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Full Description

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

Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

Document History

  1. AAMI/ISO 13485:2016/(R)2019


    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