Items related to The Future of Medical Device Regulation
Synopsis
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.
"synopsis" may belong to another edition of this title.
About the Authors
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.
"About this title" may belong to another edition of this title.
Search results for The Future of Medical Device Regulation
Seller Image
The Future of Medical Device Regulation
Published by
Cambridge University Press, New York, NY, 2022
ISBN 10: 1108972055
ISBN 13: 9781108972055
Used
trade paperback
Seller: Rainy Day Paperback, Bethel, CT, U.S.A.
Seller rating 4 out of 5 stars
trade paperback. Condition: 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. Seller Inventory # C4-H18
Seller Image
The Future of Medical Device Regulation
Published by
Cambridge University Press, 2022
ISBN 10: 1108972055
ISBN 13: 9781108972055
Used
Softcover
Seller: Books for Life, LAUREL, MD, U.S.A.
Seller rating 5 out of 5 stars
Condition: very_good. Book is in very good condition. Clean with little to no signs of wear or markings highlights. Seller Inventory # LFM.9FLW
Stock Image
The Future of Medical Device Regulation
Published by
Cambridge University Press, 2022
ISBN 10: 1108972055
ISBN 13: 9781108972055
Used
paperback
Seller: Books From California, Simi Valley, CA, U.S.A.
Seller rating 4 out of 5 stars
paperback. Condition: Very Good. Seller Inventory # mon0003805806
Stock Image
The Future of Medical Device Regulation
Published by
Cambridge University Press, 2022
ISBN 10: 1108972055
ISBN 13: 9781108972055
New
Softcover
Seller: California Books, Miami, FL, U.S.A.
Seller rating 5 out of 5 stars
Condition: New. Seller Inventory # I-9781108972055
Seller Image
The Future of Medical Device Regulation
Published by
Cambridge University Press, GB, 2022
ISBN 10: 1108972055
ISBN 13: 9781108972055
New
Paperback
Seller: Rarewaves.com USA, London, LONDO, United Kingdom
Seller rating 5 out of 5 stars
Paperback. Condition: 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. Seller Inventory # LU-9781108972055
Buy New
US$ 66.85
Free Shipping
Ships from United Kingdom to U.S.A.
Ships from United Kingdom to U.S.A.
Quantity: Over 20 available
Stock Image
The Future of Medical Device Regulation
Published by
Cambridge University Press, 2022
ISBN 10: 1108972055
ISBN 13: 9781108972055
New
Softcover
Seller: Ria Christie Collections, Uxbridge, United Kingdom
Seller rating 5 out of 5 stars
Condition: New. In. Seller Inventory # ria9781108972055_new
Buy New
US$ 63.61
US$ 16.19 shipping
Ships from United Kingdom to U.S.A.
Ships from United Kingdom to U.S.A.
Quantity: Over 20 available
Stock Image
The Future of Medical Device Regulation: Innovation and Protection
Published by
Cambridge University Press 2022-04-07, 2022
ISBN 10: 1108972055
ISBN 13: 9781108972055
New
Paperback
Seller: Chiron Media, Wallingford, United Kingdom
Seller rating 5 out of 5 stars
Paperback. Condition: New. Seller Inventory # 6666-IUK-9781108972055
Buy New
US$ 59.11
US$ 20.94 shipping
Ships from United Kingdom to U.S.A.
Ships from United Kingdom to U.S.A.
Quantity: Over 20 available
Stock Image
The Future of Medical Device Regulation
Published by
Cambridge University Press, 2022
ISBN 10: 1108972055
ISBN 13: 9781108972055
New
Softcover
Seller: Books Puddle, New York, NY, U.S.A.
Seller rating 4 out of 5 stars
Condition: New. New edition NO-PA16APR2015-KAP. Seller Inventory # 26390148430
Stock Image
The Future of Medical Device Regulation: Innovation and Protection
Published by
Cambridge University Press, 2022
ISBN 10: 1108972055
ISBN 13: 9781108972055
New
Paperback / softback
Seller: THE SAINT BOOKSTORE, Southport, United Kingdom
Seller rating 5 out of 5 stars
Paperback / softback. Condition: New. This item is printed on demand. New copy - Usually dispatched within 5-9 working days. Seller Inventory # C9781108972055
Buy New
US$ 72.15
US$ 20.46 shipping
Ships from United Kingdom to U.S.A.
Ships from United Kingdom to U.S.A.
Quantity: Over 20 available
Stock Image
The Future of Medical Device Regulation
Published by
Cambridge University Press, 2022
ISBN 10: 1108972055
ISBN 13: 9781108972055
New
Softcover
Seller: Majestic Books, Hounslow, United Kingdom
Seller rating 4 out of 5 stars
Condition: New. Print on Demand. Seller Inventory # 389451409
Buy New
US$ 85.57
US$ 8.79 shipping
Ships from United Kingdom to U.S.A.
Ships from United Kingdom to U.S.A.
Quantity: 4 available