Skip to content
Please enter a keyword to search

  • GOST ISO 13485:2017

    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:  30-06-2017

    Publisher:  Interstandard (Russia)

    Add To Cart

    Abstract - (Show below) - (Hide below)

    This standard establishes requirements for a quality management system in cases where an organization needs to demonstrate the ability to supply medical devices and provide related services that meet customer requirements and applicable regulatory requirements.

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

    Document Type Standard
    Product Note This standard also identical to GOST R 54881, GOST R 58454, GOST R 59767, GOST R 59768, GOST R 59769, GOST R 59770, GOST R 59921.5, GOST R 59921.8, GOST R 70393, GOST R 70478, GOST R ISO 11737-1
    Publisher Interstandard (Russia)
    Status Current
    Supersedes
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective