Governance, Safety & Cyber Security for Healthcare Innovators

We work with digital health and AI companies who need to meet clinical, regulatory and cyber security expectations — without slowing down innovation.

From DCB0129 and AI governance to Cyber Essentials and penetration testing, we help you meet healthcare standards in a way that supports growth rather than obstructs it.

Talk to a Governance Specialist

Built for Healthcare Technology Companies

We support organisations developing technology that interacts with clinical workflows, patient data or NHS systems.

We typically work with

    HealthTech and MedTech startups

    AI-enabled healthcare platforms

    Digital health suppliers preparing for NHS engagement

    Early-stage companies seeking enterprise credibility

Our core services

DTAC Management

End-to-end management of the Digital Technology Assessment Criteria (DTAC).

Clinical Safety & DCB0129

If your product affects clinical decision-making or care delivery, clinical safety is non-negotiable.

AI Governance

AI in healthcare demands accountability.

Information Governance

Healthcare organisations need confidence in how you handle data.

Cyber Essentials

Guided certification aligned with supplier expectations.

Penetration Testing

Independent security testing to identify vulnerabilities before procurement or due diligence.

Digitrace is not a general compliance consultancy.

We focus exclusively on healthcare governance, clinical safety and cyber assurance.

Our role is simple:

  • Clarify what applies to you
  • Structure your compliance properly
  • Close gaps early
  • Present evidence clearly
  • Support you through scrutiny

The outcome is credibility — with regulators, procurement teams, partners and investors.

Talk to a Governance Specialist