S
sl344
Hello,
We have this piece of firmware that is embedded inside the medical device. the device itself is classified as class III. Based on the software hazard analysis, this firmware could potentially cause minor pain (and/or bruising) on patient skin. Based on IEC 62304, class A software has to be 'no injury or damage to health is possible'. Given that, what class do you think this firmware should be? is minor pain(bruising) considered an injury??
thanks a lot!
We have this piece of firmware that is embedded inside the medical device. the device itself is classified as class III. Based on the software hazard analysis, this firmware could potentially cause minor pain (and/or bruising) on patient skin. Based on IEC 62304, class A software has to be 'no injury or damage to health is possible'. Given that, what class do you think this firmware should be? is minor pain(bruising) considered an injury??
thanks a lot!