Clinical Evaluation of Medical Devices : Principles and Case Studies
From Book News, Inc. Covers the key principles and approaches used in medical device clinical trials, and demonstrates the implementation of these principles in a series of detailed case studies. Building on the techniques used in the clinical trials of pharmaceuticals, contributors show how to design and evaluate the clinical trials of medical devices, as well as how best to collect data that is acceptable to the FDA. Also covers why and how clinical research fits into the development and marketing of new product concepts, and spells out international regulatory requirements for research and registration of medical devices. Book News, Inc.®, Portland, OR
Synopsis This text serves as a technical resource for scientific and regulatory professionals working in the field of new medical device development and commercializaiton. Chapters cover the basic principles of clinical study design and analysis, (including protocol requirements, selecting suitable endpoints, selecting a control group, sample size calculations, monitoring, data analysis and presentation); and those describing research approaches on different classes of devices such as implanted devices...
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