AAMI/ISO 13485:2016/(R)2019

Medical devices - Quality management systems - Requirements for regulatory purposes

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 03/25/2016

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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.

Product Details

Published:: 03/25/2016
ISBN(s):: 157020604X
ANSI:: ANSI Approved
Number of Pages:: 50
File Size:: 1 file , 610 KB
Note:: This product is unavailable in Ukraine, Russia, Belarus