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ISO 13485:2016—Getting Ready for Changes (Part 3)

MasterControl’s Walt Murray, a certified lead auditor in QMS standards, wraps up this series on the ISO 13485:2016 changes.

Released By MasterControl



ISO 13485 is an international management standard developed specifically for medical device manufacturers. It provides a harmonized model for creating and maintaining an effective quality management system (QMS) for the design and manufacture of medical devices. In 2016, ISO 13485 was revised to address suppliers and incorporate risk. ISO 13485:2016 explicitly requires device makers to apply a risk-based approach to all quality processes, including outsourced processes, as well as more structure to validation, verification, and design transfer. ISO 13485:2003-certified companies have three years to transition to ISO 13485:2016.
 
In the final installment of a three-part series, MasterControl’s Walt Murray, a certified lead auditor in QMS standards, wraps up the critical issues of the ISO 13485 standard for medical device manufacturers. If you haven’t yet watched part 1, you can do so here. Part 2 of this series is available here.

Also, Walt will be attending the MPO Summit in Austin. If you’re interested in scheduling an appointment with him at the event, reach out to him at walt.murray@arcexperts.com.

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