I agree, and -- generally speaking -- OEMs take FDA compliance for Class III medical devices very seriously. If there is a regulation violation that could put

I agree, and -- generally speaking -- OEMs take FDA compliance for Class III medical devices very seriously. If there is a regulation violation that could put patients at risk, the FDA would not hesitate to shut down production and force a fix, whether it's hardware or software. (Speaking from the perspective of an IT guy at an electronics manufacturing company who is well versed in CFR 11 and medical validation.)