Language:
    • Available Formats
    •  
    • Availability
    • Priced From ( in USD )
    • Printed Edition
    • Ships in 1-2 business days
    • $236.00
    • Add to Cart

Customers Who Bought This Also Bought

 

About This Item

 

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

    👀currently
    viewing


    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