{"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\/ca\/wivi-vision-obtains-class-iia-medical-device-certification\/","title":{"rendered":"WIVI Vision obt\u00e9 la certificaci\u00f3 de producte sanitari 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\">A WIVI Vision, estem incre\u00efblement orgullosos d'haver obtingut <strong data-start=\"119\" data-end=\"161\">Certificaci\u00f3 de producte sanitari de classe IIa<\/strong>, <strong>fent de WIVI un dels <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\">primera soluci\u00f3 de ter\u00e0pia visual<\/a> a Espanya per aconseguir aquesta classificaci\u00f3.<\/strong><\/p><p data-start=\"259\" data-end=\"465\">Aquesta fita representa un pas endavant important per a WIVI i reflecteix el nostre comprom\u00eds amb el desenvolupament de tecnologia sanit\u00e0ria d'acord amb els est\u00e0ndards m\u00e9s alts de seguretat, rendiment i evid\u00e8ncia cl\u00ednica.<\/p><p data-start=\"467\" data-end=\"717\">Fins ara, la nostra tecnologia havia estat certificada com a dispositiu m\u00e8dic de classe I. Passar a la classe IIa significa complir un marc regulador m\u00e9s exigent i superar amb \u00e8xit un proc\u00e9s d'avaluaci\u00f3 de la conformitat dut a terme per un organisme notificat independent.<\/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 marc regulador m\u00e9s exigent per a una major garantia<\/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\u00f3 de classe IIa confirma el compliment dels requisits establerts pel Reglament de Productes Sanitaris Europeu i va comportar una avaluaci\u00f3 de diferents \u00e0rees de WIVI, incloent-hi la documentaci\u00f3 t\u00e8cnica, la gesti\u00f3 de riscos i els processos implementats al llarg del cicle de vida de la soluci\u00f3.<\/p><p data-start=\"1078\" data-end=\"1363\"><strong>Per als professionals de la salut visual i els pacients, aquest proc\u00e9s proporciona una garantia addicional pel que fa a la seguretat i el rendiment de <a href=\"https:\/\/wivivision.com\/ca\/discover-wivi\/\" target=\"_blank\" rel=\"noopener\">tecnologia.<\/a><\/strong> Tamb\u00e9 refor\u00e7a la confian\u00e7a en una soluci\u00f3 dissenyada amb mecanismes per identificar, controlar i minimitzar els riscos potencials associats al seu \u00fas.<\/p><p data-start=\"1365\" data-end=\"1650\">Darrere de cada avaluaci\u00f3, cada sessi\u00f3 de ter\u00e0pia, cada mesura i cada programa desenvolupat amb WIVI hi ha un proc\u00e9s rigor\u00f3s subjecte a supervisi\u00f3 externa.<strong> Forma part del nostre comprom\u00eds de garantir que la innovaci\u00f3 en l'atenci\u00f3 sanit\u00e0ria vagi sempre acompanyada del m\u00e9s alt nivell d'est\u00e0ndards.<\/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 per a WIVI: Classe IIa i 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\">L&#x27;obtenci\u00f3 de <strong data-start=\"1730\" data-end=\"1772\">la certificaci\u00f3 de dispositiu m\u00e8dic<\/strong> de<strong data-start=\"1730\" data-end=\"1772\"> classe IIa tamb\u00e9<\/strong> coincideix amb la <strong data-start=\"1797\" data-end=\"1849\">renovaci\u00f3 de <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\">la certificaci\u00f3 ISO 13485<\/a> de WIVI Vision<\/strong> per al seu sistema de gesti\u00f3 de la qualitat, que tamb\u00e9 va ser auditada per T\u00dcV S\u00dcD.<\/p><p data-start=\"1921\" data-end=\"2068\">Ambd\u00f3s hites reforcen el nostre comprom\u00eds amb la qualitat, la tra\u00e7abilitat i la millora cont\u00ednua en el desenvolupament i la gesti\u00f3 de productes sanitaris.<\/p><p data-start=\"2070\" data-end=\"2295\">Per a WIVI, aix\u00f2 va m\u00e9s enll\u00e0 de complir amb un requisit regulador. Confirma el cam\u00ed que hem estat construint durant anys: desenvolupar tecnologia sanit\u00e0ria amb el rigor necessari per guanyar-se la confian\u00e7a de professionals i pacients.<\/p><p data-start=\"2297\" data-end=\"2457\">Seguirem avan\u00e7ant amb un objectiu clar: <strong data-start=\"2348\" data-end=\"2457\">elevar el nivell de la salut visual i ajudar a millorar la qualitat de vida de les persones a trav\u00e9s d'una millor visi\u00f3.<\/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>Voleu saber m\u00e9s sobre la tecnologia WIVI i com pot ajudar a avaluar i entrenar l'efici\u00e8ncia visual? <a href=\"https:\/\/wivivision.com\/ca\/contact-us\/\" target=\"_blank\" rel=\"noopener\"><strong>Poseu-vos en contacte amb el nostre equip i descubriu 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\/ca\/wivi-vision-obtains-class-iia-medical-device-certification\/\" \/>\n<meta property=\"og:locale\" content=\"ca_ES\" \/>\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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