UNE-EN ISO 13485:2018
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016). (Consolidated version)

Standard No.
UNE-EN ISO 13485:2018
Release Date
2018
Published By
ES-UNE
Status
Replace By
UNE-EN ISO 13485:2018/A11:2022
Latest
UNE-EN ISO 13485:2018/A11:2022

UNE-EN ISO 13485:2018 history

  • 2022 UNE-EN ISO 13485:2018/A11:2022 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
  • 2018 UNE-EN ISO 13485:2018 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016). (Consolidated version)
  • 2013 UNE-EN ISO 13485:2013 Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009)
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016). (Consolidated version)



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