us with the clinical risk assessment of our embedded EPR. Having been in place since 2011, the EPR is a crucial component of our healthcare delivery, and Shelley's efforts have been integral to ensuring that our processes remain robust. Thanks to her commitment, our EPR is now DCB0160 compliant. Her contributions have had a significant impact on the effectiveness of our system, and we are truly grateful for her support and for Safehand for making this possible.
We are dedicated to protecting staff, patients, and the public, striving to exceed safety standards for all our users. Thank you to Louise Caney at Safehand and our fantastic team who have made our DTAC compliance happen!
“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.”
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.
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.
Thank you so much for holding my hand whilst I walked through this mammoth project. I have learnt so much and achieved so much with you by my side. It really has been a collaborative partnership and one I have enjoyed.
We approached Safehand to provide the Clinical Safety guidance required to achieve DCB0129 compliance. We found Richard to be very approachable and professional, guiding us through the process in a clear and structured way. His expertise was instrumental in helping us navigate the complexities of the DCB0129 framework with confidence. Safehand acted as a trusted partner, and we are very grateful for their assistance in enabling us to achieve this critical milestone.
We are really grateful for Alex and Safehand's support in bringing NCL Waiting Room in compliance with DCB0129 and DCB0160. Having a CSO with experience working in Child and Adolescent Mental Health Service (CAMHS) was hugely valuable. Our work with Safehand brought a new degree of rigour to the governance we bring to the platform – not just in terms of what appears on the screen, but also the work we do off-screen in terms of management and safety.
"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."
“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 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.
"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."
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.
"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."
When we contacted Safehand early in 2023, we needed help with the complexities of DCB0129. Safehand has proven to be an excellent partner to work with. Small companies like us find it difficult to find the resources to manage compliance and Safehand have accomplished this for us and ensured that our processes are up to the mark. Many thanks Adrian and Lucy.
More than just his knowledge of the DCB0129 process we were really impressed with how Dean got under the bonnet of our product, understood what we are trying to achieve, carefully considered our users, and quickly felt like an invaluable member of our team. Whether on our regular remote check in calls, in a face to face workshop with our clinicians, or his record keeping and correspondence, Dean’s clarity of communication saved us time and kept us on course. Our product improved and our knowledge expanded through this process and we look forward to working with Safehand over the years ahead.
We were very pleased with the engagement process and the quality of deliverables and outcomes in what was a testing timeframe. Lucy provided expert guidance and advice and was instrumental in ensuring a successful result. We would certainly recommend Safehand if you wish to outsource your CSO requirements.
As a leading provider of clinically validated digital treatments, patient safety and clinical compliance are of paramount importance to Mahana. Having Safehand performing an independent Clinical Safety function ensures our rigorous adherence to DCB0129 requirements as well as helping us to ensure we are offering patients therapy that they can trust to be safe and effective. An excellent partnership.
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 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.”
Safehand has been a trusted advisor and partner in our DCB0129 compliance process, as well as in providing broader guidance on software as a medical device for Bliksund EWA, our digital record solution for emergency professionals. Their team has demonstrated deep expertise, offering clear and pragmatic advice that integrates seamlessly into our operational approach. Their reliability and ability to simplify complex regulatory requirements have made the entire process smooth and efficient. Safehand's knowledge, professionalism, and practical mindset make them a pleasure to work with, and we highly recommend them to any organisation navigating the landscape of medical regulations and software.
Partnering with Safehand to navigate the regulatory clinical safety environment has been invaluable in achieving accreditation and assuring the care of our customers and users. Lucy's deep knowledge and expertise, as well as her willingness to work within our project management and other systems, have made a complex and daunting process, straightforward and smooth. We will definitely be keeping our new CSO in our corner going forward!
“Safehand have professionally steered us through the complex process of being DCB0160 compliant for our Shared Care Record. Safehand's, knowledge and guidance along with their practical approach enabled us to assess the current position, adapt and improve along the journey. Thank you for up skilling the Team in knowledge and we look forward to working with Safehand in the future.”
"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.”
Working with Safehand Consulting has been positive and supportive. The OneLondon eMHA programme was complex - spanning multiple NHS and social care organisations, all working together to digitise the Mental Health Act. Safehand provided well-planned, pragmatic, thorough, and very professional clinical safety oversight and delivery for OneLondon. We recommend their highly skilled and expert guidance and the positive working relationships that they established. They played a vital role in helping us introduce the new digital system that is now supporting safer, faster, and more joined up mental healthcare in London. Safehand genuinely works with you, ensuring clinical safety compliance is achieved and embedded. Thank you!
The experience held by Safehand and their clear expertise in clinical safety and health tech has been fundamental in reaching DCB0129 compliance. Safehand’s impact has been much wider than just compliance, it has woven clinical safety into all aspects of our product design, development, delivery and support. Safehand’s ability to rapidly understand the product, and how it is utilised in the real world is refreshing. The expertise brought by the team at Safehand has brought benefits not only to our organisation but every customer who uses an Inform Health product.
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.
"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."
Working with Safehand on our DCB0129 compliance was straightforward. The process was well established and robust. Our allocated CSO was an expert with real-world experience in our field and was able to quickly understand the product and its applications. We are very happy with the flexibility in supporting ongoing compliance.
We engaged with Safehand to guide us through DCB 0129 and MHRA compliancy. They are also operating as our CSO. The working relationship is excellent and their guidance has meant we are confident that we are fully compliant in both areas.
Working with Safehand Consulting, and particularly our Clinical Safety Officer Lucy Birks, has been an outstanding experience. Lucy has been phenomenally helpful—pragmatic, calm, and highly skilled at rationalising and simplifying complex regulatory processes. She integrates into our ways of working, providing expert guidance without adding unnecessary burden. Safehand is a consulting firm that genuinely works with you, not just for you, ensuring clinical safety compliance is both achievable and embedded effectively within our organisation. We are grateful for their expertise and ongoing support.
"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."
Massive thank you to all the wonderful folks at Safehand for their help getting Tellmi DCB1029 compliant. Their expertise and advice was invaluable during the whole process. Clinical safety is a difficult and complex process but thanks to the cool heads at Safehand it isn't remotely daunting. We'd recommend them to anyone without hesitation!
We approached more than one company for advice about our service and its DTAC obligations; Su and Natalie walked us through the DCB 0129 process and gave us advice that was in our company's best interest. They took the time to listen to us, work through our system, and present us with a detailed and professional report to address any future issues or individuals doubtful about BCS's DCB 0129 obligations. I recommend Safehand for DTAC and DCB 0129 advice and support.
It’s been hugely valuable working with Safehand on the DCB0160 clinical safety case for the OneLondon eMHA by Thalamos programme. East London NHS Foundation Trust was the first of the London Trusts to go live with this new system, and thank you to Alex Christie and Safehand for developing a detailed and thorough safety case in collaboration with key stakeholder which provided essential assurance that hazards were effectively identified and significant risks mitigated in preparation for our go-live.
“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.”
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.