IDEAL-D: a rational framework for evaluating and regulating the use of medical devices

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IDEAL-D: a rational framework for evaluating and regulating the use of medical devices

Sedrakyan, Art; Campbell, Bruce; Merino, Jose G; Kuntz, Richard; Hirst, Allison; McCulloch, Peter

BMJ (Online), 06/2016, Volume: 353

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High profile device failures have highlighted the inadequacies of current regulation. Art Sedrakyan and colleagues call for a move to a graduated model of approval and suggest a framework to achieve this goal

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