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Part II: US FDA Quality System Regulation Vs ISO 13485:2016

This tool clarifies the corresponding relationships between the ISO 13485:2016 (medical devices, quality management systems) requirements for regulatory purposes clauses and the US Food and Drug Administration (FDA) quality system regulation. Use this free white paper to ensure your quality management system meets applicable requirements for both ISO 13485:2016 and the US FDA. Download to find out more. For Part I, click here.

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DOWNLOAD WHITEPAPER

Part II: US FDA Quality System Regulation Vs ISO 13485:2016

This tool clarifies the corresponding relationships between the ISO 13485:2016 (medical devices, quality management systems) requirements for regulatory purposes clauses and the US Food and Drug Administration (FDA) quality system regulation. Use this free white paper to ensure your quality management system meets applicable requirements for both ISO 13485:2016 and the US FDA. Download to find out more. For Part I, click here.

Download to find out more.

DOWNLOAD

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