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ISO 13485:2016 : a complete guide to quality management in the medical device industry /
"This book will be a substantial revision, which will reflect the new version of the ISO 13485:2016. This represents the standard protocols that all medical device manufacturers must follow, in the fabrication of their products. It will focus on changes in the structure of the quality managemen...
| Clasificación: | Libro Electrónico |
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| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Boca Raton :
CRC Press, Taylor & Francis,
[2018]
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| Edición: | Second edition. |
| Temas: | |
| Acceso en línea: | Texto completo |
| Sumario: | "This book will be a substantial revision, which will reflect the new version of the ISO 13485:2016. This represents the standard protocols that all medical device manufacturers must follow, in the fabrication of their products. It will focus on changes in the structure of the quality management system; change in the documentation for quality managemeent systems and finally, present the different methods of implementation of the standard requirements within the organization. This new version was initiated in 2016, thus all apprpriate enterprises using the old standard must convert to the new version, now available. The Second Edition will clarify, explain and demonstrate the new version."-- |
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| Notas: | Includes index. |
| Descripción Física: | 1 online resource (xiii, 877 pages) |
| Bibliografía: | Includes bibliographical references and index. |
| ISBN: | 9781351000772 1351000772 9781351000796 1351000799 9781351000789 1351000780 9781523118106 1523118105 |