AI in MedTech: Building AI‑ready technical files with structured content

AI is no longer a distant frontier; it’s reshaping how regulators evaluate medical devices. With structured submission templates like FDA eSTAR, international models such as IMDRF’s Table of Contents, and the EU AI Act’s phased obligations for high-risk AI-enabled devices, the shift to digital is accelerating.. . In this first episode, Martin King and Dipo Ajose-Coker unpack the foundational shift toward structured based content as the key to building AI-ready submissions.