ISO 13485: 2016 Part 1: Getting Ready for Changes

November 17, 2015

"In this first video of a three-part series, Walt Murray gives an overview of the new quality management system (QMS) standard ISO 13485 version 2016. Learn the essentials of the new edition of the standard, how it will affect your medical device company, and how the new version of 13485 differs from previous versions.

Walt explains how the ISO 13485 standard is changing and when the new standard will take effect. He illustrates new concepts and elements of ISO 13485:2016, including its emphasis on risk and opportunity orientations; a new convention for high-level systems (HSL); and how the new standard will be used in the full life cycle of the device. 

Device manufacturers will need to consider and weigh the new standard’s similarities and differences and create a checklist in order to develop their new systems to comply with ISO 13485:2016. Finally, Walt explains how companies can best prepare themselves to make the transition.

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