Introduction to this course: 

This course examines risk management for medical devices using the FMEA methodology to identify and evaluate potential failures in a medical device’s design and manufacturing and to determine the effects of these failures. This course covers hazard identification, risk evaluation, and effective mitigation strategies.

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 FMEA principles and techniques.

Learning Outcomes: 

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

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

• Explain the process of hazard identification and risk analysis in medical devices.

• Perform FMEA to evaluate and mitigate risks in medical devices.

What will I gain: 

Participants will gain a deeper understanding of FMEA principles and techniques, which will help them identify and mitigate potential failures, improve product quality, and reduce defects.

Prerequisites: 

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

Additional information: 

Course duration: 00:22:06

Course code/version (effective date): L-143/v1.0 (03/08/2023)