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EN ISO 13485:2016 Standard

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  Keywords:

#quality #purposes #regulatory #requirements #systems

This standard is superseded by:
  •   EN ISO 13485:2016/AC:2018
  • This standard can be totally or partially supervised by:
  •   EN ISO 13485:2016/AC:2016
  •   EN ISO 13485:2016/AC:2018
  •   Directive

    Active implantable medical devices Directive (90/385/EEC)

      Last Official Journal reference

    Wednesday 14th of April 2021

      Description:

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

      Purpose

    Corrigendum for EN ISO 13485:2016

      Publication

    Friday 17th of November 2017

      Reference

    This standard supersedes the "EN ISO 13485:2012"

    Anyway is still possible use the "EN ISO 13485:2012" until March 31st, 2019

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