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    S.R. CEN/TR 17223:2018

    Current The latest, up-to-date edition.

    GUIDANCE ON THE RELATIONSHIP BETWEEN EN ISO 13485: 2016 (MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES) AND EUROPEAN MEDICAL DEVICES REGULATION AND IN VITRO DIAGNOSTIC MEDICAL DEVICES REGULATION

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2018

    Publisher:  National Standards Authority of Ireland

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    Table of Contents - (Show below) - (Hide below)

    National Foreword
    European Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Relationship between the European Regulations
      for Medical Devices and in vitro Diagnostic
      Medical Devices and the clauses of EN ISO 13485

    Abstract - (Show below) - (Hide below)

    Gives guidance on the relationship between EN ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes and the requirements in EU Regulation 2017/745 on Medical Devices and EU Regulation 2017/746 on in vitro Diagnostic Medical Devices.

    General Product Information - (Show below) - (Hide below)

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
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