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Itay Abuhav
ISO 13485:2016
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4118666ISO 13485:2016https://www.gandhi.com.mx/iso-134852016-9781351000772/phttps://gandhi.vtexassets.com/arquivos/ids/3218891/a04d75c5-af41-4928-93d7-14706919dab9.jpg?v=63838504795493000042584258MXNCRC PressInStock/Ebooks/<p>Summary:</p><p>This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more than 800-page length, the author has specifically designed its contents to maximize usability for the reader with a table of contents identical to that of the ISO standard itself, which enables easy navigation and orientation.</p><p>Pragmatic in style and down to earth in tone, this book draws real-life examples and case-studies from the authors many years of experience in consulting to illustrate even the most complex of ISO 13485:2016 standard requirements and their implementation. Identifying relevant requirements and how they harmonize with quality management systems, developing processes for design and development, as well as product realization and validation are just a few of the issues covered in-depth by this publication.</p><p>In addition, the author constantly reviews the distinctive characteristics and aspects of the medical device manufacturing industry, so that the reader can also appreciate the subject of this book in an everyday context.</p><p>Features:</p><ul><li>A pragmatic and down to earth approach towards the readers understanding of ISO 13485:2016 standard requirements implementation.</li><li>Uses examples and cases from real-life based on the authors many years of experience in quality management.</li><li>A table of contents structured identically to that of ISO 13485:2016 itself, allowing easier navigation and orientation for the reader.</li><li>Emphasises guidance for ISO 13495:2016 standard requirements which are difficult to interpret and implement</li><li>Constantly reviews the aspect of medical device industry characteristics and distinctive so the reader can reflect the content with its daily work.</li></ul>...4054615ISO 13485:201642584258https://www.gandhi.com.mx/iso-134852016-9781351000772/phttps://gandhi.vtexassets.com/arquivos/ids/3218891/a04d75c5-af41-4928-93d7-14706919dab9.jpg?v=638385047954930000InStockMXN99999DIEbook20189781351000772_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9781351000772_<p>Summary:</p><p>This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more than 800-page length, the author has specifically designed its contents to maximize usability for the reader with a table of contents identical to that of the ISO standard itself, which enables easy navigation and orientation.</p><p>Pragmatic in style and down to earth in tone, this book draws real-life examples and case-studies from the authors many years of experience in consulting to illustrate even the most complex of ISO 13485:2016 standard requirements and their implementation. Identifying relevant requirements and how they harmonize with quality management systems, developing processes for design and development, as well as product realization and validation are just a few of the issues covered in-depth by this publication.</p><p>In addition, the author constantly reviews the distinctive characteristics and aspects of the medical device manufacturing industry, so that the reader can also appreciate the subject of this book in an everyday context.</p><p>Features:</p><ul><li><p>A pragmatic and down to earth approach towards the readers understanding of ISO 13485:2016 standard requirements implementation.</p><p>Uses examples and cases from real-life based on the authors many years of experience in quality management.</p><p>A table of contents structured identically to that of ISO 13485:2016 itself, allowing easier navigation and orientation for the reader.</p><p>Emphasises guidance for ISO 13495:2016 standard requirements which are difficult to interpret and implement</p><p>Constantly reviews the aspect of medical device industry characteristics and distinctive so the reader can reflect the content with its daily work. </p></li></ul>(*_*)9781351000772_<p>Summary:</p><p>This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more than 800-page length, the author has specifically designed its contents to maximize usability for the reader with a table of contents identical to that of the ISO standard itself, which enables easy navigation and orientation.</p><p>Pragmatic in style and down to earth in tone, this book draws real-life examples and case-studies from the authors many years of experience in consulting to illustrate even the most complex of ISO 13485:2016 standard requirements and their implementation. Identifying relevant requirements and how they harmonize with quality management systems, developing processes for design and development, as well as product realization and validation are just a few of the issues covered in-depth by this publication.</p><p>In addition, the author constantly reviews the distinctive characteristics and aspects of the medical device manufacturing industry, so that the reader can also appreciate the subject of this book in an everyday context.</p><p>Features:</p><ul><li>A pragmatic and down to earth approach towards the readers understanding of ISO 13485:2016 standard requirements implementation.</li><li>Uses examples and cases from real-life based on the authors many years of experience in quality management.</li><li>A table of contents structured identically to that of ISO 13485:2016 itself, allowing easier navigation and orientation for the reader.</li><li>Emphasises guidance for ISO 13495:2016 standard requirements which are difficult to interpret and implement</li><li>Constantly reviews the aspect of medical device industry characteristics and distinctive so the reader can reflect the content with its daily work.</li></ul>...9781351000772_CRC Presslibro_electonico_f8de3847-8c0f-3741-a6ef-3c82cee05711_9781351000772;9781351000772_9781351000772Itay AbuhavInglésMéxicohttps://getbook.kobo.com/koboid-prod-public/taylorandfrancis-epub-618e138d-847a-406e-ab0c-5581483dc9b5.epub2018-05-11T00:00:00+00:00CRC Press