B
blazin912
Trying to understand how to interpret the FDA's concept of a "Software Device".
Our system is comprised of multiple software components running on multiple processors. This is a mix of unique software components and duplicates.
Processor 1:
OS with DSP
Processors 2-5:
4 Copies of RTOS w/ control loop (exact same source/sub system)
When considering a software failure of a software device, does this mean all software or a software component? ie Does a software failure mean the DSP goes whacky, while the control loops are ok? or All software is assumed to have gone haywire..?
I can't seem to grasp how it could be assumed that all software goes insane at the same time, but maybe I'm off base.
If there is a clear answer somewhere in the FDA guidance documents could a link be provided as well? Hot debate here! Thanks!
Our system is comprised of multiple software components running on multiple processors. This is a mix of unique software components and duplicates.
Processor 1:
OS with DSP
Processors 2-5:
4 Copies of RTOS w/ control loop (exact same source/sub system)
When considering a software failure of a software device, does this mean all software or a software component? ie Does a software failure mean the DSP goes whacky, while the control loops are ok? or All software is assumed to have gone haywire..?
I can't seem to grasp how it could be assumed that all software goes insane at the same time, but maybe I'm off base.
If there is a clear answer somewhere in the FDA guidance documents could a link be provided as well? Hot debate here! Thanks!
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