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 [...]
AAMI Event – Process Validation Requirements & Industry Practices – August 7-9, 2023
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 [...]