World Medical Device Standards Congress – April 13 – 14, 2026 in Leesburg, VA
The medical device/technology standards environment is a sprawling network of stakeholders whose shared goal is to write standards that advance patient safety and ultimately public health. International standards development organizations (SDOs) conduct their work with [...]
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 [...]