The Future of Medical Device Regulation

Innovation and Protection

I Glenn Cohen editor Carmel Shachar editor Christopher Robertson editor Timo Minssen editor W Nicholson Price II editor

Format:Paperback

Publisher:Cambridge University Press

Published:7th Apr '22

Currently unavailable, and unfortunately no date known when it will be back

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The Future of Medical Device Regulation cover

A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.

As the nature of medical devices is rapidly changing, the legal and ethical questions around medical devices are becoming ever more complex. This volume analyses the current issues and controversies around patient privacy, innovation, and new regulatory laws in the US and EU.Regulators have been more permissive for medical devices compared to their drug and biologic counterparts. While innovative products can thereby reach consumers more quickly, this approach raises serious public health and safety concerns. Additionally, the nature of medical devices is rapidly changing, as software has become as important as hardware. Regulation must keep pace with the current developments and controversies of this technology. This volume provides a multidisciplinary evaluation of the ethical, legal, and regulatory concerns surrounding medical devices in the US and EU. For medical providers, policymakers, and other stakeholders, the book offers a framework for the opportunities and challenges on the horizon for medical device regulation. Readers will gain a nuanced overview of the latest developments in patient privacy and safety, innovation, and new regulatory laws. This book is also available as Open Access on Cambridge Core.

ISBN: 9781108972055

Dimensions: 228mm x 152mm x 16mm

Weight: 439g

350 pages