AAMI Virtual Event: Design Control Requirements – Integrating the Quality System Regulation – February 12-14, 2024
This intensive 3-day, hybrid (in-person or virtual) 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 [...]
AAMI Event – Medical Device Software Validation – November 7-9, 2023
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 all the relevant regulations, standards and guidance and [...]
AAMI Virtual Event: Integrating Risk Management into the Product Life Cycle – October 3-5, 2023
This course will cover risk management principles used throughout the lifecycle of a product (design, manufacturing, post-production, and retirement). Instructors will also identify linkages between risk management processes and quality system processes. Participants will discover [...]
AAMI Virtual Event – Design Control Requirements – Integrating the Quality System Regulation – September 12-14, 2023
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 [...]