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  • jad73 replied to the topic Expense of Regulations in the forum Risk Analysis for Medical Devices 7 years ago

    I think that its only fair that getting a hold of these standards for regulations because these standards are what can possibly save a company from a lawsuit. However, sometimes regulatory standards are not enough measure to prevent injuries. I remember from one of my classes where the issues with the design on the Ford Pinto had caused the car to catch fire causing serious injuries and even death to users. There was a lawsuit filed against; However at that time, Ford’s defense was that the car design passed regulations and they were not held fully responsible for the accidents. There’s a whole lot of discussion regarding this but that’s for another topic (ethics) but this just shows how powerful regulatory standards are. It can save you or go against you in a lawsuit.