



Since I’m writing a blog, and not a comprehensive textbook, I’m taking the low road. It’s opinion, hyperbole, arm-waving, and humorous examples, all the way. You won’t find (m)any rigorously applied scholarly citations, research data, or perfectly crafted statements of absolutes. The material is merely intended to be helpful to you if you’re trying to figure out how to structure your organization and processes to invent, prove, and maintain medical devices that exhibit the characteristics of complex systems.










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