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EN ISO 13485:2016/AC:2016 Standard

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  Keywords:

#quality #purposes #regulatory #requirements #systems

  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

  Cessation

This standard has been withdrawn on 2021-09-30

  Correction

This standard is a correction for "EN ISO 13485:2016"

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EN ISO 13408-4:2011

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EN ISO 13408-5:2011

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