AAMI Virtual Course – Process Validation Requirements & Industry Practices – April 8 – 10, 2026
This 3-day virtual 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 [...]
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 [...]