Stitcher for Podcasts

Get the App Open App
Bummer! You're not a
Stitcher Premium subscriber yet.
Learn More
Start Free Trial
$4.99/Month after free trial

Episode Info

Episode Info:

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 the end of a three-year transition period for medical device developers and manufacturers to comply with requirements set forth in the 2016 edition of the standard, Hoxey discusses how the new updated version clarifies expectations for manufacturers, providing a much more global, comprehensive, and harmonized approach to meeting requirements.

Learn more at


Discover more stories like this.

Like Stitcher On Facebook


Episode Options

Listen Whenever

Similar Episodes

Related Episodes