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  • SN EN ISO 13485:2016

    Current The latest, up-to-date edition.

    MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2016)

    Available format(s):  Hardcopy

    Language(s): 

    Published date:  01-03-2016

    Publisher:  Swiss Standards

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    Abstract - (Show below) - (Hide below)

    ISO 13485:2016 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.

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    Committee INB/NK 410
    Development Note Supersedes SN EN ISO 13488. (09/2004) Supersedes SN EN 46003. (11/2007)
    Document Type Standard
    Publisher Swiss Standards
    Status Current
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