• SANS 13485:2018

    Current The latest, up-to-date edition.

    Medical devices — Quality management systems — Requirements for regulatory purposes

    Available format(s):  Hardcopy

    Language(s):  English

    Published date:  13-03-2018

    Publisher:  South African Bureau of Standards

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    Abstract - (Show below) - (Hide below)

    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 TC 1039
    Document Type Standard
    Publisher South African Bureau of Standards
    Status Current
    Supersedes
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