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Document History

  1. DIN EN ISO 13485


    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) (includes Corrigendum :2018)

    • Most Recent
  2. DIN EN ISO 13485/A1 - DRAFT


    Draft Document - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019

    • Historical Version
  3. DIN EN ISO 13485 Corrigendum 1

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    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) , Corrigendum to DIN EN ISO 13485:2016-08

    • Historical Version
  4. DIN EN ISO 13485


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

    • Historical Version
  5. DIN EN ISO 13485 - DRAFT


    Draft Document - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/DIS 13485:2015); German and English version prEN ISO 13485:2015

    • Historical Version
  6. DIN EN ISO 13485 - DRAFT


    Draft Document - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/DIS 13485:2014); German version prEN ISO 13485:2014

    • Historical Version
  7. DIN EN ISO 13485


    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009) (includes Corrigendum :2012)

    • Historical Version
  8. DIN EN ISO 13485


    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009) (includes Corrigendum AC:2009)

    • Historical Version
  9. DIN EN ISO 13485


    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) (includes Corrigendum AC:2007)

    • Historical Version