Benefit from the expertise and rigor of AAMI faculty as you learn today’s best practices for conducting internal audits and supplier audits for regulatory compliance.

Learn to Identify when a 510(k) submission is required by the U.S. Food and Drug Administration, what medical devices are exempt from review, the various 510(k) submission types, and the processes for submitting 510(k) applications.

This course provides a basic introduction to regulatory writing for medical devices. Participants will learn how to write documents which will be able to meet internal and external stakeholder expectations. Through lectures, discussions and hand-on exercises, participants will learn the best practices for regulatory writing.