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About This Item

 

Document History

  1. DANSK DS/EN ISO 13485

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    Medical devices – Quality management systems – Requirements for regulatory purposes

    • Most Recent
  2. DANSK DS/EN ISO 13485


    Medical devices – Quality management systems – Requirements for regulatory purposes

    • Historical Version
  3. DANSK DS/EN ISO 13485


    Medical devices - Quality management systems - System requirements for regulatory purposes

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. DANSK DS/EN ISO 13485/AC


    Medical devices – Quality management systems – Requirements for regulatory purposes

  2. DANSK DS/EN ISO 13485/AC


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

  3. DANSK DS/EN ISO 13485/A11


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