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The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by america Meals and Drug Administration (FDA), and the connection of this regulatory scheme to the design and enchancment of medical devices. In providing this information, the book covers the broad differ of requirements, which might be launched inside eight principal topics: background and regulatory environment, device design administration, nonclinical testing, medical testing, promoting functions, publish-market requirements, high high quality methods/GMPs, and compliance/enforcement. This book provides school college students and professionals inside the medical device business with a road map to the regulation of medical devices. It presents a broad understanding of the breadth and depth of medical device regulation by amassing in a single textbook protection of the regulatory scheme for medical devices in phrases that are applicable for engineers, scientists, and healthcare suppliers. The large amount of data on the market on the subject is distilled proper right into a concise and coherent presentation.
There are additionally points and duties on the end of each chapter. Together with the usual questions requiring specific options, the duties embrace the drafting of a device administration plan, the occasion of a nonclinical examine course of, the resolution of a recall, the response to a Warning Letter, and the creation of a CAPA for a device deficiency. A choices information for these exercises is obtainable to teachers who undertake the textbook for classroom use. Medical Device Design and Regulation (MDDR) moreover makes obtainable over 100 complimentary reside hyperlinks to internet pages with additional associated information, and provides customers the prospect to hitch and participate inside the “MDDR Clients Group” on LinkedIn.
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