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The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements

This course is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturers, the FDA, industry consultants, and members of the International Organization for Standardization (ISO) standards development teams. Participants will learn how to develop and maintain a quality system program that conforms with the FDA’s Quality System Regulation (21 CFR 820) and ANSI/AAMI/ISO 13485:2016.

Learning outcomes/Benefits

  • Learn, in detail, the similarities and the differences between 21 CFR 820 and ISO 13485:2016.
  • Learn about FDA and Notified Bodies expectations during an inspection and industry best practices for implementing a quality management system.
  • Get an overview of the Medical Device Single Audit Program (MDSAP) and receive a free copy of the Quality System Compendium (a $600 value).
  • Access valuable reference documents, such as TIR102, and tools that can be immediately used in the application of a quality management system for medical devices.

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.

Testimonial

"I'm new to this field and found this course to be super helpful. The faculty were engaging, the course materials was applicable to all aspects of my job, and overall it was a wonderful experience. The faculty and staff were awesome!"


– Recent Course Attendee