Safety and quality for medical devices abides by non-negotiable standards laid out by an international organization (ISO) of over 160 national standards bodies.  ISO 13485 is a directive for the regulation of medical devices and quality systems.  Bodies often have unique procedures and guidance to meed the ISO 13485 standards, all of which must be met in order to sell devices within markets governed by each body.  Some of the larger bodies include the United States, European Union, and Canada.

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