K
We are making a software application ,
we have following questions about the hardware and OS resposibilty as a manufacturer .
1) do we (Manufacturer) own the responsibility of Hardware and OS ? becasue as we dont have manufacured them (For example they are manufactured by windows or say HP).
2)Since the hardware and OS are closed-source and proprietary, how does the manufacturer determine and mitigate the risks?
3) What documentation needs to be submitted to FDA for the HW and OS risks?
Thanks in advance
we have following questions about the hardware and OS resposibilty as a manufacturer .
1) do we (Manufacturer) own the responsibility of Hardware and OS ? becasue as we dont have manufacured them (For example they are manufactured by windows or say HP).
2)Since the hardware and OS are closed-source and proprietary, how does the manufacturer determine and mitigate the risks?
3) What documentation needs to be submitted to FDA for the HW and OS risks?
Thanks in advance