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AS ISO 13485:2017

M00089069

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AS ISO 13485:2017 [ Current ] Medical devices - Quality management systems - Requirements for regulatory processes

standard by Standards Australia, 12/14/2017

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Adopts ISO 13485:2016 to specify 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 and applicable regulatory requirements.

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