||The U. S. Food and Drug Administration (FDA) audits the development of medical equipment. Their requirement for software testing seems to embrace or even require a BigDesignUpFront development model. Fortunately they have a companion document, an interpretation of the requirement, that was specifically written to make sure that they do not drive small and innovative manufacturers from the market. This document makes it clear that ExtremeProgramming style projects are not only acceptable, but even desireable. (But you still have to prepare for an audit.)
The FDA also requires that any automation must also meet FDA standards. This has lead some developers to avoid automation. We think that they would be much wiser to apply simple automation, like this framework, so that establishing compliance remains simple. Note: we do not assert such compliance here. That is your job.