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    ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the previous version of ISO 9001, ISO 9000 2008 process-based model for a regulated medical device manufacturing environment.

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  • ISO 13485Quality Management Systems For Medical

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  • ISOISO 13485 — Medical devices

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