In most software, a red test is a bug. On the systems I work on, a red test can be a patient-safety signal. That one difference reshapes almost every decision you make when you sit down to design a quality strategy.I've spent more than a decade in software quality, most of it around medical device software: robotic-assisted surgery, surgical simulation, and clinical education platforms. The engineering is interesting on its own. What makes it genuinely hard is that every test, every pipeline, and every release has to satisfy two audiences at the same time. Engineers want fast feedback. Regulators want traceable evidence that the software does exactly what its requirements say, and nothing dangerous besides.