{"id":8393,"date":"2026-08-12T09:30:00","date_gmt":"2026-08-12T07:30:00","guid":{"rendered":"https:\/\/wivivision.com\/?p=8393"},"modified":"2026-08-12T09:30:01","modified_gmt":"2026-08-12T07:30:01","slug":"wivi-vision-obtains-class-iia-medical-device-certification","status":"publish","type":"post","link":"https:\/\/wivivision.com\/pt\/wivi-vision-obtains-class-iia-medical-device-certification\/","title":{"rendered":"WIVI Vision obt\u00e9m certifica\u00e7\u00e3o de dispositivo m\u00e9dico de Classe IIa"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"8393\" class=\"elementor elementor-8393\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fc67843 e-flex e-con-boxed e-con e-parent\" data-id=\"fc67843\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-54d7931 elementor-widget elementor-widget-text-editor\" data-id=\"54d7931\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"PDq2pG_selectionAnchorContainer\" data-start=\"62\" data-end=\"257\">At WIVI Vision, we are incredibly proud to have obtained <strong data-start=\"119\" data-end=\"161\">Class IIa medical device certification<\/strong>, <strong>making WIVI one of the <a href=\"https:\/\/lookvision.es\/wivi-vision-entre-las-primeras-soluciones-de-terapia-visual-certificadas-como-producto-sanitario-de-clase-iia\" target=\"_blank\" rel=\"noopener\">first vision therapy solutions<\/a> in Spain to achieve this classification.<\/strong><\/p><p data-start=\"259\" data-end=\"465\">This milestone represents an important step forward for WIVI and reflects our commitment to developing healthcare technology in line with the highest standards of safety, performance, and clinical evidence.<\/p><p data-start=\"467\" data-end=\"717\">Until now, our technology had been certified as a Class I medical device. Moving to Class IIa means meeting a more demanding regulatory framework and successfully completing a conformity assessment process carried out by an independent notified body.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-baae309 elementor-widget elementor-widget-heading\" data-id=\"baae309\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">A more demanding regulatory framework for greater assurance<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-18cf768 elementor-widget elementor-widget-text-editor\" data-id=\"18cf768\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"PDq2pG_selectionAnchorContainer\" data-start=\"783\" data-end=\"1076\">Class IIa certification confirms compliance with the requirements established by the European Medical Device Regulation and involved an assessment of different areas of WIVI, including technical documentation, risk management, and the processes implemented throughout the solution\u2019s lifecycle.<\/p><p data-start=\"1078\" data-end=\"1363\"><strong>For eye care professionals and patients, this process provides additional assurance regarding the safety and performance of the <a href=\"https:\/\/wivivision.com\/pt\/discover-wivi\/\" target=\"_blank\" rel=\"noopener\">technology.<\/a><\/strong> It also strengthens confidence in a solution designed with mechanisms to identify, control, and minimize potential risks associated with its use.<\/p><p data-start=\"1365\" data-end=\"1650\">Behind every assessment, every therapy session, every measurement, and every program developed with WIVI is a rigorous process subject to external oversight.<strong> It is part of our commitment to ensuring that innovation in healthcare is always accompanied by the highest level of standards.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-53fef24 elementor-widget elementor-widget-heading\" data-id=\"53fef24\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">A double endorsement for WIVI: Class IIa and ISO 13485<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f4d2768 elementor-widget elementor-widget-text-editor\" data-id=\"f4d2768\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"PDq2pG_selectionAnchorContainer translation-block\" data-start=\"1711\" data-end=\"1919\">A obten\u00e7\u00e3o da <strong data-start=\"1730\" data-end=\"1772\">certifica\u00e7\u00e3o de dispositivos m\u00e9dicos<\/strong> da<strong data-start=\"1730\" data-end=\"1772\"> Classe IIa<\/strong> coincide <strong data-start=\"1730\" data-end=\"1772\">tamb\u00e9m<\/strong> com a <strong data-start=\"1797\" data-end=\"1849\">renova\u00e7\u00e3o da <a href=\"https:\/\/www.optimoda.es\/economia\/wivi-vision-obtiene-la-certificacion-iso-13485-y-refuerza-su-compromiso-con-la-calidad-sanitaria\/\" target=\"_blank\" rel=\"noopener\">certifica\u00e7\u00e3o ISO 13485<\/a> da WIVI Vision<\/strong> para o seu sistema de gest\u00e3o da qualidade, que foi igualmente auditado pela T\u00dcV S\u00dcD.<\/p><p data-start=\"1921\" data-end=\"2068\">Both milestones reinforce our commitment to quality, traceability, and continuous improvement in the development and management of medical devices.<\/p><p data-start=\"2070\" data-end=\"2295\">For WIVI, this is about more than meeting a regulatory requirement. It confirms the path we have been building for years: developing healthcare technology with the rigor needed to earn the trust of professionals and patients.<\/p><p data-start=\"2297\" data-end=\"2457\">We will continue moving forward with a clear goal: <strong data-start=\"2348\" data-end=\"2457\">raising the standard of visual health and helping improve people\u2019s quality of life through better vision.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-22fff78 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"22fff78\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-98a97cd elementor-widget elementor-widget-text-editor\" data-id=\"98a97cd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Want to learn more about WIVI technology and how it can help assess and train visual efficiency? <a href=\"https:\/\/wivivision.com\/pt\/contact-us\/\" target=\"_blank\" rel=\"noopener\"><strong>Get in touch with our team and discover WIVI.<\/strong><\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>At WIVI Vision, we are incredibly proud to have obtained Class IIa medical device certification, making WIVI one of the first vision therapy solutions in Spain to achieve this classification. This milestone represents an important step forward for WIVI and reflects our commitment to developing healthcare technology in line with the highest standards of safety, [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":8398,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[21],"tags":[],"class_list":["post-8393","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>WIVI Vision obtains Class IIa medical device certification - WIVI Vision<\/title>\n<meta name=\"description\" content=\"WIVI Vision becomes one of the first vision therapy solutions in Spain to obtain Class IIa medical device certification.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/wivivision.com\/pt\/wivi-vision-obtains-class-iia-medical-device-certification\/\" \/>\n<meta property=\"og:locale\" content=\"pt_PT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"WIVI Vision obtains Class IIa medical device certification - 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