{"id":10585,"date":"2025-09-19T11:46:32","date_gmt":"2025-09-19T11:46:32","guid":{"rendered":"https:\/\/mdxcro.com\/case-studies\/mobile-health-application-with-mdr-compliance\/"},"modified":"2026-03-27T09:04:30","modified_gmt":"2026-03-27T09:04:30","slug":"mobile-health-application-with-mdr-compliance","status":"publish","type":"case-studies","link":"https:\/\/mdxcro.com\/es\/casos-de-estudio\/mobile-health-application-with-mdr-compliance\/","title":{"rendered":"Aplicaci\u00f3n de salud m\u00f3vil con conformidad con el MDR"},"content":{"rendered":"\n<section id=\"block_51ef5d1efd54e45582b00db2bd8f8677\" class=\"text-image text-image--text-only text-image--wide\" style=\"\">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Aplicaci\u00f3n de salud m\u00f3vil con conformidad con el MDR<\/h2><div class=\"description wysiwyg\"><p><!-- wp:paragraph --><strong>Desaf\u00edo:<\/strong> Una startup desarroll\u00f3 una aplicaci\u00f3n m\u00f3vil para la adherencia al tratamiento que calificaba como producto sanitario de Clase IIa seg\u00fan el MDR, pero carec\u00eda de la experiencia regulatoria interna para gestionar los requisitos de software.<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><strong>Soluci\u00f3n:<\/strong> MDx proporcion\u00f3:<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:list --><\/p>\n<ul class=\"wp-block-list\">\n<li style=\"list-style-type: none\">\n<ul class=\"wp-block-list\"><!-- wp:list-item --><\/p>\n<li>Implementaci\u00f3n y documentaci\u00f3n completa de la norma IEC 62304<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><!-- \/wp:list-item --> <!-- wp:list-item --><\/p>\n<ul class=\"wp-block-list\">\n<li style=\"list-style-type: none\">\n<ul class=\"wp-block-list\">\n<li>Evaluaci\u00f3n de riesgos de ciberseguridad y documentaci\u00f3n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><!-- \/wp:list-item --> <!-- wp:list-item --><\/p>\n<ul class=\"wp-block-list\">\n<li style=\"list-style-type: none\">\n<ul class=\"wp-block-list\">\n<li>Proceso de ingenier\u00eda de usabilidad alineado con la norma IEC 62366<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><!-- \/wp:list-item --> <!-- wp:list-item --><\/p>\n<ul class=\"wp-block-list\">\n<li style=\"list-style-type: none\">\n<ul class=\"wp-block-list\">\n<li>Estrategia de evaluaci\u00f3n cl\u00ednica basada en la recopilaci\u00f3n de evidencias del mundo real<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><!-- \/wp:list-item --><\/p>\n<p><!-- \/wp:list --><\/p>\n<p><!-- wp:paragraph --><strong>Resultado:<\/strong> Obtenci\u00f3n del marcado CE en 11 meses, lo que permiti\u00f3 al cliente lanzarse al mercado europeo antes que sus competidores.<\/p>\n<!-- \/wp:paragraph --><\/div><\/div><\/div>                    <\/div>\n    <\/div>\n<\/section>\n","protected":false},"featured_media":6865,"template":"","meta":{"_acf_changed":false},"class_list":["post-10585","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 - 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