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

DigiSafe Consulting 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 for compliance.



DigiSafe was founded with a clear mission: 

Provide expertise to assist and support those in need with compliance 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 Consulting, 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.


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 Consulting 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.

We firmly believe that true compliance goes beyond checking a box or doing it once, educating the workforce, offering mentoring, guiding, training and support is a big part of what we do, and what we do well.

We offer consultancy to all, as 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.

Clinical Safety Documentation set for 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 above are required to conform with the clinical safety standards and the NHS developed DTAC process. These can easily be completed once a kick-off meeting has taken place, a demonstration (where applicable) has been provided and any relevant documentation and information gathered. 

A hazard workshop will be required with the team(s) and engagement throughout 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 Consulting, 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. However, it’s a journey that cannot be overlooked or underestimated.

By partnering with DigiSafe Consulting, 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.

DSP Toolkit

DSP Toolkit compliance is essential. It’s a comprehensive set of requirements and best practices aimed at safeguarding patient data, ensuring that sensitive information remains confidential, and protecting against data breaches and cyber threats.

Therefore, at DigiSafe Consulting, we recognise that achieving and maintaining DSP Toolkit compliance can be a complex and demanding task for software manufacturers. That’s why our team of experts is here to assist you every step of the way, ensuring that your digital health solutions meet and exceed DSP Toolkit requirements.

Consultancy, Training, Mentorship

Our Digital Health Specialists have years of experience in varied health, care and software environments, with in-depth knowledge ready to share, guide and lead you through your journey. 

We are here to support you with infinite amount of best practices and requirement advice which ensures compliance and assurance. We also offer CPD accredited FCI approved Clinical Safety Officer training


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

Our array of Digital Health Specialists aims to achieve the best results to ensure the assurance of a safe and secure system or product, as well as the deployment and implementation of these. Our goal is to embed the processes with the people to lead to success, not just in theory but within daily practice.

Person 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 and local and national strategies for care provision, our team focuses their assessments on the delivery to individuals and end users. From primary, secondary, and social care, along with backgrounds in software and national programs, our team will ensure your product, service, or deployment is safe for use.







We’d love to hear from you.

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Alternatively, give us a call on
07368 646214 or email