FMEA vs ISO 14971

This is an excerpt from the course "Introduction to Risk Management for Medical Devices and ISO 14971:2019" which is available at:
medicaldevicehq.com/iso14971
Read more about how to work with medical device risk management here:
medicaldevicehq.com/articles/...
Chapters:
00:00 Introduction
00:25 What this video will cover
01:17 What does FMEA stand for?
02:00 The advantages of using standard terms and concepts
02:54 What is FMEA according to the standard?
04:54 FMEA vs ISO 14971 risk management
09:02 Should you use FMEA?
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[@munasofi5037]

Thank you

[@pauloquicoli]

What about software FMEA? I don't mean firmware but UI software running in a medical device. Any example?

[@MedicalDeviceHQ]

The information in the video is applicable regardless of what area you conduct the FMEA on. For a user interface, you can identify the risk by using a process based on ISO 14971, or you can identify the risks using FMEA AND ISO 14971 risk analysis. Remember, that ISO 14971 requires, among other things, that you include "combination of events", which would not be done if you only approach it using FMEA.