Do you have to do a hazard analysis for new features you add to the non-device functions of the software medical device? The Multiple Function Guidance would say only an impact analysis, but I know some developers would say nothing at all.
The software hazard analysis needs to be updated whenever you make a change to the SRS or the SDS. An impact analysis is intended to identify how much revalidation is required for the change, and IEC/TR 80002-1 was created to help developers understand that a software hazard analysis needs to include more than just hazards that directly cause harm. The software hazard analysis needs to include hazardous situations too.
