ANSI/AAMI/ISO 13485:2016 (R2019)

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Medical devices - Quality management systems - Requirements for regulatory purposes.

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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Association for the Advancement of Medical Instrumentation [aami]

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Medical devices - Quality management systems - Requirements for regulatory purposes.

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ANSI/AAMI/ISO 13485:2016 (R2019)

Medical devices - Quality management systems - Requirements for regulatory purposes.

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