AAMI Course – Design Control Requirements – Integrating the QMSR – October 6 – 9, 2025 – Dublin, Ireland
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 [...]
AAMI Virtual Course – Integrating Risk Management into the Product Life Cycle – October 1 – 3, 2025 – 9 am to 6 pm ET
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 [...]
AAMI Virtual Event: The Quality Management System Regulation – August 18-22, 2025
This 4.5 day course is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturers, the FDA, industry consultants, and members of International [...]
AAMI Virtual Course – Process Validation Requirements and Industry Practices – August 5 -7, 2025
This 3-day course provides attendees with practical tools and techniques for process validation requirements for FDA’s Quality System Regulation and recognized process validation guidance from the Global Harmonization Task Force. The program includes industry best [...]