AAMI Virtual Event – Design Control Requirements – Integrating the Quality System Regulation – July 15-17, 2025 – 9 am to 6 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 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 [...]