Speaking from the perspective of healthcare software: ISO-13485 really isn't that heavy in the grand scheme of things. Once you establish your policies you can

Speaking from the perspective of healthcare software: ISO-13485 really isn't that heavy in the grand scheme of things. Once you establish your policies you can automate most of it with Jira, which can provide good traceability. It's really the testing requirements that are the most heavy, and whether you can do that in a few hours is 100% up to how good your testing setup is. I suspect that the quality management system is often this way at any mature tech company anyways, but who knows. When you need to perform a 510k, that's where the heaviness comes into play, even a special 510k can be considered heavy. For those uninitiated, here's the FDA guidance on when to perform a 510k: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-software-change-existing-device https://www.fda.gov/regulatory-information/search-fda-guidan... Rewriting a core piece of your software stack in a significantly different language is one such case (JavaScript to TypeScript? Probably not. Java to C++? Most certainly yes.).