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Fault Tree Analysis (FTA) for Medical Technology Workshop

Fault Tree Analysis (FTA), sometimes known as event tree analysis, is a critical tool for identifying risks and ensuring the safety of medical devices, especially as artificial intelligence and machine learning (AI/ML) become increasingly integrated into healthcare. This expert-led session provides a structured approach to analyzing potential failures in MedTech systems and AI/ML-enabled devices, helping professionals enhance reliability and meet regulatory expectations.

Upcoming Courses

Quality Systems

Fault Tree Analysis (FTA) for Medical Technology Workshop (May 2025)

May 19 to May 19, 2025

Register

Overview

PROGRAM-AT-A-GLANCE

I. Introduction 

  • Welcome participants and introduction
  • Share the objectives of the training.
  • Gather participants input and interests
  • Briefly explain what FTA is and why it’s critical in MedTech and AI/ML.

II. Fundamentals of FTA 

  • Define key terms: events, gates, and logic.
  • Explain the steps to build a fault tree.
  • Walk through a simple example (e.g., a software device failure).
  • Knowledge Check

III.FTA for Medical Technologies

  • Discuss challenges in MedTech (e.g., complex systems, regulatory requirements).
  • Present a case study: FTA for a medical device (e.g., pacemaker or infusion pump).
  • Participant Q&A

IV.FTA for AI/ML-Enabled Devices 

  • Highlight unique risks in AI/ML (e.g., algorithmic bias, data dependency).
  • Present a case study: FTA for an AI/ML diagnostic tool.
  • Participant Q&A

V. Hands-On Exercise

  • Divide participants into small groups to complete group activity with handouts and templates.

VI. Best Practices and Tools (30 minutes)

  • Best practices (e.g., cross-functional teams, iterative updates).
  • Overview of FTA software tools (e.g., ReliaSoft, SAPHIRE).

VII.Q&A and Wrap-Up

  • Address questions and summarize key takeaways.
  • Recap the importance of FTA in MedTech and AI/ML.
  • Share resources for further learning (e.g., books, articles, software).

Objectives

Over the course of three (3) hours, the attendee/participant will be able to:

  • Understand the fundamentals of Fault Tree Analysis (FTA).
  • Learn how to apply FTA to medical technologies and AI/ML-enabled devices.
  • Gain hands-on experience building and analyzing fault trees.
  • Explore real-world case studies and best practices.

Who Should Attend?

This material will appeal to MedTech Engineers, QA professionals, managers, AI/ML developers, and regulatory affairs specialists. Instruction is targeted at professionals involved in risk analysis and management. Given the broad application of risk analysis, this material will be of value to professionals working across the entire product lifecycle.

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.