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). 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 

Join Martin King and Dipo Ajose-Coker as they unpack the current trends technical documentation and show how structured content transforms compliance into competitive advantage.

Can't make it live? No worries! Simply sign up, and we'll share the recording with you afterward. We do encourage you to join us live to interact with our experts and ask any questions you may have. Once you have registered, you will receive an email from GoToWebinar, our webinar hosting provider, with details of how you can join the webinar.