DTAC Support and Clinical Risk Management (DCB0129)
We support organisations in navigating NHS DTAC requirements and implementing clinical risk management in line with DCB0129. Our focus is on building practical systems that align with how your organisation operates and stand up to regulatory scrutiny.
DTAC (Digital Technology Assessment Criteria) is a key requirement for organisations looking to work with the NHS. It brings together standards across clinical safety, data protection, technical assurance, and usability.
Alongside DTAC, clinical risk management in line with DCB0129 is essential for digital health products. This ensures that risks to patients are identified, assessed, and managed appropriately.
Many organisations find that requirements overlap across DTAC, ISO standards, and medical device regulation. Without a structured approach, this can lead to duplication and confusion.
We focus on building a joined-up, practical approach that aligns DTAC and clinical risk requirements into a clear, manageable system.
Zara Malik
DTAC Support
We support organisations through the DTAC process in a structured and practical way.
We work directly through the NHS DTAC checklist with you. This ensures that each requirement is properly understood, applied, and evidenced.
The focus is on building a submission that reflects your organisation, rather than forcing your processes into a pre-defined format.
In most cases, organisations already have elements of DTAC in place.
We begin with a gap analysis to assess your current position against DTAC requirements. This includes:
This provides a clear, structured view of what needs to be addressed.
Where requirements are not yet met, we support you in building them properly.
This includes:
The aim is to produce a complete and coherent DTAC submission that stands up to NHS review.
Implementation of DCB0129 Clinical Risk Management
We support the full implementation of clinical risk management in line with DCB0129.
This includes establishing the Clinical Safety Risk Management File and ensuring that appropriate processes are in place to identify, assess, and manage risks throughout the product lifecycle.
Our approach ensures that clinical safety is embedded into your organisation, rather than treated as a standalone activity.
Where your product falls under medical device regulation, clinical risk management must align with ISO 14971.
We ensure that your clinical safety processes and product risk management are consistent and integrated. This avoids duplication and supports a more efficient regulatory approach.
The result is a single, coherent risk framework that meets both NHS and regulatory expectations.
We work closely with your Clinical Safety Officer (CSO) to develop and maintain key documentation.
This includes:
Our approach is focused on building systems that are:
Related Support
DTAC and clinical risk management often sit alongside wider compliance requirements. We also support organisations with:
If you are preparing for DTAC, implementing DCB0129 clinical risk management, or aligning your systems with NHS and regulatory requirements, we can support you at any stage.
Contact us to discuss your current position and the most practical next steps.
Our extensive experience and success stories demonstrate our capabilities. We have helped numerous clients navigate the complex regulatory landscape, ensuring their devices remain compliant and perform optimally in the market.
Our proven track record of successful evaluations and satisfied clients is a testament to our expertise and commitment to excellence.
Our team is here to help.
Fill out the contact form to get started, and let us guide you through the complexities of biological evaluation with confidence.
