The future of medical device regulation : innovation and protection

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Tác giả: I. Glenn Cohen, Timo Minssen, W. Nicholson Price, Christopher T Robertson, Carmel Shachar

Ngôn ngữ: eng

ISBN: 9781108975452 (ebook)

Ký hiệu phân loại: 344.041 *Medical personnel and their activities

Thông tin xuất bản: Cambridge : Cambridge University Press, 2022.

Mô tả vật lý: 1 online resource (xiv, 280 pages) : , digital, PDF file(s).

Bộ sưu tập: Tài liệu truy cập mở

ID: 313174

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.
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