Big Eye Diagnostics is ISO-13485:2016 certified. This standard is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry. It indicates that the company has implemented all the quality management systems required to produce medical devices and deliver related services. ISO-13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Directives. Increasingly, ISO 13485 is being required, or is at least beneficial, in supporting regulations around the world, including the Health Canada Canadian Medical Device Regulations CMDCAS programme.
