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Medical device regulation : FDA-CDRH manufacturing, policies and regulation handbook /
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 he...
| Clasificación: | Libro Electrónico |
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| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
London, United Kingdom ; San Diego, CA, United States ; Cambridge, MA, United States ; Kidlington, Oxford, United Kingdom :
Elsevier, Academic Press, an Imprint of Elsevier,
[2023]
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| Temas: | |
| Acceso en línea: | Texto completo |
| Sumario: | 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--Publisher description. |
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| Descripción Física: | 1 online resource : illustrations (some color) |
| Bibliografía: | Includes bibliographical references and index. |
| ISBN: | 9780323953535 0323953530 |