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

Medical devices—Quality management systems—Requirements for regulatory purposes

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.

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Product Code:
134852019PDF
Date:
October 17, 2019
ISBN Number:
1-57020-604-X
Media:
PDF
Pages:
50
Available for Immediate Download
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$133.00
List Price:
$236.00
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$236.00
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