Our CPD-certified regulatory and clinical safety training for digital health teams is practical and hands-on. We support people to build skills that stick and close the gap between theory and real-world application.
Includes CSO practitioner, innovation & research regulatory pathways, DCB0129/0160 compliance, EU MDR, ISO standards, and AI governance and risk management.
Access experienced Clinical Safety Officers (CSOs) on demand. Ideal for organisations lacking internal CSO capacity or needing extra support.
Our practitioners provide credible, practical leadership to safeguard patient safety and ensure compliance.
The UK’s only structured Clinical Safety Officer mentoring programme.
Build confidence and capability with ongoing guidance, helping clinicians and digital leaders step into safety roles effectively.
End-to-end support for organisations developing or deploying medical devices and regulated software.
Navigate UKCA, CE, and international regulation, ensuring compliance that protects patients and stands up to scrutiny.
We implement and assure ISO standards that strengthen governance, quality, and organisational capability.
Includes ISO 13485, ISO 27001, and ISO 42001.
We help organisations adopt AI safely through practical governance, assurance, impact assessment, supplier review, and monitoring — all supporting ISO standards.
We also run healthcare-specific AI governance and risk management training covering emerging standards and implementation frameworks.
Dean Mawson
Founder and Clinical Director.
Brett Marshall
Regulatory Affairs Lead.
Catherine Corbett
Clinical Safety Officer.
The healthtech regulatory landscape is changing fast.
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