I am working on risk analysis.
I need clarification regarding the severity of a hazard.
Do we need to assign severity only considering that patient health is not affected....?
An example case is: App crash.
Although its not going to affect patient. From a company perspective, app crash is a severe issue to address when it happens during customer usage.
So in this case do I assign a severity as negligible or do I need to assign a severity as Major....?
Another thing is related to the aspects mentioned in IEC 60601-1, where it mentions compliance is checked in Risk Management File. Do we need to address all the points in Risk management file.
I need clarification regarding the severity of a hazard.
Do we need to assign severity only considering that patient health is not affected....?
An example case is: App crash.
Although its not going to affect patient. From a company perspective, app crash is a severe issue to address when it happens during customer usage.
So in this case do I assign a severity as negligible or do I need to assign a severity as Major....?
Another thing is related to the aspects mentioned in IEC 60601-1, where it mentions compliance is checked in Risk Management File. Do we need to address all the points in Risk management file.