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Sinopsis
Medical Device Design: Innovation from Concept to Market, Second Edition provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones; this book fills that need. It addresses medical devices' regulatory (FDA and EU) requirements, shows the essential methodologies medical designers must understand to ensure their products meet requirements, and brings together proven design protocols, thus enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace.
This book is unique because it takes the reader through the process of medical device development, from very early stages of conceptualization, to commercialization on the global market. This rare resource can be used by both professionals and newcomers to device design.
- Provides a reference to standards and regulations that have been updated, including ISO 13485:2016, FDA regulations and the European Medical Device Regulation
- Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more
- Presents additional content around software and biocompatibility concerns
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Acerca del autor
Professor Ogrodnik is a Chartered Mechanical Engineer, a Member of the Institution of Engineering Designers and a Fellow (regional) of the Royal Society of Medicine, an Honorary Consultant at the Royal Stoke University Hospital. For over 20 years he has conducted research into optimising the treatment of tibial fractures. Using this research base he has enhanced the application of engineering design principles to the solution of medical devices, his book Medical Devices Design is a core text in core R&D departments.
He has founded two medical devices companies (one manufactures and sells medical devices to the NHS and beyond) and is named inventor on numerous patents. He was a founding director of the University spinout Intelligent Orthopaedics Ltd, and is a founding partner of Metaphysis LLP. Through this corporate involvement Professor Ogrodnik has an understanding of the realities of applied research for industry; for example he was a member of the AWM Healthcare Technologies cluster opportunity group.
"Sobre este título" puede pertenecer a otra edición de este libro.
- EditorialAcademic Press
- Año de publicación2019
- ISBN 10 0128149620
- ISBN 13 9780128149621
- EncuadernaciónTapa blanda
- IdiomaInglés
- Número de edición2
- Número de páginas538
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Medical Device Design: Innovation from Concept to Market
Publicado por
Elsevier Science Publishing Co Inc, 2019
ISBN 10: 0128149620
ISBN 13: 9780128149621
Nuevo
Tapa blanda
Librería: Kennys Bookshop and Art Galleries Ltd., Galway, GY, Irlanda
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Condición: New. 2019. 2nd Edition. Paperback. . . . . . Nº de ref. del artículo: V9780128149621
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Medical Device Design : Innovation from Concept to Market
Publicado por
Elsevier Science Publishing Co Inc Okt 2019, 2019
ISBN 10: 0128149620
ISBN 13: 9780128149621
Nuevo
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Librería: AHA-BUCH GmbH, Einbeck, Alemania
Calificación del vendedor: 5 de 5 estrellas
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Cantidad disponible: 1 disponibles