{"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\">Na WIVI Vision, estamos incrivelmente orgulhosos por ter obtido <strong data-start=\"119\" data-end=\"161\">certifica\u00e7\u00e3o de dispositivo m\u00e9dico de Classe IIa<\/strong>, <strong>tornando o WIVI num dos <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\">solu\u00e7\u00f5es de terapia visual prim\u00e1ria<\/a> em Espanha para alcan\u00e7ar esta classifica\u00e7\u00e3o.<\/strong><\/p><p data-start=\"259\" data-end=\"465\">Este marco representa um passo importante em frente para a WIVI e reflete o nosso compromisso com o desenvolvimento de tecnologia de sa\u00fade em conson\u00e2ncia com os mais elevados padr\u00f5es de seguran\u00e7a, desempenho e evid\u00eancia cl\u00ednica.<\/p><p data-start=\"467\" data-end=\"717\">At\u00e9 agora, a nossa tecnologia tinha sido certificada como um dispositivo m\u00e9dico de Classe I. A transi\u00e7\u00e3o para a Classe IIa significa cumprir um enquadramento regulamentar mais exigente e concluir com sucesso um processo de avalia\u00e7\u00e3o de conformidade realizado por um organismo notificado independente.<\/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\">Um enquadramento regulat\u00f3rio mais exigente para uma maior 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\">A certifica\u00e7\u00e3o de Classe IIa confirma a conformidade com os requisitos estabelecidos pelo Regulamento de Dispositivos M\u00e9dicos da Europa e envolveu uma avalia\u00e7\u00e3o de diferentes \u00e1reas da WIVI, incluindo a documenta\u00e7\u00e3o t\u00e9cnica, a gest\u00e3o de risco e os processos implementados ao longo do ciclo de vida da solu\u00e7\u00e3o.<\/p><p data-start=\"1078\" data-end=\"1363\"><strong>Para os profissionais de sa\u00fade ocular e para os doentes, este processo proporciona garantias adicionais relativamente \u00e0 seguran\u00e7a e ao desempenho do\/da <a href=\"https:\/\/wivivision.com\/pt\/discover-wivi\/\" target=\"_blank\" rel=\"noopener\">tecnologia.<\/a><\/strong> Tamb\u00e9m refor\u00e7a a confian\u00e7a numa solu\u00e7\u00e3o concebida com mecanismos para identificar, controlar e minimizar potenciais riscos associados \u00e0 sua utiliza\u00e7\u00e3o.<\/p><p data-start=\"1365\" data-end=\"1650\">Por tr\u00e1s de cada avalia\u00e7\u00e3o, de cada sess\u00e3o terap\u00eautica, de cada medi\u00e7\u00e3o e de cada programa desenvolvido com o WIVI h\u00e1 um processo rigoroso sujeito a supervis\u00e3o externa.<strong> Faz parte do nosso compromisso garantir que a inova\u00e7\u00e3o nos cuidados de sa\u00fade seja sempre acompanhada pelo mais alto n\u00edvel de padr\u00f5es.<\/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\">Uma dupla certifica\u00e7\u00e3o para a WIVI: Classe 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\">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\">Ambos os marcos refor\u00e7am o nosso compromisso com a qualidade, a rastreabilidade e a melhoria cont\u00ednua no desenvolvimento e gest\u00e3o de dispositivos m\u00e9dicos.<\/p><p data-start=\"2070\" data-end=\"2295\">Para a WIVI, trata-se de muito mais do que cumprir um requisito regulamentar. Confirma o caminho que temos vindo a construir h\u00e1 anos: desenvolver tecnologia de sa\u00fade com o rigor necess\u00e1rio para conquistar a confian\u00e7a de profissionais e doentes.<\/p><p data-start=\"2297\" data-end=\"2457\">Vamos continuar a avan\u00e7ar com um objetivo claro: <strong data-start=\"2348\" data-end=\"2457\">elevar o padr\u00e3o da sa\u00fade visual e ajudar a melhorar a qualidade de vida das pessoas atrav\u00e9s de uma melhor vis\u00e3o.<\/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>Quer saber mais sobre a tecnologia WIVI e como esta pode ajudar a avaliar e treinar a efici\u00eancia visual? <a href=\"https:\/\/wivivision.com\/pt\/contact-us\/\" target=\"_blank\" rel=\"noopener\"><strong>Entre em contacto com a nossa equipa e descubra a 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 v28.3 - 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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