“A Methodology for Safety Case Development” was the result of a research grant. It discusses development of safety cases. Essentially development of justification for the safety of software in a given system/use.
While FDA requires risk and software hazard analysis there is significant value, in our opinion (SoftwareCPR), in constructing rationale that demonstrates safety rather then strictly performing and documenting hazard analyses. This paper provides some theoretical background for doing so. It is not copyrighted and can be distributed.