> Maybe we worked in different fields? Class III devices (pacemakers, deep brain stimulators, insulin pumps) > Did the FDA actually check your software or jus

> Maybe we worked in different fields? Class III devices (pacemakers, deep brain stimulators, insulin pumps) > Did the FDA actually check your software or just your documentation? In a submission, occasionally. In an audit, it depended on the nature of an audit. I've been part of one audit that was due to persistent SW failure and yes, they checked code. > Did you find the process of writing documentation instrumental in ensuring that your software was carefully tested? No, but that's not really the point of documentation. > Did you ensure that your tests were reproducible and comprehensive? Yes, we could kill people if we screwed something up. > They were more concerned with making sure signatures and dates were correct and that our documentation didn't make us look bad. This practice is common, I grant. Doesn't mean it's universal or right. > The FDA doesn't really give a damn about what I really worked on, do they? FDA heavily triages activity based on risk. If your product is life-sustaining they will definitely be all up in your business.