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The Changing AI/ML Medical Device Regulatory Landscape

This training will describe current and upcoming regulatory trends in AI-enabled medical devices such as software as a medical device (SaMD).  This training will similarities and differences in regulations across jurisdictions such as the USA FDA, EU, UK, ASEAN region, Australia, and Canada.  It will cover impacts to manufacturers’ device design, labeling, QMS and cybersecurity processes.

Upcoming Courses

Quality Systems

The Changing AI/ML Medical Device Regulatory Landscape (October 2025)

Oct 9 to Oct 9, 2025

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Overview

  1. AI Regulations Overview. We will the various types of regulations, guidance and standards that apply to AI. This includes medical and non-medical AI.
  2. Current Regulatory Landscape. Discuss where globally there are AI regulations, focusing on medical device AI regulations.
  3. AI Design. We will cover where and what requirements there are for AI design, development, testing & bias. We will highlight any jurisdictional differences.
  4. AI Labeling. We will cover where and what requirements there are for AI labeling, transparency, and ethics. We will highlight any jurisdictional differences.
  5. Cybersecurity, Privacy, & Data Ownership. We will cover any specific requirements regarding AI medical devices vs. software as a medical device in general.
  6. Regulatory Landscape & References. Discuss where attendees can find the latest & upcoming regulatory requirements before they are released. Give additional examples of things that are being discussed such as 3rd party AI accuracy test labs.

Objectives

Over the course of two (2) hours, the attendee/participant will be able to:

  • Develop a regulatory strategy for a new design project including what AI training, testing and labeling considerations should be in place.
  • Apply regulatory requirements and considerations in their QMS
  • Understand where to find the latest regulatory trend information.

Who Should Attend?

Medical Device Manufacturers especially the Quality, Regulatory, AI/ML Engineering, Clinical and Security departments

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.