Our objective is to support Health Organisations in the challenges they face implementing digital health systems from regulatory compliance to strategic deployment across ICBs.
By assisting digital health manufacturers in the reduction of risk in relation to the design and development of digital health systems, we are creating a safer environment for the delivery of care.
Passionate about
patient safety.
One of the biggest reasons I am so passionate about patient safety is because I have been affected by its consequence on a personal level and have seen what can happen if we do not pay attention to the detail.
We need to step into the shoes of our patients once and a while to see how they can and have been affected by clinical errors or never events that frankly cannot be excused.
The continued improvement in healthcare embracing patient safety, technology, effective communication, and collaborative teamwork will bring the healthcare community into a better place.
DPM Digital Health want to be a part of this journey in any way we can using our years of experience to create an environment in which we can deliver safer patient care to our growing population in which we are all patients.
Dean Mawson – Clinical Director / Founder
I have spent the last 31 years in the healthcare sector as a practicing Clinician and a Health Informatician, for 18 of these, gaining knowledge and experience in clinical practice, management and digital health systems.
I started my journey in digital health when I became clinical lead for a project to deploy an EPR into my Trust. I started to take a look at what we do and why we do it as healthcare professionals with the ultimate aim of making sure our patients are safe!
I then joined a leading digital health supplier and played an important role in the Clinical Risk Management, development and delivery of a PAS/EPR digital health system focused on the acute setting.
My journey continued becoming an independent Clinical Safety Officer (CSO) supporting the digital health sector suppliers and health organisations with their regulatory compliance. I have dedicated some of my time to mentorship, giving advice and guidance and becoming a Fellow of the Faculty of Clinical Informatics for which I sit on the Clinical Safety Special Interest Group.
This allows me to influence legislation and process at a national level to improve competencies and the delivery of effective regulatory activities.
The continued improvement in healthcare embracing patient safety, technology, effective communication, team work and good old-fashioned common sense will improve the delivery of care. DPM Digital Health are a part of this journey working collaboratively using years of experience to create an environment in which we can deliver safer patient care to our growing population supported by digital health.
Sonya Mawson – Company Secretary/Administrator
Sonya has over 30 years experience working in the banking sector in many roles including cashier, customer liaison, managerial support with highly effective communication, leadership and problem solving skills she brings a fresh pair of eyes into the healthcare sector. She has a clear understanding of the challenges and first hand knowledge of the working practices of the NHS.
DPM Digital Health works with a variety of partners to ensure a consistently high standard of practice in relation to regulatory compliance and collaborative team working.
Associates.
Dr. Tom Bradshaw – GP & Clinical Safety Officer
As a GP, practicing within the West and North Yorkshire regions, Tom has a passion for primary care and the role that innovative and emerging digital technologies have in the evolution of healthcare within the UK. He has a wealth of experience within the health and social care sector, spanning sixteen years in both community and hospital practice within the NHS and independent organisations, and is all too familiar with the complexity of the issues facing clinical practice.
As an accredited Clinical Safety Officer, Tom recognises the challenges that the DCB 0129 and 0160 regulations present. With his extensive clinical experience, he has an in-depth understanding of the risk management requirements of the NHS and the evolving needs of the health and social care sector as a whole.
He is passionate about improving patient experiences and outcomes whilst keeping patient safety at the forefront of developmental processes. Tom’s holistic and compassionate approach to patient care is mirrored in his care for his clients, where he thrives on nurturing quality and meaningful relationships throughout the DCB regulatory journey and beyond.
Tom plays an active role in the dynamic Leeds Digital Health Community and the Faculty of Clinical Informatics, alongside being a certified Member of the Royal College of General Practitioners and graduate of the NHS leadership program.
Brett Marshall – Deviceology
With over a quarter-century of experience in the health and med-tech sector, Brett is a well-established authority on Medical Device Regulations, Market Access, Information and Cyber Security, and the emerging field of Artificial Intelligence. His expertise is extensive, covering compliance with international standards such as ISO 9001, ISO 27001, ISO 13485, and ISO 14971, and adeptness with regulatory frameworks including the UK MDR, EU MDR, ANVISA in Brazil, TGA in Australia, and Canadian regulations. Additionally, Brett has extensive experience with the UK’s Digital Technology Assessment Criteria (DTAC), the Data Security and Protection (DSP) Toolkit, and Cyber Essentials, further enhancing his ability to support clients in their regulatory and standards compliance endeavors.
In his current role, Brett is deeply immersed in the evolving landscape of AI Regulation, with a focus on its integration within Medical Devices in the healthcare sectors of the UK, US, Brazil, Canada, and the EU. He is committed to navigating the ethical and practical challenges of Artificial General Intelligence (AGI) in medical devices, ensuring they align with complex regulatory standards and market access strategies. Enhancing his theoretical knowledge, Brett is also participating in the Artificial Intelligence Concepts and Practical Applications course at the University of Oxford. As a co-founder of Deviceology Ltd, he is instrumental in guiding start-ups and scale-ups through complex regulatory pathways, ensuring a seamless journey from concept to market.
Richard Bunney – Deviceology
Richard has 25 years experience in regulatory compliance, risk management, quality management, internal audit and cybersecurity, He has worked extensively with clients to demonstrate DTAC compliance, integrate applications with NHS APIs including NHS Login, care identity services and messaging exchange systems. An affiliate member of the Business Continuity Institute, Richard is a certified quality management auditor and holds PRINCE2, ITIL, CRISC, CISA and CDPSE (Certified Data Privacy Solution Engineer) designations.
He has previously worked as Head of Technology Internal Audit in the NHS and FTSE100 organisations leading teams and providing assurance on process and technical risks.
Catherine Corbett – Clinical Safety Officer
Catherine is a registered general nurse with 20 years of experience. She has worked in a variety of nursing leadership roles across healthcare including digital transformation projects, clinical informatics and clinical safety. Catherine has experience working in different countries including Ireland, Dubai, Saudi Arabia and the United Kingdom. Most recently, she worked for Nuffield Health as the Clinical Transformation Lead and Clinical Safety Officer (CSO) for their National Electronic Patient Record Project.
She has helped develop tools, strategies and methods to ensure site readiness pre deployment. She is passionate about preparing sites pre deployment. She believes adopting a proactive approach with sites is key at this crucial phase. She believes that early engagement, change management, benefits realisation, site ownership and robust training are key factors to ensure a successful digital transformation journey.
In her role as the Clinical Safety Officer (CSO), she led the development, definition and documentation of the Clinical Risk Management processes for the EPR Project. Catherine led the establishment and maintenance of the DCB 0160 standard documentation. She assisted in creating robust test scripts, testing approaches, supported key clinical testing during system upgrades and during live service.
Catherine is also a sustainability champion who is passionate about the positive effects digital transformation can have not only on the planet but also in turn for patients and their health. She was fortunate to be awarded a place on the inaugural Green Leadership Programme with the Florence Nightingale Foundation which she completed in 2023. She is also a mentor for the current Green Leadership Programme with the Florence Nightingale Foundation.
One size does
not fit all
One size does not fit all and this realisation has brought forward a change in attitude and mindset to create interoperable systems that communicate with each other to create a platform from which to grow.
With this comes a responsibility in making sure all systems are risk averse and comply with the NHS safety standards DCB0129/DCB0160.
Since 2008 I have had a collaborative relationship with the NHSE digital clinical safety team who have supported and guided me through the clinical risk management process both with the National and European standards giving me a solid platform on which I have developed my skills and gained experience managing numerous digital health projects in relation to clinical safety as a CSO and clinical specialist working alongside other SMEs in the digital health sector.
We have a collaborative approach to regulatory compliance making sure that we establish a relationship with our clients. This allows for a team effort which utilises a collective expertise on both sides to accomplish compliance and embed process within any organisation that is sustainable.
Dean is reliable, organised and knowledgeable but also flexible and pragmatic in his approach. Dean’s experience enables him to provide valuable insights into helping our teams embed processes and frameworks to ensure ongoing compliance to DCB0129, ISO 13485 and DTAC.
I’m confident that Dean will surpass your expectations as an independent CSO. Dean is driven, self-confident, proactively helpful, and passionate about patient/clinical safety.
Dean’s professional and honest approach coupled with his experience, knowledge and clinical background has enabled us build an effective partnership for achieving our respective DCB0160 and DCB0129 commitments.
Our go live passed with minimal new clinical risks identified. Due to Dean's expertise and help, most risks had already been anticipated and mitigated through the clinical safety process in advance.
“As a HealthTech organisation serving the NHS, correctly navigating the clinical safety regulations is paramount. Dean at DPM Digital Health Consultancy made this entire process seamless with easy to understand guidance and advice. We are now fully DTAC compliant and looking forward to a long and fruitful relationship with the team.”
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Simply fill out the form and we’ll get back to you as soon as we can. Alternatively, give us a call on 07840 049772 or email dean.mawson@dpmdigitalhealth.co.uk
