Introduction to this course: 

This course examines risk management for medical devices using the FTA methodology to determine the probability of an unwanted event in medical devices, identify the root causes of system failure through the use of a diagram, and mitigate risk before it occurs using a top-down approach with FTA diagrams and Boolean logic.

Who should attend: 

This course is designed for professionals involved in the design, maintenance, marketing, manufacturing, service, or risk management teams who want to gain a deeper understanding of FTA methodology.

Learning Outcomes: 

By the end of this lesson, you will be able to:

• Identify key concepts of ISO 14971:2019 and FTA.

• Explain the differences between FMEA and FTA in risk analysis.

• Construct fault tree diagrams for medical devices.

What will I gain: 

Participants will gain a deeper understanding of FTA methodology to predict and prevent device failures, improving overall device safety and regulatory compliance.

Prerequisites: 

It is recommended that participants have a basic understanding of risk management and ISO 14791:2019. A basic understanding of medical device development and quality management systems would be beneficial.

Additional information: 

Course duration: 00:21:27

Course code/version (effective date): L-144/v1.0 (18/09/2023)