Monthly Archives: September 2025

This intensive 3 – day course provides complete coverage of design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during the entire course, attendees have the unique opportunity to participate in a shared learning experience. For more information:  https://aami.org/event/design-control-requirements-integrating-the-qmsr-dublin-ire-oct-2025/

Event Overview (Three 8-hour days from 9:00am-6:00pm EST) Join us a develop a comprehensive understanding of risk management concepts used throughout the quality management system to consistently meet FDA 21 CFR 820 regulations and ISO 13485 requirements utilizing ISO 14971 and ISO 24971. Attendees will learn how to use risk management files and risk analysis [...]