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That's how it works in the FDA regulated medical device and medical software industry. We had a woman who could shut us down on a whim. (And she would, from tim
by bilbo0s 8y ago
That's how it works in the FDA regulated medical device and medical software industry. We had a woman who could shut us down on a whim. (And she would, from time to time.)
That said, in the FDA regulated industry, every change was signed by not only the engineer, but by the QA person, by the engineering manager, and by her. So in fairness to her, SHE would have been one of the people going to jail if the software told a doctor to take out the wrong kidney because of a bug in the calculation of an ortho normal basis or something. So I didn't blame her one bit.