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.
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
-

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

NHS DTAC, DCB0129/ DCB0160
NHS regulatory compliance for the manufacturing and/or application in the deployment and use of Health IT Systems
-

Software/AI as a Medical Device
Regulatory support with ISO and IEC standards and development of technical files
-

Clinical Safety and AI Consultancy
System design, product and functionality support to ensure development of a clinically compliant and safe technology
Why us?
-

Bespoke Advice
Advice personalised to your technology/device.
-

Transparency
No hidden fees or timelines.
-

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

Investment
Protecting your investment by providing key frameworks and strategies for success.
As trusted by
Testimonials
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.
