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Regulatory Focus™ > News Articles > Books: Medical Device Development: A Regulatory Overview

Books: Medical Device Development: A Regulatory Overview

Posted 01 April 2009 | By

Although this book is almost nine years old, it is still relevant regarding historical content and the derivations of various regulations. There are 15 chapters that cover topics ranging from the 510(k) regulations and requirements through the Premarket Approval requirements, designing clinical studies for devices, the reclassification process and working with FDA.

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