The intent of this book mddr for short is to present an introduction to and overview of the world of medical device regulation by the united states food and drug administration fda and the relationship of this regulatory scheme to the design and development of medical devices. Because design controls must apply to a wide variety of devices the regulation does not prescribe the practices that must be used instead it establishes a framework that. This guide is a starting point for research on design of medical devices and medical device regulation including resources for finding standards and materials. When it comes to design controls one of the most common problems i see medical device companies make is focusing on following the regulation rather than understanding its intent in other words they focus on what the words say and not what the regulation is trying to accomplish a literal
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