Event Overview
(Three 8-hour days from 9:00am-6:00pm EST)
Join us a develop a comprehensive understanding of risk management concepts used throughout the quality management system to consistently meet FDA 21 CFR 820 regulations and ISO 13485 requirements utilizing ISO 14971 and ISO 24971. Attendees will learn how to use risk management files and risk analysis concepts to make risk-based decisions for medical device product realization and other quality management system process decisions throughout a device’s lifecycle.
Benefit from the insight of AAMI Faculty and FDA representatives as you learn detailed risk management concepts used throughout the quality system that can help your organization meet FDA and ANSI/AAMI/ISO 13485:2016 requirements for risk management using ANSI/AAMI/ISO 14971:2019 and ANSI/AAMI/ISO TIR24971:2020.
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 how to use regulatory databases to support risk management activities at different stages of the product lifecycle, as well as the use of International Product Safety Standards.
For more information: https://aami.my.site.com/s/lt-event?id=a1YUW00000FIUTd