ANSI/AAMI 13485:2003 (R2009)

ANSI/AAMI/ISO 13485:2003 (R2009)

Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes Association for the Advancement of Medical Instrumentation/International Org. for Standardization / 18-Jun-2003

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Specifies requirements for a quality management system where an organization needs todemonstrate its ability to provide medical devices and related services that consistently meetcustomer requirements and regulatory requirements applicable to medical devices and relatedservices.



Keywords: medical device, quality management system

This product is related to: SEPT ANSI/AAMI/ISO 13485:2003 CHECKLIST - Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
IEC 62304 Ed. 1.0 b:2006 - Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
FDA GUIDANCE 4 - Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
SEPT IEC 62304 CHECKLIST - Prod 40 - Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
This product replaces:ANSI/AAMI/ISO 13485:1996 - Quality systems - Medical devices - Particular requirements for the application of ISO 9001
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ANSI/AAMI/ISO 13485:2003 (R2009)
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