0113 873 0019





Digital Health & Clinical Safety Specialists providing Clinical Risk Management Services, DTAC Compliance, Consultancy and more.

DigiSafe provides a dedicated, honest and professional service, with not only the client but the end user and person at the centre of all we do. 

Let us help you on your cosmic quest. 



DigiSafe was founded with a clear mission: 

Provide expertise to assist and support those in need with compliance, organisational & deployment challenges.

We are dedicated to supporting Health IT manufacturers, including software and app developers, as well as Health and Care Organisations, in meeting their Clinical Safety Assurance and Compliance requirements.

At DigiSafe, we stand ready to accompany you on your journey. Whether it’s completing the DSP toolkit, providing DTAC compliance services, facilitating Medical Device registration, or developing the essential DCB0129 and DCB0160 Clinical Safety core document set, we’re here to help.

With a wealth of experience in these specialised fields, DigiSafe brings the expertise, knowledge, and capabilities essential for ensuring that our clients’ needs are not only met but exceeded, all while adhering to stringent regulatory and national standards.


Clinical Risk Management: its Application in the Manufacture of Health IT Systems 


Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems

With a wealth of experience in these specialised fields, DigiSafe brings the expertise, knowledge, and capabilities essential for ensuring that our clients’ needs are not only met but exceeded, all while adhering to stringent regulatory and national standards. 

We place particular emphasis on the pivotal Clinical Safety Standards DCB0129 and DCB0160, integral components of DTAC. However, offer the full package when it comes to Organisational Governance and Programme Deployments.

We firmly believe that true governance goes beyond checking a box or doing it once, educating the workforce, inspiring the next generation, offering mentorship, guidance, training and support is a big part of what we do, and what we do well.

We believe embedding the processes with the people is key.


Clinical Risk Management

We collaborate with Health IT Manufacturers, whether they are large corporations or small enterprises, to ensure compliance with mandated standards. 

Our services encompass various aspects, including completing comprehensive product documentation, conducting hazard assessments, and providing feedback on digital readiness and overall product safety.


Clinical Risk Management

In the realm of healthcare technology, ensuring patient safety and the effective deployment of Health IT Systems is paramount. 

The DCB0160 Clinical Risk Management standard serves as a guiding framework for healthcare organisations to mitigate risks associated with the deployment and use of Health IT systems, software and apps. 

Compliance with the standards is more than a regulatory requirement, it’s a driver to deliver healthcare solutions that prioritise patient well-being, assist workforces, while ensuring no increased harm comes to the patient. It also signifies a commitment to transparency, accountability, and the continuous improvement of healthcare technology.


We believe sharing knowledge to enable the delivery of good quality health, care and service is key. We ensure the quality of what we produce is not only compliant with requirements but understandable, transparent with clear outcomes and recommendations.

Our array of Digital Health Specialists aim to achieve the best results to ensure the assurance of safe, secure systems. Our goal is to embed the processes with the people to lead to success, not just in theory but within daily practice.

Digital enablement, Inclusion and Patient Safety is at the core of everything we do, the reason we are here to help you! 

With an understanding of the real-world challenges, local and national strategies for care provision, our team focuses their assessments on the delivery to individuals and end users. Covering all health and care sectors, national and international standards along with backgrounds in software engineering, data and programmes, our team will ensure your product, service, or deployment is delivered with the highest

Clinical Safety- DCB0129/DCB0160 compliance

  • Clinical Risk Management System (CRMS)
  • Clinical Risk Management Plan (CRMP)
  • Hazard Log (s) (HL)
  • Clinical Safety Case Report (CSCR)
  • Named Clinical Safety Officer

The items listed above are some of the requirements which manufacturers and deployers of Digital Health must conform with, in relation to the mandated Clinical

Risk Management standards. DigiSafe will work with your organisation and team(s) to ensure these key artefacts are completed to achieve compliance and ensure the product is clinically safe for deployment. Where is it not deemed safe then recommendations will be provided and an experience Clinical Safety Officer is available to support and guide you along every step of the way. 

A series of Hazard Workshops will be required with the team(s) and engagementthroughout the project expected. This is to ensure the documentation captures the true position of the product or deployment. Engagement is key. 

Assistance will also be provided in the DTAC process where required and on-going support offered in this regard. 


At DigiSafe, we understand that navigating the complex realm of compliance, particularly when it comes to the Digital Technology Assessment Criteria (DTAC),
can be a daunting task for software manufacturers, Innovators and for NHS organisations on the receiving hand of the assessments. However, it’s a journey that
cannot be overlooked or underestimated.

By partnering with DigiSafe, you not only ensure compliance with DTAC but also gain a competitive edge in the dynamic healthcare technology market. Our expertise,
dedication, and commitment to patient safety will help you navigate the compliance journey with confidence, ultimately delivering safer and more reliable digital health solutions. Our team of industry experts and specialists have over 100 years combined eperience in these complex domain areas. We support both
manufacturers and the NHS in completing and assessing the product and status.

Digisafe also supports the DTAC Squirrel – an AI compliance tool backed by experts.

Consultancy, Training, Mentorship

Our team of Digital Health Specialists boasts extensive experience across diverse realms of health, care, digital, programme management, software domains and more. Equipped with profound insights to accompany, advise, and steer you along your journey. 

Our commitmentis to provide support, offering an abundance of best practices and guidance on requirementsto ensure compliance, assurance, and enlightenment. By empowering teams to comprehend and implement these practices seamlessly into their daily endeavours.

 Our services encompass CPD accredited training, enlightening awareness sessions, and personalised mentorship and coaching opportunities for all.





Shared Care Record Summit 2024


We’d love to hear from you.

Simply give us a call on 0113 873 0019,
fill out the form,
or drop us an email.