Latest News Mikajaki Achieves ISO 13485:2016 Milestone By Staff Wednesday, May 5, 2021 12:15 AM PLAN LES OUATES, Switzerland—Mikajaki, SA, based here, announced that it has met another milestone in its development with the certification of its quality management system (QMS) under ISO:13485:2016. The certification follows the company’s first CE mark (Certificate of Conformity) for its EyeLib diagnostic system in September 2020. This achievement means that the company’s QMS system meets the most current regulatory requirements specific to the design, manufacturing, and distribution of medical devices. “The Mikajaki team has worked tirelessly to achieve this ISO certification, often under less-than-ideal circumstances due to COVID-19 restrictions,” said Jacky Hochner, Mikajaki’s CEO. “To achieve ISO:13485, with no major findings or non-conformities, validates this hard work and sets the stage for scaling up manufacturing.”Mikajaki describes EyeLib as “a completely self-operated station for comprehensive and automated pre-diagnosis and efficient triage of patients.” EyeLib incorporates multiple diagnostic devices into the robotic platform. The fully automated system allows patients to check in with their insurance card, identify themselves and then move onto the EyeLib for testing. The information gathered is then safely transmitted to the clinic’s EMR system for use by the ophthalmologist and clinic staff.The first EyeLib is in place at IenaVision Center in Paris, the medical practice of company co-founder, Michael Assouline, MD, PhD. An additional EyeLib is in place at Institut Ophtalmologique de l'Ouest Jules Verne in Nantes, one of the largest ophthalmic centers in Europe. Additional EyeLibs will now be manufactured for partner centers in France and other European countries, the company said in a statement.Mikajaki said that now that the ISO:13485 certification in place, its team of experienced robotic, software and AI experts is now focused on delivering the pre-orders for partner centers in France and Europe.Michael Assouline, MD, PhD, together with Jacky Hochner, founded Mikajaki in 2018 with the vision to re-engineer the eye health care diagnostics process. They’ve used their combined 25 years of experience in surgical practice and ophthalmic device commercialization, to design a novel approach to ophthalmic diagnostics. Thanks to their extensive network of professionals, Assouline and Hochner have succeeded in rapidly setting up critical engineering, medical, manufacturing and financial partnerships, which support their project.