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020			_a9783030044626
024	7		_a10.1007/978-3-030-04462-6 _2doi
040			_bspa _dES-MaUEC _cES-MaUEC
050		4	_aR855.3 2019 EB
090		4	_aR856-857
100	1		_aHalt, Gerald B., _eautor _4aut _4http://id.loc.gov/vocabulary/relators/aut _cJr. _9670125
245	1	0	_aFDA and Intellectual Property Strategies for Medical Device Technologies _cby Gerald B. Halt, John C. Donch, Amber R. Stiles, Lisa Jenkins VanLuvanee, Brandon R. Theiss, Dana L. Blue.
264		1	_aCham _bSpringer International Publishing : _bImprint: Springer _c2019.
300			_a1 recurso en línea (XXIV, 333 páginas) _b35 ilustraciones, 5 ilustraciones a color
336			_2rdacontent _aTexto _btxt
337			_2rdamedia _aelectrónico _bc
338			_2rdacarrier _arecurso electrónico _bcr
347			_atext file _bPDF
490	0		_aEngineering (Springer-11647)
505	0		_aIntroduction -- Development of A New Medical Device -- Determining If A Medical Device Technology Is FDA Regulated -- Basic FDA Regulatory Requirements For Medical Devices -- Other Regulatory Consideration For Medical Devices -- Benefits of Having FDA Approval -- Patents -- Trademarks and Trade Dress -- Trade Secrets -- Copyrights In Medical Device Technology -- Design Protection For Medical Devices -- Intellectual Property Issues in Medical Device Labeling and Marketing -- Enforcement, Infringement and Monetization of Intellectual Property Rights -- Successful Implementation of a Medical Device Company's IP Strategy -- Tips for Avoiding and Preventing Intellectual Property Problems -- Successful Implementation of a Medical Device Company's Regulatory Strategy -- Tips for Avoiding and Preventing Regulatory Problems -- Potential Combined IP and Regulatory Pitfalls.
520	3		_aThis 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. 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.
650		7	_2embne _aTecnología médica _9150466
700	1		_aBlue, Dana L. _eautor _4aut _4http://id.loc.gov/vocabulary/relators/aut
700	1		_aDonch, John C. _eautor _4aut _4http://id.loc.gov/vocabulary/relators/aut
700	1		_aStiles, Amber R. _eautor _4aut _4http://id.loc.gov/vocabulary/relators/aut
700	1		_aTheiss, Brandon R. _eautor _4aut _4http://id.loc.gov/vocabulary/relators/aut
700	1		_aVanLuvanee, Lisa Jenkins. _eautor _4aut _4http://id.loc.gov/vocabulary/relators/aut
776	0	8	_iPrinted edition: _z9783030044619
776	0	8	_iPrinted edition: _z9783030044633
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://doi.org/10.1007/978-3-030-04462-6 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
942			_2lcc _cLE
988			_aPrimersemestre_2019_Engineering
998			_aSI _cm _dz _feng _ggw _h0 _b07/2019 _ejf _zSI