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Hello,
how i can classify according to the IEC 62304, a software that manages information supporting the diagnosis?
A software failure can mislead the doctor's judgment and lead to misdiagnosis. The medical device is not intended to diagnose, but to help the physician to determine who is mostly definitely healthy, so as to avoid unnecessary additional examinations.
I might classify it belonging to class b, because a software failure does not have a direct impact on patient health, as might be the software that controls an arm surgical, but indirectly as a result of its use by an inexperienced doctor, who may leave affect oneself by the medical device.
What do you think?
how i can classify according to the IEC 62304, a software that manages information supporting the diagnosis?
A software failure can mislead the doctor's judgment and lead to misdiagnosis. The medical device is not intended to diagnose, but to help the physician to determine who is mostly definitely healthy, so as to avoid unnecessary additional examinations.
I might classify it belonging to class b, because a software failure does not have a direct impact on patient health, as might be the software that controls an arm surgical, but indirectly as a result of its use by an inexperienced doctor, who may leave affect oneself by the medical device.
What do you think?