indubioush
Ah ha!
Hello. Hoping I can get some help here. I currently work for an IVD company that has firmware, software, hardware, and a consumable in its device system. My question is whether I should do a software-only FMEA or if software associated risks can just be incorporated into another FMEA. I previously worked for an implantable device company, and there we did a design fmea, use fmea, and process fmea. Then I am used to a hazard analysis document that ties them all together. What is the norm for a device with software?
Thanks!
Thanks!