
Rebecca Wilson
Founder, CEO & Director of Clinical Safety

ISO 42001 is the international standard for AI management systems. It sets out how an organisation governs the development and use of AI responsibly.
In health and care, AI also needs clinical safety assurance under DCB0129 and DCB0160. We bring ISO 42001, clinical risk management and AI assurance together in one approach.
Any organisation that develops, provides or uses AI systems and wants a recognised way to govern them.
No. In health and care, AI still needs clinical risk management under DCB0129 and DCB0160. ISO 42001 sits alongside it.
Yes. ISO 42001 follows the same management system structure, so it fits well with an existing ISMS.
Book a free call with a DigiSafe expert. We'll scope the work, timelines and the right partnership, plain English, no jargon.
Multi-disciplinary lived experience across nursing, GP, paramedic, pharmacy, medical devices and data protection. Book a discovery call and we'll match you with the right expert.

Founder, CEO & Director of Clinical Safety

Chief Operating Officer

Medical Device and Compliance Expert

Medical Device and Compliance Expert

Clinical Safety Officer, Nurse

Clinical Safety Officer, GP

Clinical Safety Officer, Pharmacist

Clinical Safety Officer, Lead Trainer, Paramedic

Clinical Safety Officer, Occupational Therapist

Business Support Manager
Every engagement starts with a free 20-min scoping call, a conflict-of-interest check, and a plain-English summary before you commit.