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by Benjamin Walker, James Smith, Peter Takes, Prithal Bom, Gert Bos, David Brindley, Joanna Brougher, Andrew Carr, Stanely Chalvire, Tony Chan, Xianjun Chen, Mark Chipperfeld, Raymond Chua, Stewart Crumpler, Benjamin Davies
As globalization continues to increase, more companies are marketing products in multiple countries and regions. This book provides a "how to" guide to developing a comprehensive global regulatory strategy for all types of medical devices. Discussions cover medical device types, assembling a core development from multiple departments to create a strong, viable strategy to market a product in more than one jurisdiction, and basic strategy components. There also is information on device design and development elements, setting up a quality management system, labeling strategies and manufacturing. Other chapters look at the Notified Body's viewpoint on regulatory strategy and that of regulators. Much more information is included in the book, including the use of standards cover global regulatory processes and how patents apply to medical devices.
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