Well, I've spent the last decade designing FDA cleared systems (class I and class III), and I can tell you that it is. That doesn't mean that mistakes aren't ma

Well, I've spent the last decade designing FDA cleared systems (class I and class III), and I can tell you that it is. That doesn't mean that mistakes aren't made, and it doesn't mean that you can't outright lie in documentation. There's no way the FDA could catch that short of replicating all of your V&V. However, most of us aren't trying to cheat, and I can tell you that the amount of engineering rigor that goes into a medical device is leagues beyond what most software devs have ever been a part of. At my company we don't hire "developers"; we hire engineers who have programming in their toolbox. Medical software screwups are high profile. You don't hear about every bug that the next "disruptive startup" lets into the wild.