DTAC Support

End-to-end support for securing NHS Digital Technology Assessment Criteria approvals — from initial gap analysis and evidence compilation to committee liaison and successful sign-off

How We Help

Comprehensive DTAC Support Services

Gap Analysis & Assessment

Evaluate your digital health technology against all five DTAC domains — Clinical Safety, Data Protection, Technical Assurance, Interoperability, and Usability — to build a clear compliance roadmap

Evidence & Documentation

Expert compilation of all required evidence packages — Clinical Safety Case, DPIA, technical specifications, interoperability attestations, and usability study reports — structured for swift review

Submission &
Committee Liaison

Guide your technology through the full DTAC submission process, responding to assessor queries and iterating on documentation to achieve a successful approval with minimal delays

About DTAC

Navigating the NHS Digital Technology Assessment Criteria

The Digital Technology Assessment Criteria (DTAC) is the NHS England framework for assessing digital health technologies before they can be deployed within NHS settings. Covering five key domains, DTAC ensures that apps, clinical decision support tools, and health information systems meet robust standards for patient safety, data protection, and technical interoperability.

ReguLogix Consulting offers comprehensive support from initial assessment through to successful approval, helping your technology satisfy each domain requirement and proceed to NHS deployment with confidence.

What We Cover

DTAC Domain Support

  • Clinical Safety assessment and Clinical Safety Case compilation (DCB0129 / DCB0160)
  • Data Protection Impact Assessment (DPIA) and GDPR compliance review
  • Technical assurance — architecture, security, and infrastructure documentation
  • Interoperability requirements and NHS integration evidence
  • Usability and accessibility compliance testing and documentation
  • Responding to assessor queries and iterating evidence packages
  • Post-approval maintenance and re-assessment support
MHRA Registered
Recognised regulatory authority compliance
Global Regulatory Reach
EU, UK, US, and international markets
End-to-End Service
From strategy through to market approval
ISO Aligned Approach
ISO 13485, ISO 27001 & GMP expertise

Get in Touch with Us

Discover the flexible ways you can engage with our services based on your company's specific requirements. 
We offer the following options, which can be customised to align perfectly with your business needs:

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

Book a Free 30 Minute Consultation

ReguLogix Consulting Ltd
AboutServicesContact

This site is governed solely by applicable laws and governmental regulations for England and Wales.
Use of this site constitutes your consent to application of such laws and regulations and to ourPrivacy Policy. Your use of the information on this site is subject to the terms of our  Legal Notice. Cookie Policy

Copyright © 2024 ReguLogix Consulting Limited. All Rights Reserved.