Get accessible, expert support for your health technology and regulatory approvals.

Our bespoke Clinical Safety Officers help health technology teams innovate quickly and fail safely.


We strengthen clinical governance and ensure regulatory readiness—so healthcare organisations can use technology with trust and scale with confidence.

Fractional

Clinical Safety Officers

for fast growth, safe deployment and compliant scaling.

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Why?

There are many reasons why bringing in a fractional Clinical Safety Officer (CSO) can transform your health technology organisation.
Here are some of the most common:

New Product Development

Building From Day One
We’ll help you embed safety into early design, map clinical risks, support DCB0129/0160 documentation, and ensure your product is safe-by-design before development accelerates.

Deployment

Launching Safely & Compliantly
We guide you through hazard logs, clinical risk assessments, governance sign-off, safety cases, and deployment readiness—so you can release safely, confidently, and on time.

Scaling

Scaling Without Compromising Safety
We help you implement scalable safety processes, strengthen governance structures, review workflows, and ensure your product remains clinically safe as features and user numbers grow.

Regulatory Compliance

Meeting Clinical & Compliance Standards
We support you with DCB0129, DCB0160, NHS DTAC, ISO 14971 alignment, ongoing governance, and audit preparation—reducing friction while keeping you compliant.

Clinical Governance Design

Building the Right Safety Structures
We assess your current governance, define roles and responsibilities, create reporting pathways, and design sustainable clinical governance frameworks tailored to your organisation.

Risk Management & Hazard Analysis

Understanding and Mitigating Clinical Risk
We identify clinical hazards, assess risk levels, produce and maintain hazard logs, and advise on mitigation strategies so your team can move fast—without creating avoidable harm.

Our services

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    Clinical AI Coding

    Providing highly skilled clinicians to accurately code your data, ensuring precision, compliance, and efficiency.

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    NHS DTAC, DCB0129/ DCB0160

    NHS regulatory compliance for the manufacturing and/or application in the deployment and use of Health IT Systems

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    Software/AI as a Medical Device

    Regulatory support with ISO and IEC standards and development of technical files

  • White mountain

    Clinical Safety and AI Consultancy

    System design, product and functionality support to ensure development of a clinically compliant and safe technology

Why us?

  • Blue mountain

    Bespoke Advice

    Advice personalised to your technology/device.

  • Snowy mountain

    Transparency

    No hidden fees or timelines.

  • House on a mountain

    Focus

    Focussed reviews of your product(s) to recognise errors and implement solutions.

  • Lake with mountains in the background

    Investment

    Protecting your investment by providing key frameworks and strategies for success.

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As trusted by

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Testimonials

Two people sitting having coffee

Providing a safe space to discuss regulation and compliance.

In person and remote meeting options are available.

All discussions are confidential, with an open arena to ask any questions be provided with support.

Book a Free Consultation
A pile of books

The Beginners Guide to Digital Clinical Safety

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Key questions when thinking about Digital Clinical Safety for your product

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Blog

Using ChatGPT in Healthcare Settings

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Artificial Intelligence and Pharmacy

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