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This book is intended to provide an introduction to the application of a lifecycle approach to product design and development for medical devices. Medical Devic
Managing Medical Devices within a Regulatory Framework
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Public Health Effectiveness of the FDA 510(k) Clearance Process
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The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its asse
Trends in Development of Medical Devices
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Trends in Development of Medical Devices covers the basics of medical devices and their development, regulations and toxicological effects, risk assessment and
Medical Device Cybersecurity for Engineers and Manufacturers
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Cybersecurity for medical devices is no longer optional. We must not allow sensationalism or headlines to drive the discussion… Nevertheless, we must proceed