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Quality Systems Foundation

Comprising 8-hours spread out over two days, Foundation Courses combine instructor-led training and hands-on exercises to quickly orient participants to the subject matter covered. Foundation Courses attendees to strike the perfect balance between practical, hands-on training and broader career development!

Upcoming Courses

Quality Systems

Quality Systems Foundation (Jan25)

Jan 13 to Jan 14, 2025

Register

Overview

Are you curious about the upcoming FDA Quality Management System Regulation (QMSR)?

Would you like to enhance your understanding of the intent of requirements, build confidence throughout your organization and improve quality? 

Developed by medical device industry experts, this course provides an engaging and informative overview of the FDA requirements including ISO 13485:2016, which will be incorporated by reference into the QMSR.

Objectives

Whether you are new to medical devices, have been in the industry for a few years, or are an industry veteran looking for a refresher course, you will leave this course with the confidence to address problematic QMS challenges, such as:

  • What are the requirements for risk management, and how is risk integrated throughout the QMS?
  • What is the difference between design verification, design validation, process validation, and software validation?
  • What is a statistical rationale?
  • What are top management’s responsibilities for the development and implementation of the QMS?
  • How does a manufacturer ensure the continued suitability, adequacy, and effectiveness of their quality management system?

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.