The industry changes slowly, and definitely regulators like the FDA were too hardware focused for a long time. Less so in the last 10-20 years. They've always

The industry changes slowly, and definitely regulators like the FDA were too hardware focused for a long time. Less so in the last 10-20 years. They've always been pretty good about critical systems but less so about "secondary" ones, and there are old devices out there where it shows. These days most of the industry has reasonable guidance and standards to follow. Characterizing "the industry" is hard; it includes cloud based data handling products and embedded devices with minimal software, etc. - a huge range. In both these areas (and others,to be sure), there is a formal engineering process that looks quite similar - and you need to embrace it in your software development or there will be a lot of friction. The goals of it are pretty sensible, but the approaches may seem odd to some with more mainstream software backgrounds.