{"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\/de\/wivi-vision-obtains-class-iia-medical-device-certification\/","title":{"rendered":"WIVI Vision erh\u00e4lt die Zertifizierung als Medizinprodukt der Klasse 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\">Bei WIVI Vision sind wir unglaublich stolz darauf, erhalten zu haben <strong data-start=\"119\" data-end=\"161\">Zertifizierung als Medizinprodukt der Klasse IIa<\/strong>, <strong>WIVI zu einem der <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\">erste L\u00f6sungen f\u00fcr die Sehtherapie<\/a> in Spanien, um diese Klassifizierung zu erreichen.<\/strong><\/p><p data-start=\"259\" data-end=\"465\">Dieser Meilenstein stellt einen wichtigen Schritt nach vorn f\u00fcr WIVI dar und spiegelt unser Engagement wider, Medizintechnik im Einklang mit den h\u00f6chsten Standards hinsichtlich Sicherheit, Leistung und klinischer Evidenz zu entwickeln.<\/p><p data-start=\"467\" data-end=\"717\">Bisher war unsere Technologie als Medizinprodukt der Klasse I zertifiziert. Der \u00dcbergang zur Klasse IIa bedeutet, dass strengere regulatorische Anforderungen erf\u00fcllt und ein von einer unabh\u00e4ngigen benannten Stelle durchgef\u00fchrtes Konformit\u00e4tsbewertungsverfahren erfolgreich abgeschlossen werden muss.<\/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\">Ein strengeres regulatorisches Rahmenwerk f\u00fcr mehr Sicherheit<\/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\">Die Zertifizierung der Klasse IIa best\u00e4tigt die Einhaltung der Anforderungen der europ\u00e4ischen Medizinprodukteverordnung und umfasste eine Bewertung verschiedener Bereiche von WIVI, einschlie\u00dflich der technischen Dokumentation, des Risikomanagements und der w\u00e4hrend des gesamten Lebenszyklus der L\u00f6sung implementierten Prozesse.<\/p><p data-start=\"1078\" data-end=\"1363\"><strong>F\u00fcr Augen\u00e4rzte und Patienten bietet dieser Prozess zus\u00e4tzliche Sicherheit hinsichtlich der Sicherheit und Leistung des <a href=\"https:\/\/wivivision.com\/de\/discover-wivi\/\" target=\"_blank\" rel=\"noopener\">Technologie.<\/a><\/strong> Es st\u00e4rkt auch das Vertrauen in eine L\u00f6sung, die mit Mechanismen zur Identifizierung, Kontrolle und Minimierung potenzieller Risiken bei ihrer Anwendung konzipiert wurde.<\/p><p data-start=\"1365\" data-end=\"1650\">Hinter jeder Beurteilung, jeder Therapiesitzung, jeder Messung und jedem mit WIVI entwickelten Programm steht ein strenger Prozess, der einer externen Kontrolle unterliegt.<strong> Es ist Teil unseres Engagements, sicherzustellen, dass Innovationen im Gesundheitswesen stets von h\u00f6chstem Niveau begleitet werden.<\/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\">Doppelte Zertifizierung f\u00fcr WIVI: Klasse IIa und 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\">Die Erlangung der     <strong data-start=\"1730\" data-end=\"1772\">Zertifizierung als Medizinprodukt<\/strong> der<strong data-start=\"1730\" data-end=\"1772\"> Klasse IIa<\/strong>    f\u00e4llt <strong data-start=\"1730\" data-end=\"1772\">zudem<\/strong> mit der <strong data-start=\"1797\" data-end=\"1849\">Erneuerung der <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-Zertifizierung<\/a><\/strong> f\u00fcr das Qualit\u00e4tsmanagementsystem <strong data-start=\"1797\" data-end=\"1849\">von WIVI Vision<\/strong> zusammen, das ebenfalls vom T\u00dcV S\u00dcD auditiert wurde.<\/p><p data-start=\"1921\" data-end=\"2068\">Beide Meilensteine untermauern unser Engagement f\u00fcr Qualit\u00e4t, R\u00fcckverfolgbarkeit und kontinuierliche Verbesserung bei der Entwicklung und dem Management von Medizinprodukten.<\/p><p data-start=\"2070\" data-end=\"2295\">F\u00fcr WIVI geht es hier um mehr als nur um die Erf\u00fcllung einer regulatorischen Anforderung. Es best\u00e4tigt den Weg, den wir seit Jahren beschreiten: die Entwicklung von Gesundheitstechnologie mit der erforderlichen Sorgfalt, um das Vertrauen von Fachleuten und Patienten zu gewinnen.<\/p><p data-start=\"2297\" data-end=\"2457\">Wir werden mit einem klaren Ziel weiter voranschreiten: <strong data-start=\"2348\" data-end=\"2457\">Anhebung des Standards der visuellen Gesundheit und Unterst\u00fctzung zur Verbesserung der Lebensqualit\u00e4t der Menschen durch besseres Sehen.<\/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>M\u00f6chten Sie mehr \u00fcber die WIVI-Technologie erfahren und wie sie bei der Beurteilung und dem Training der Seheffizienz helfen kann? <a href=\"https:\/\/wivivision.com\/de\/contact-us\/\" target=\"_blank\" rel=\"noopener\"><strong>Setzen Sie sich mit unserem Team in Verbindung und entdecken Sie 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\/de\/wivi-vision-obtains-class-iia-medical-device-certification\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\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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