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AAMI Podcast 25: Changing Requirements for Quality Management Systems

Recognized by many jurisdictions around the world, the standard ANSI/AAMI/ISO 13485:2016, Medical Devices; Quality management systems; Requirements for regulatory purposes, provides structured guidance to help organizations meet regulatory requirements. In this episode, international quality and regulatory compliance consultant Eamonn Hoxey describes the major differences between the 2003 and 2016 editions of 13485. As we near…

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