Articoli correlati a The Future of Medical Device Regulation: Innovation...
Sinossi
A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.
Le informazioni nella sezione "Riassunto" possono far riferimento a edizioni diverse di questo titolo.
Informazioni sugli autori
I. Glenn Cohen is James A. Attwood and Leslie Williams Professor of Law, Deputy Dean, and Faculty Director in the Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics, Harvard Law School.
Timo Minssen is Professor of Law is Director of the Center for Advanced Studies in Biomedical Innovation Law (CeBIL) in the Faculty of Law, University of Copenhagen, Denmark.
W. Nicholson Price II is Professor of Law in the University of Michigan School of Law.
Christopher Robertson is Professor and N. Neal Pike Scholar of Health and Disability Law in the School of Law, Boston University.
Carmel Shachar is Executive Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.
Le informazioni nella sezione "Su questo libro" possono far riferimento a edizioni diverse di questo titolo.
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The Future of Medical Device Regulation
Editore:
Cambridge University Press, New York, NY, 2022
ISBN 10: 1108972055
ISBN 13: 9781108972055
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Da: Rainy Day Paperback, Bethel, CT, U.S.A.
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trade paperback. Condizione: Near Fine. Like new, appears unread. 280 pages, 9" x 6'' - Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices. Offers a unique focus on the regulatory affairs industry, specifically targeted at regulatory affairs professionals and those seeking certification Puts regulations in the context of contemporary design Includes case studies and applications of regulations.--- 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. Codice articolo C4-H18
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The Future of Medical Device Regulation
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Cambridge University Press, 2022
ISBN 10: 1108972055
ISBN 13: 9781108972055
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Da: Books for Life, LAUREL, MD, U.S.A.
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Condizione: very_good. Book is in very good condition. Clean with little to no signs of wear or markings highlights. Codice articolo LFM.9FLW
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The Future of Medical Device Regulation
Editore:
Cambridge University Press, 2022
ISBN 10: 1108972055
ISBN 13: 9781108972055
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paperback. Condizione: Very Good. Codice articolo mon0003805806
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The Future of Medical Device Regulation: Innovation and Protection
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Cambridge University Press, 2022
ISBN 10: 1108972055
ISBN 13: 9781108972055
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Condizione: Good. This is an ex-library book and may have the usual library/used-book markings inside.This book has soft covers. In good all round condition. Please note the Image in this listing is a stock photo and may not match the covers of the actual item,550grams, ISBN:9781108972055. Codice articolo 2381125
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The Future of Medical Device Regulation
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Condizione: New. Codice articolo I-9781108972055
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The Future of Medical Device Regulation
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Cambridge University Press, GB, 2022
ISBN 10: 1108972055
ISBN 13: 9781108972055
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Paperback. Condizione: New. 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. Codice articolo LU-9781108972055
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The Future of Medical Device Regulation: Innovation and Protection
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Cambridge University Press 2022-04-07, 2022
ISBN 10: 1108972055
ISBN 13: 9781108972055
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Paperback. Condizione: New. Codice articolo 6666-IUK-9781108972055
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The Future of Medical Device Regulation: Innovation and Protection
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Cambridge University Press, 2022
ISBN 10: 1108972055
ISBN 13: 9781108972055
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Paperback / softback. Condizione: New. This item is printed on demand. New copy - Usually dispatched within 5-9 working days. Codice articolo C9781108972055
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The Future of Medical Device Regulation
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Condizione: New. In English. Codice articolo ria9781108972055_new
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The Future of Medical Device Regulation
Da: Books Puddle, Woodside, NY, U.S.A.
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Condizione: New. New edition NO-PA16APR2015-KAP. Codice articolo 26390148430
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