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Publications PLUS 13485 (1st ed. pub. 2006)

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PLUS 13485 (1st ed. pub. 2006) - The ISO 13485 Essentials - A Practical Handbook for Implementing the ISO 13485 Standard for Manufacturers of Medical Devices

Année de publication:

  • 2006

Nombre total de pages :

196

Éditeur:

  • CSA

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    CAN/CSA-ISO 14971-F07 (C2017)

    CAN/CSA-ISO 14971-F07 (C2017) - Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux (norme ISO 14971:2007 adoptée, deuxième édition, 2007-03-01)

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    PLUS 14971 (2nd ed. pub. 2007)

    PLUS 14971 (2nd ed. pub. 2007) - The ISO 14971:2007 Essentials - A Practical Handbook for Implementing the ISO 14971 Standard for Medical Devices

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Preface

The primary objective of this Handbook is to provide both novice and experienced quality practitioners with a concise, user-friendly guide to understanding and implementing the requirements of ISO 13485 as it relates to their quality management system (QMS).

The Canadian National Standard CAN/CSA-ISO 13485:03 is identical to its international counterpart, ISO 13485:03. To facilitate reading, the CAN/CSA prefix and year of issue have not been systematically included in the references to the Standard throughout this Handbook. Similarly, when ISO 9000 is used in the text, it refers to the 2000 edition. Please refer to the bibliography for the full title and designation of these Standards

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