It is interesting to carefully read the FDA requirements for software and medical devices. The FDA requirement is for the safety of all people connected with the use of the device, from the intern moving the thing around to the doctor using it to the patient most concerned with its effects. All “bad” outcomes must be either eliminated or mitigated. But interestingly there is no requirement that the device work!
Perhaps it is presumed that non-working devices will not get out on the market. But there will always be “snake oil” salespeople and those that just don’t realize what is going on. Self-policing versus greed and ambition. And the latter two are huge in the medical industry.
QA must ensure that the FDA requirements are met. But it needs to go further. It needs to push back on deadlines and quick fixes and promises that “we’ll fix it before it goes out the door.” QA needs to be the consumer advocate and ensure the efficacy of everything before the FDA approves of the product. Once FDA approved, changes to a product, no matter how well intentioned or required, void that approval. And without approval there can be no selling of the product in the US.
In short, quality must be built in, not added on. It is the role of QA to participate early and often in the product life cycle and ensure that this is understood by all participants. Failure to do so can not only cost lives, it can ultimately kill your company.