{"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\/es\/wivi-vision-obtains-class-iia-medical-device-certification\/","title":{"rendered":"WIVI Vision, entre las primeras soluciones de terapia visual certificadas como producto sanitario de Clase 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\">En WIVI Vision estamos muy orgullosos de haber obtenido <strong data-start=\"119\" data-end=\"161\">la certificaci\u00f3n como producto sanitario de Clase IIa<\/strong>, <strong>situ\u00e1ndonos entre las primeras <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\">primeras soluciones de terapia visual<\/a> en Espa\u00f1a en alcanzar esta clasificaci\u00f3n.<\/strong><\/p><p data-start=\"259\" data-end=\"465\">Este hito supone un paso importante para WIVI y refleja nuestro compromiso con el desarrollo de tecnolog\u00eda sanitaria bajo los m\u00e1s altos est\u00e1ndares de seguridad, funcionamiento y evidencia cl\u00ednica.<\/p><p data-start=\"467\" data-end=\"717\">Hasta ahora, nuestra tecnolog\u00eda estaba certificada como producto sanitario de Clase I. El paso a Clase IIa implica adaptarse a un marco regulatorio m\u00e1s exigente y superar un proceso de evaluaci\u00f3n de conformidad realizado por un organismo notificado independiente.<\/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\">Un marco regulatorio m\u00e1s exigente para una mayor garant\u00eda<\/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\">La certificaci\u00f3n de Clase IIa acredita el cumplimiento de los requisitos establecidos por el Reglamento Europeo de Productos Sanitarios y ha requerido una evaluaci\u00f3n de diferentes \u00e1reas vinculadas a WIVI, incluyendo la documentaci\u00f3n t\u00e9cnica, la gesti\u00f3n de riesgos y los procesos implantados durante todo el ciclo de vida de la soluci\u00f3n.<\/p><p data-start=\"1078\" data-end=\"1363\"><strong>Para los profesionales de la salud visual y los pacientes, este proceso supone una garant\u00eda adicional sobre la seguridad y el funcionamiento de la <a href=\"https:\/\/wivivision.com\/es\/discover-wivi\/\" target=\"_blank\" rel=\"noopener\">tecnolog\u00eda.<\/a><\/strong> Tambi\u00e9n refuerza la confianza en una soluci\u00f3n que cuenta con mecanismos para identificar, controlar y minimizar los posibles riesgos asociados a su utilizaci\u00f3n<\/p><p data-start=\"1365\" data-end=\"1650\">Detr\u00e1s de cada evaluaci\u00f3n, cada terapia, cada medida y cada programa desarrollado con WIVI existe un proceso riguroso y sometido a supervisi\u00f3n externa.<strong> Una forma de trabajar que busca que la innovaci\u00f3n en salud siempre vaya acompa\u00f1ada del m\u00e1ximo nivel de exigencia<\/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\">Un doble aval para WIVI: Clase IIa e 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\">La obtenci\u00f3n de  <strong data-start=\"1730\" data-end=\"1772\">   la certificaci\u00f3n como producto sanitario de Clase IIa  <\/strong> coincide adem\u00e1s con la  <strong data-start=\"1797\" data-end=\"1849\"> renovaci\u00f3n de la certificaci\u00f3n <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\">ISO 13485 <\/a><\/strong> del sistema de gesti\u00f3n de calidad de WIVI Vision.<\/p><p data-start=\"1921\" data-end=\"2068\">Ambos hitos refuerzan nuestro compromiso con la calidad, la trazabilidad y la mejora continua en el desarrollo y gesti\u00f3n de productos sanitarios.<\/p><p data-start=\"2070\" data-end=\"2295\">Para WIVI, no se trata \u00fanicamente de cumplir con un requisito regulatorio. Es la confirmaci\u00f3n del camino que llevamos a\u00f1os construyendo: desarrollar tecnolog\u00eda sanitaria con rigor para que profesionales y pacientes puedan confiar en ella.<\/p><p data-start=\"2297\" data-end=\"2457\">Seguimos avanzando con un objetivo claro: <strong data-start=\"2348\" data-end=\"2457\">elevar el est\u00e1ndar de la salud visual y contribuir a mejorar la calidad de vida de las personas a trav\u00e9s de la visi\u00f3n.<\/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>\u00bfQuieres conocer m\u00e1s sobre la tecnolog\u00eda WIVI y c\u00f3mo puede ayudarte a evaluar y entrenar la eficiencia visual? <a href=\"https:\/\/wivivision.com\/es\/contact-us\/\" target=\"_blank\" rel=\"noopener\"><strong>Ponte en contacto con nuestro equipo y descubre 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\/es\/wivi-vision-obtains-class-iia-medical-device-certification\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"WIVI Vision obtains Class IIa medical device certification - WIVI Vision\" \/>\n<meta property=\"og:description\" content=\"WIVI Vision becomes one of the first vision therapy solutions in Spain to obtain Class IIa medical device certification.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/wivivision.com\/es\/wivi-vision-obtains-class-iia-medical-device-certification\/\" \/>\n<meta property=\"og:site_name\" content=\"WIVI Vision\" \/>\n<meta property=\"article:published_time\" content=\"2026-08-12T07:30:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-08-12T07:30:01+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/wivivision.com\/wp-content\/uploads\/2026\/08\/Imagenes-web-.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"1080\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Mar\u00eda\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Mar\u00eda\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/wivivision.com\\\/wivi-vision-obtains-class-iia-medical-device-certification\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/wivivision.com\\\/wivi-vision-obtains-class-iia-medical-device-certification\\\/\"},\"author\":{\"name\":\"Mar\u00eda\",\"@id\":\"https:\\\/\\\/wivivision.com\\\/#\\\/schema\\\/person\\\/a989236b0391ff022065de3dd5cc88dc\"},\"headline\":\"WIVI Vision obtains Class IIa medical device certification\",\"datePublished\":\"2026-08-12T07:30:00+00:00\",\"dateModified\":\"2026-08-12T07:30:01+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/wivivision.com\\\/wivi-vision-obtains-class-iia-medical-device-certification\\\/\"},\"wordCount\":383,\"publisher\":{\"@id\":\"https:\\\/\\\/wivivision.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/wivivision.com\\\/wivi-vision-obtains-class-iia-medical-device-certification\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/wivivision.com\\\/wp-content\\\/uploads\\\/2026\\\/08\\\/Imagenes-web-.png\",\"articleSection\":[\"News\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/wivivision.com\\\/wivi-vision-obtains-class-iia-medical-device-certification\\\/\",\"url\":\"https:\\\/\\\/wivivision.com\\\/wivi-vision-obtains-class-iia-medical-device-certification\\\/\",\"name\":\"WIVI Vision obtains Class IIa medical device certification - 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