Visionaria Health Systems Pvt. Ltd.- The manufacturer of Ergoptix Magnification and illumination devices, is ISO13485:2016 Certified. It concerns the "Medical Device Quality Management System" that we have in place here at RLARD. We also comply with CE norms to maintain best of the product quality standards. ERGOPTIX magnifying loupes and LED headlamps follow strict quality norms before making the products ready for final dispatch.