Synopsis
Investigates the FDA approval process as it pertains to medical device technology
Address some of the major FDA hurdles that medical device innovators often face while seeking approval
Discusses the interplay between FDA regulatory review of medical device technology and intellectual property strategy
Explores the benefits of protecting, managing and enforcing intellectual property obtained for medical device technology so that innovators can obtain the best possible commercial results from their IP ownership
Uses real case studies to illustrate concepts covered
Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.
À propos de l?auteur
Gerald B. Halt, Jr. is a Patent Attorney, shareholder and President at Volpe & Koenig, P.C. Jay focuses his practice on securing, licensing and enforcing the value of intellectual property rights. His practice includes litigation, inter partes matters, administrative proceedings, licensing of trademarks and technology, validity opinions and due diligence reviews. Jay also serves as President of the firm. While his experience with technology is varied, Jay's particular area of focus is on electrical, electronic and computer software technologies, including optical and wireless communication systems, computers, communication system protocols, microwave systems and components, optical barcode scanners, fiber optic systems and semiconductor devices.
Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.
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FDA and Intellectual Property Strategies for Medical Device Technologies.
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Cham, Springer., 2019
ISBN 10 : 3030044610
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XXIV, 333 p. Hardcover. Versand aus Deutschland / We dispatch from Germany via Air Mail. Einband bestoßen, daher Mängelexemplar gestempelt, sonst sehr guter Zustand. Imperfect copy due to slightly bumped cover, apart from this in very good condition. Stamped. Sprache: Englisch. N° de réf. du vendeur 9288JB
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FDA and Intellectual Property Strategies for Medical Device Technologies
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ISBN 13 : 9783030044619
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Buch. Etat : Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA and 510(k) application processes. In the second portion of this book, readers are introduced to the various types of intellectual property rights that are available for medical device technology inventions and innovations, and can explore ways to overcome unique intellectual property challenges faced by many medical device technology innovators. In the third portion of the book, specific strategies are discussed to navigate the interface between the FDA regulatory process and the process of obtaining intellectual property protection.This book also includes a number of descriptive examples, case studies and scenarios to illustrate the topics discussed, and is intended for use by medical device designers, developers and innovators. 360 pp. Englisch. N° de réf. du vendeur 9783030044619
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Buch. Etat : Neu. FDA and Intellectual Property Strategies for Medical Device Technologies | Gerald B. Halt (u. a.) | Buch | xxiv | Englisch | 2019 | Springer Nature Switzerland | EAN 9783030044619 | Verantwortliche Person für die EU: Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg, juergen[dot]hartmann[at]springer[dot]com | Anbieter: preigu Print on Demand. N° de réf. du vendeur 114775884
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ISBN 13 : 9783030044619
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Buch. Etat : Neu. Neuware -This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA and 510(k) application processes. In the second portion of this book, readers are introduced to the various types of intellectual property rights that are available for medical device technology inventions and innovations, and can explore ways to overcome unique intellectual property challenges faced by many medical device technology innovators. In the third portion of the book, specific strategies are discussed to navigate the interface between the FDA regulatory process and the process of obtaining intellectual property protection.This book also includes a number of descriptive examples, case studies and scenarios to illustrate the topics discussed, and is intended for use by medical device designers, developers and innovators.Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg 360 pp. Englisch. N° de réf. du vendeur 9783030044619
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FDA and Intellectual Property Strategies for Medical Device Technologies
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Springer International Publishing, Springer Nature Switzerland, 2019
ISBN 10 : 3030044610
ISBN 13 : 9783030044619
Neuf
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Buch. Etat : Neu. Druck auf Anfrage Neuware - Printed after ordering - This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA and 510(k) application processes. In the second portion of this book, readers are introduced to the various types of intellectual property rights that are available for medical device technology inventions and innovations, and can explore ways to overcome unique intellectual property challenges faced by many medical device technology innovators. In the third portion of the book, specific strategies are discussed to navigate the interface between the FDA regulatory process and the process of obtaining intellectual property protection.This book also includes a number of descriptive examples, case studies and scenarios to illustrate the topics discussed, and is intended for use by medical device designers, developers and innovators. N° de réf. du vendeur 9783030044619
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