ANSI/AAMI/ISO 13485:2016/(R)2019
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ANSI/AAMI/ISO 13485:2016/(R)2019

Medical devices—Quality management systems—Requirements for regulatory purposes

Summary

This standard 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. Annex 3

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2016
Confirmation Date 01/01/2019
Page Count 0
Themes Quality Systems/Regulatory Affairs
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