Key result
The IDEAL-D framework provides a graduated model of approval for evaluating and regulating medical devices to overcome the inadequacies of current regulatory systems.
Design
Editorial
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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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Proposes a graduated model of approval (IDEAL-D framework) to improve the regulation and evaluation of medical devices.
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Sedrakyan et al. (2016) studied this question. The IDEAL-D framework provides a graduated model of approval for evaluating and regulating medical devices to overcome the inadequacies of current regulatory systems.
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