Integrating Risk Management into the Product Lifecycle and Quality Management System

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.


Training Details

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.

Hands-on activities with a medical device within the class will enhance the learning experience by:
  • Identifying hazards and hazardous situations through evaluation of a medical device design in normal and fault conditions.
  • Confirm harms using regulatory databases and international safety standards to design a safer device.
  • Consider the manufacturing processes to identify hazards that could be introduced into the medical device and how to prevent them.
  • Develop and challenge benefit-risk analysis of real-life situations during post-production.
 

Key Learning Objectives 

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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