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About This Item

 

Full Description

Provides guidance on the application of requirements contained in ISO 13485:2003, including detailed guidance related to process validation, design control, and quality planning.
 

Document History

  1. AAMI/ISO TIR14969:2004

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    Quality management systems - Medical devices - Guidance on the application of ISO 13485:2003

    • Most Recent
  2. AAMI/ISO 14969


    Quality systems -- Medical devices -- Guidance on the application of ISO 13485 and ISO 13488

    • Historical Version