AAMI Virtual Event – Integrating Risk Management to the Product Life Cycle – January 27 – 31, 2025 – 1:00 pm to 5:00 pm
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 – December 3 – 5, 2024
This intensive 3-day, 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 representatives during the entire course, [...]
AAMI Virtual Event – Medical Device Software Validation – October 22-24, 2024
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 [...]
Design Control Requirements – Integrating the Quality System Regulation – September 10 – 12, 2024
Overview 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 [...]