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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Full Description
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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.
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.
Document History
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AAMI/ISO 13485:2016/(R)2019
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Medical devices - Quality management systems - Requirements for regulatory purposes- Most Recent
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AAMI/ISO 13485:2003/(R)2009
Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes- Historical Version
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AAMI/ISO 13485:1996
Quality systems - Medical devices - Particular requirements for the application of ISO 9001- Historical Version
