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 tools like FDA eSTAR, IMDRF’s Table of Contents, and the EU AI Act driving digital transformation, the question is only how fast sponsors need to adopt AI. . In this first episode, we unpack the foundational shift toward structured based content as the key to building AI-ready submissions. Instead of burying claims and evidence in static PDFs and Word documents, structured content allows every element to be stored as reusable, traceable components within a Component Content Management System (CCMS).