FDA Submissions Using AI Tools: Ensuring Regulatory Success

Course Description

Formerly "Regulatory Submissions: Devices and Diagnostics."

This course is designed to provide individuals with pragmatic knowledge of how to craft medical device submissions for approval by the FDA using traditional and new AI tools. Students should already have a foundation in medical device terminology and regulations prior to taking this course. Through lectures, case studies, and hands-on exercises, new and experienced regulatory professionals learn how to work with the regulations, guidance documents, and AI tools to write portions of key medical device submissions that both comply with the requirements and are clear to the reviewers. Students explore the content and process of medical device submissions, as well as gain insight into timelines, important strategic considerations and business impacts.