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  • UNE-EN ISO 13485:2018

    Current The latest, up-to-date edition.

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

    Available format(s):  Hardcopy, PDF

    Language(s):  Spanish, Castilian, English

    Published date:  25-07-2018

    Publisher:  Asociacion Espanola de Normalizacion

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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 and applicable regulatory requirements.

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

    Committee CTN 111
    Document Type Standard
    Product Note THIS STANDARD ALSO REFERS TO: GHTF/SG1/N055:2009 ,GHTF/SG5/N4:2010 ,GHTF/SG1/N70:2011 ,GHTF/SG1/N071:2012.
    Publisher Asociacion Espanola de Normalizacion
    Status Current
    Supersedes
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