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Integrating Risk Management into the Product Lifecycle

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, ANSI/AAMI/ISO 14971 and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course covers the use of risk management principles throughout the life cycle of the product, from design…to manufacturing…through post-production to retirement. Instructors will illustrate linkages between the product risk management process and quality system processes. Students will discover how to use regulatory databases to support risk management activities at different stages of the product life cycle, as well as the use of International Product Safety Standards during risk management activities.

Program Objective 

FDA and AAMI faculty work together to help the learner understand: 

  • Basic terms of risk management and how they relate to each other and how to use risk management throughout the quality system to make risk-based decisions for product realization cradle to grave.
  • How to use a variety of risk management tools to support risk-based thinking and decision making along with typical scenarios when the tools can be most useful.
  • FDA's expectations for submissions and compliance, as well as how to apply risk management principles to various aspects of a quality system as required by the FDA and ISO 13485:2016, 
  • The current state of risk management based on ISO 14971 and other applicable product safety standards including those related to processes and those related to specific medical device products. 
  • How risk management is audited during MDSAP audits and how that relates to country specific requirements for risk management activities or risk-based decisions. 


Virtual Training Information

Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.

For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email education@aami.org.


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