Governing Intelligent
Medical Devices.
A nine-chapter book on AI regulation in medical devices — written for engineering teams, not lawyers.
Regulation as a design constraint, not an afterthought.
Most engineering teams encounter AI regulation in medical devices too late — after the architecture is set, after the model is trained, after the product roadmap has already assumed a compliance pathway that doesn't hold up. Governing Intelligent Medical Devices is written to close that gap.
Across nine chapters, the book covers the regulatory frameworks an engineering team building AI into a medical device needs to understand — FDA guidance, the EU Medical Device Regulation (MDR), and the EU AI Act — alongside practical risk management frameworks for teams working in regulated healthcare environments. The perspective throughout is the same one behind HeartVoice's ISO 13485 build-out and Omron Healthcare's Cyber Trust Mark certification: compliance is a design constraint the best teams work with, not around.
9 chapters
AI regulation in medical devices, written for engineering teams.
FDA guidance · EU MDR · EU AI Act
Risk management frameworks for regulated engineering teams
The manuscript is complete. It is not yet publicly available — reach out directly for details, review copies, or publishing inquiries.
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