AI in MedTech: Building AI‑ready technical files with structured content
On-Demand Webinar
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. 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). This enables both human reviewers and AI systems to follow a clear, verifiable narrative across submissions.
You’ll Learn:
- What structured content is, and how it helps regulatory affairs in their daily tasks.
- How a CCMS supports technical files, submissions, and audit readiness.
- Why separating content from formatting unlocks reuse across SOPs, IFUs, and policies.
- How a single source of truth improves traceability, version control, and translation workflows.
- How governed AI practices align with NIST AI RMF and ISO/IEC 42001 Information technology, Artificial intelligence, Management system