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:

  • This certification demonstrates to our customers that our company operates a cutting-edge Quality Management System for software development services, such as developing and hosting Software as a Medical Device.
  • To achieve certification, our processes, documentation and quality culture were audited independently in accordance with the ISO 13485:2016 standard.
  • The certification builds on the principles of FDA’s quality system regulations and is recognized internationally.
  • The ISO certification demonstrates that our medical-grade BrightInsight Platform was built with a state-of-the-art Quality Management System.
  • BrightInsight’s Agile software development process was also part of the certification — critical in proving the company meets the stringent requirements of ISO 13485:2016 while continually improving its BrightInsight software. 

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

ISO 13485:2016 Certificate