Re:The Cancelled Comma One Would Have Embarrassed the Car In...
by EpicEng on Monday October 31, 2016 @08:52PM
(#12842473)
>Well, maybe the reason is that these regulator requests costs tons of money to fulfill because no, you cannot you give simple laymans answers to the questions, you need a team of lawyers to do this work, because everything you say in these "simple" requests can and will be used against you
No, what you need is to have followed a sufficient quality process to begin with. Lawyers aren't involved heavily in this sort of thing; your quality group is (well, it may take more lawyering for them at this point.)
This guy obviously didn't have a clue when he set out to build this thing and now his ignorance is biting him in the ass. I've worked on FDA regulated devices my entire career. You don't get to just throw things that represent a substantial safety risk onto the market without oversight, and that's a good thing.
No, what you need is to have followed a sufficient quality process to begin with. Lawyers aren't involved heavily in this sort of thing; your quality group is (well, it may take more lawyering for them at this point.)
This guy obviously didn't have a clue when he set out to build this thing and now his ignorance is biting him in the ass. I've worked on FDA regulated devices my entire career. You don't get to just throw things that represent a substantial safety risk onto the market without oversight, and that's a good thing.