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ANSI/AAMI/ISO 13485:2016

Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes


Summary: Design a quality management system that establishes and maintains the effectiveness of your processes. This standard is meant to be used throughout a device’s life cycle, from initial concept through post-production, including final decommission and disposal. It also covers aspects such as storage, distribution, installation, and servicing, as well as the provision of associated services.

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Product Code:
13485
Date:
March 25, 2016
ISBN Number:
1-57020-604-X
Media:
Print
Pages:
46
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$133.00
List Price:
$236.00
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