EN ISO 13485:2016/A11:2021
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

Standard No.
EN ISO 13485:2016/A11:2021
Release Date
2021
Published By
European Committee for Standardization (CEN)
Status
 2022-03
Latest
EN ISO 13485:2016/A11:2021

EN ISO 13485:2016/A11:2021 history

  • 2021 EN ISO 13485:2016/A11:2021 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
  • 2018 EN ISO 13485:2016/AC:2018 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
  • 2016 EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
  • 2012 EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (Incorporating corrigendum July 2012)
  • 2003 EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes Incorporating corrigendum June 2007 [Superseded: CEN EN 46003, CEN EN ISO 13488]
  • 2000 EN ISO 13485:2000 Quality Systems - Medical Devices - Particular Requirements for the Application of EN ISO 9001 Revision of EN 46001:1996; Identical to ISO 13485:1996


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