Global Medical Device Regulatory Strategy, Second Edition

The second edition of Global Medical Device Regulatory Strategy includes timely updates on all chapters, current information on cybersecurity and software, new international regulations and a new chapter on driving successful commercial product launches. This book provides a how-to guide to developing a comprehensive global regulatory strategy for all types of medical devices, including discussions on the development and implementation of global regulatory strategies for medical devices, labeling, clinical, risk management, marketing and postmarketing. The use of standards and regulatory resources for strategy development is discussed as well as need for developing a comprehensive global regulatory process. Other topics include regulation of therapies, devices, combination products and in vitro diagnostic medical devices.

Who Should Read This Book

This book is intended for both the experienced regulatory professional and those entering the profession and designing their own pathway to success in this vastly enriching field. It can be used as a contemporary and integral bookshelf reference in Regulatory Affairs departments of all sizes, as well as a routine textbook in expanding academic curricula in regulatory affairs and quality systems.

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Published by RAPS © 2020. Hardcover. 412 pages. ISBN: 978-1-947493-53-7.