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.
Excellent refresher. Thank you!
This video is extremely helpful, more so than hours of poking around the internet. Thank you.
Glad to hear! @TonyNunn
Thank you.
What about software FMEA? I don't mean firmware but UI software running in a medical device. Any example?
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.
Thank you