Integrating Risk Management into the Product Lifecycle: Quality and 13485
November 7 - 9, 2018
This comprehensive 3-day course for medical device manufacturers presents 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. This course covers the use of risk management principles throughout the lifecycle of the product, from design…to manufacturing…through post-production to retirement. The course also shows linkages between the product risk management process and quality system processes. During the course, students 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 during risk management activities.