AAMI Virtual Event – Medical Device Software Validation – May 20-22, 2025 – 8:00 am to 6:00 pm EST
Event Overview (Three 8-hour days from 9:00am-6:00pm EST) During this 3-day training, learn how to develop and validate medical device software in an ever-changing landscape of regulations and technology. This class will ground you in [...]
AAMI Virtual Course – Integrating Risk Management into the Product Life Cycle – May 6-8, 2025
This comprehensive 3-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA, ANSI/AAMI/ISO 14971:2019 and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course [...]
AAMI Virtual Course – Design Control Requirements – Integrating the Quality System Regulation – April 29 – May 1, 2025 – 9:00 am to 6:00 pm ET
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 – Process Validation Requirements and Industry Practices – April 8-10, 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 [...]