{"id":10590,"date":"2025-09-19T17:09:48","date_gmt":"2025-09-19T17:09:48","guid":{"rendered":"https:\/\/mdxcro.com\/case-studies\/usability-engineering-for-home-use-ivd\/"},"modified":"2026-03-27T09:05:52","modified_gmt":"2026-03-27T09:05:52","slug":"usability-engineering-for-home-use-ivd","status":"publish","type":"case-studies","link":"https:\/\/mdxcro.com\/es\/casos-de-estudio\/usability-engineering-for-home-use-ivd\/","title":{"rendered":"Ingenier\u00eda de usabilidad para IVD de uso dom\u00e9stico"},"content":{"rendered":"\n<p><strong>Desaf\u00edo:<\/strong> Una empresa de diagn\u00f3stico que desarrollaba un novedoso ensayo de flujo lateral para uso dom\u00e9stico necesitaba una ingenier\u00eda de usabilidad integral para cumplir con los requisitos de la FDA y el IVDR para usuarios no profesionales.<\/p>\n\n<p><strong>Soluci\u00f3n:<\/strong> MDx implement\u00f3 un programa completo de ingenier\u00eda de usabilidad que inclu\u00eda:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Investigaci\u00f3n de usuarios con poblaciones de pacientes objetivo<\/li>\n\n\n\n<li>Pruebas formativas iterativas a lo largo de tres ciclos de dise\u00f1o<\/li>\n\n\n\n<li>Validaci\u00f3n exhaustiva de las instrucciones de uso y estudios de comprensi\u00f3n del etiquetado<\/li>\n\n\n\n<li>Validaci\u00f3n sumativa con 60 participantes en tres pa\u00edses<\/li>\n<\/ul>\n\n<p><strong>Resultado:<\/strong> El IVD de autodiagn\u00f3stico del cliente recibi\u00f3 tanto la autorizaci\u00f3n de la FDA como la certificaci\u00f3n IVDR sin hallazgos relacionados con la usabilidad ni cartas de deficiencia.<\/p>\n","protected":false},"featured_media":5881,"template":"","meta":{"_acf_changed":false},"class_list":["post-10590","case-studies","type-case-studies","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Ingenier\u00eda de usabilidad para IVD de uso dom\u00e9stico - MDx CRO<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mdxcro.com\/es\/casos-de-estudio\/usability-engineering-for-home-use-ivd\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Ingenier\u00eda de usabilidad para IVD de uso dom\u00e9stico - MDx CRO\" \/>\n<meta property=\"og:description\" content=\"Desaf\u00edo: Una empresa de diagn\u00f3stico que desarrollaba un novedoso ensayo de flujo lateral para uso dom\u00e9stico necesitaba una ingenier\u00eda de usabilidad integral para cumplir con los requisitos de la FDA y el IVDR para usuarios no profesionales. Soluci\u00f3n: MDx implement\u00f3 un programa completo de ingenier\u00eda de usabilidad que inclu\u00eda: Resultado: El IVD de autodiagn\u00f3stico del [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/mdxcro.com\/es\/casos-de-estudio\/usability-engineering-for-home-use-ivd\/\" \/>\n<meta property=\"og:site_name\" content=\"MDx CRO\" \/>\n<meta property=\"article:modified_time\" content=\"2026-03-27T09:05:52+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/testimonials-bg.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"1076\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 minuto\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/casos-de-estudio\\\/usability-engineering-for-home-use-ivd\\\/\",\"url\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/casos-de-estudio\\\/usability-engineering-for-home-use-ivd\\\/\",\"name\":\"Ingenier\u00eda de usabilidad para IVD de uso dom\u00e9stico - 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