M
mouse7
Hi all,
I work for a small medical device development firm, and we are designing an analog device to provide a medical treatment. We have been a bit stymied by IEC 62304.
The device output is controlled in an entirely analog manner. We are considering using a touchscreen GUI to initiate treatment, (essentially act as a switch), and report errors from the device (e.g. over temperature). The GUI would not have any control over treatment other than to start/ stop it.
In this scenario, does the software involved still classify as "Software that is a component and integral part of a medical device"? Is 62304 applicable?
Any insight you can provide is appreciated!
I work for a small medical device development firm, and we are designing an analog device to provide a medical treatment. We have been a bit stymied by IEC 62304.
The device output is controlled in an entirely analog manner. We are considering using a touchscreen GUI to initiate treatment, (essentially act as a switch), and report errors from the device (e.g. over temperature). The GUI would not have any control over treatment other than to start/ stop it.
In this scenario, does the software involved still classify as "Software that is a component and integral part of a medical device"? Is 62304 applicable?
Any insight you can provide is appreciated!