Education and TrainingMedical Devices

Global Medical Device Regulatory Strategy, Second Edition New Product Icon 

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Booth: 20

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.

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