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About This Item


Full Description

Need to stay in compliance with this standard? Purchase a checklist for guidance. (standard sold separately)

This International Standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support).

Document History

  1. AAMI/ISO 13485:2016


    Medical devices - Quality management systems - Requirements for regulatory purposes

    • Most Recent
  2. AAMI/ISO 13485:2003/(R)2009

    Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes

    • Historical Version
  3. AAMI/ISO 13485:1996

    Quality systems - Medical devices - Particular requirements for the application of ISO 9001

    • Historical Version