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 [...]
AAMI Virtual Course: Design Control Requirements – Integrating the Quality System Regulation – July 16-18, 2024
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: Medical Device Software Validation – May 20-22, 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 [...]
AAMI Virtual Event: Process Validation Requirements & Industry Practices – April 9-11, 2024
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 [...]