Certification tuv sud

ISO 13485:2016

Medical device quality management systems.

ISO 13485:2016 is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical device industry. ISO 13485:2016 is the latest update to the ISO criteria maintained for effective quality management system practices, previously revised in 2003. This long-awaited revision expands risk management, adds new safeguards, and outlines new policies for quality control in supply chain management.

The BrightInsight Quality Management System is ISO 13485:2016 certified.

More information on this widely-recognized international standard:

ISO is an independent, non-governmental international organization with a membership of 162 national standards bodies based in Geneva, Switzerland.

ISO 13485:2016 Certificate

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