SINGAPORE – 28-Jan-2019 – Leben Care Technologies Pte. Ltd., a Deep Learning AI healthcare startup, developing solutions to tackle the global problem of avoidable blindness, announced today that the Company has received ISO 13485:2016 certification for its Quality Management System (QMS) following review by the TÜV Rheinland. ISO 13485:2016 is an internationally recognized quality standard specific to the medical device industry. ISO 13485:2016 demonstrates Leben’s commitment to the highest level of medical device quality controls and to meeting customer and international regulatory expectations.
Imran Akthar, Founder and CTO, for Leben Care commented, ”Very excited and proud to have certified our Quality process compliant with ISO 13485:2016.”
Nitin Srivastava, Co-Founder and CEO, for Leben Care commented, “Implementation of ISO 13485:2016 is a key milestone in our journey to become fully aligned and complaint with global health care regulatory requirements. We are looking forward to support the global diabetes community with the Leben Netra.AI Platform”
About ISO 13485:2016
ISO 13485:2016 has been harmonized to the European Medical Devices Directives: MDD, AIMDD and IVDD. EN ISO 13485:2016 now replaces the previous version of the standard, EN ISO 13485:2012. Standard harmonization allows manufacturers to use their compliance to the standard as evidence of conformity to the requirements of relevant legislation.
Netra.AI platform provides valuable, automated, Clinical Insights on retina ,blood vessels and lesions, aiding Primary care workers in providing supportive information to Ophthalmologist / retina specialist and other healthcare professionals using deep machine learning . The solutions enhance clinical assessments, treatment planning, and disease progression monitoring of patients with retina conditions, such as Diabetic Retinopathy, Glaucoma and Age Related Macular Degeneration.
About Netra Screen
Netra Screen is an comprehensive retinal screening solution, which is designed to transform Retinal Screening (in individual outpatient settings or mass screening platforms) with a scalable, low cost, fast and accurate automated risk profiling powered by Netra.AI Platform.
About Leben Care
Leben Care Technologies Pte. Ltd., is an Artificial Intelligence (AI) Healthcare company based out of Singapore, focused on improving quality of diagnosis across the areas of life sciences. Leben Care’s first flagship AI Platform Netra.AI uses cutting edge Algorithms with a 4 step Deep Convolutional Neural Network (DCNN). Algorithm is developed under the guidance and mentorship of some of the leading retina experts at Sankara Eye Foundation, India. Netra.AI enables automated and point of care Retinal Image Analysis by 1) Reducing incidence of blindness by timely identification of patients at risk and 2) Offering insights to medical practitioners thus enabling improved diagnostic outcome . Please visit www.leben.ai for more information.