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    I.S. EN ISO 13485:2003

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2016)

    Available format(s):  Hardcopy, PDF

    Superseded date:  08-10-2018

    Language(s):  English

    Published date:  31-12-2002

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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    Abstract - (Show below) - (Hide below)

    This International Standard specifies requirements for a quality management system where an organization
    needs to demonstrate its ability to provide medical devices and related services that consistently meet
    customer requirements and regulatory requirements applicable to medical devices and related services.

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

    Committee TC 210
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By
    Supersedes
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