Quick Take: Olleyes, Inc. has earned the International Organization for Standardization (ISO) 13485:2016 certification from SGS.
Close Up: The certification demonstrates the company's compliance with medical device quality management system requirements under the Medical Device Single Audit Program (MDSAP). Olleyes is a privately held medical software company committed to developing efficient and productive diagnostic technology. Their products are designed for the office and home evaluation of patients with eye diseases like glaucoma, diabetic retinopathy, and age-related macular degeneration.
Vital Stats: ISO/MDSAP certifications emphasize a key achievement in the international expansion for Olleyes' FDA-cleared VisuALL VRP. The VisuALL VRP leverages virtual reality (VR), artificial intelligence (AI), and dynamic matrix eye tracking to enable eyecare providers to test their entire patient base comfortably and efficiently. With DynamicMatrix, the VisuALL ETS stimulus remains consistent with the same region of the retina, regardless of a patient's ability to fixate or remain fixated. It also vastly increases the precision of the data and improves the doctors' ability to confidently diagnose their patients.
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