• I.S. EN ISO 13485:2016&LC:2016&AC:2018

    Current The latest, up-to-date edition.

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

    Publisher:  National Standards Authority of Ireland

    Published: 

    Available Formats:  PDF - English, Hardcopy - English
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    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.

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