Clinical Safety & Regulatory Consulting
Digital Safety for Modern Healthcare Systems
Specialists in DCB0129, DCB0160, Clinical Safety Consulting, DTAC and Medical Device Regulation for healthcare organisations navigating digital transformation.
Trusted by leading healthcare organisations
Client organisations: , , , , , , , , ,
Our Expertise
Comprehensive clinical safety consulting
We provide end-to-end support for digital health organisations navigating complex regulatory requirements and clinical safety frameworks.
Clinical Safety Assurance
Expert guidance managing clinical risks for digital health systems.
DCB0129 Compliance
Full compliance support for manufacturers of health IT systems.
DCB0160 Clinical Risk
Safety frameworks for healthcare organisations deploying digital solutions.
Regulatory Consulting
Strategic guidance on digital health regulations and standards.
Why Choose Us
Proven expertise, trusted partnership
With decades of combined experience in healthcare, clinical safety, and regulatory affairs, we bring unmatched depth and insight to every project.
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20+ years healthcare experience
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Deep regulatory expertise
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Trusted by digital health leaders
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Proven safety frameworks
Testimonials
Trusted by industry leaders
"Tom provided excellent support to Prelego in preparing our DCB0129 clinical safety case and DTAC documentation. He combines deep regulatory knowledge with a very practical understanding of how digital health products are deployed within NHS environments. He was responsive, pragmatic, and helped us significantly strengthen our safety and compliance position ahead of deployment. I would strongly recommend him to other digital health companies navigating UK regulatory requirements."
Mikael Sodergren
Clinical Associate Professor, Imperial College London
"We recently worked with Tom on an end-to-end project, and the entire process has been a tremendous success. Tom took the time to thoroughly understand our application and its role within the digital clinical ecosystem. He provided clear explanations of the requirements and offered valuable advice that improved our product. The project was completed with exceptionally detailed documentation, which we are excited to share with our NHS customers."
Thomas Jordan
Operations Director, Mela Solutions Ltd
Ready to secure your digital health innovation?
Our team of experts is ready to guide you through regulatory requirements and build confidence in your digital health solutions.
Free Consultation