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Transition of ISO 13485 2003 to 2016

ISO 13485 is an internationally recognized quality management standard for organizations involved in the development, manufacture and distribution of medical devices. The standard was first published in 1996.  It was updated in 2003 and again recently in 2016.

The purpose of this paper is to describe the recent changes between ISO 13485:2003 & ISO 13485:2016, what the changes entail and recommendations for addressing them. This does not compare the new ISO 13485:2016 Industry Standard to Country Regulatory Body Regulations (e.g., US FDA Code of Federal Regulations Title 21 Part 820).