{"id":4109,"date":"2023-01-31T16:13:16","date_gmt":"2023-01-31T08:13:16","guid":{"rendered":"https:\/\/regask.com\/?p=4109"},"modified":"2024-11-22T05:16:28","modified_gmt":"2024-11-21T21:16:28","slug":"lleve-su-samd-al-mercado-con-confianza-y-cumplimiento","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/bring-your-samd-to-market-with-confidence-and-compliance\/","title":{"rendered":"Llevando SaMD al mercado con confianza y cumplimiento"},"content":{"rendered":"<p>La salud digital es un campo emergente que est\u00e1 revolucionando la forma en que se brinda atenci\u00f3n m\u00e9dica. Combina tecnolog\u00eda, datos y an\u00e1lisis para mejorar los diagn\u00f3sticos, los tratamientos y los resultados de los pacientes. El software como dispositivo m\u00e9dico (SaMD), como subsector de las soluciones de salud digital, est\u00e1 experimentando un r\u00e1pido crecimiento tanto en escala industrial como en innovaciones.<\/p>\n<p>Con m\u00e1s y m\u00e1s <a href=\"https:\/\/regask.com\/es\/como-regular-los-diagnosticos-digitales-samd-en-ee-uu-y-la-ue\/\">SaMD<\/a> A medida que se implementan, las regulaciones en este campo se han vuelto cada vez m\u00e1s complejas, con m\u00e1s requisitos regulatorios y mayores variaciones entre los diferentes pa\u00edses. Lanzar un nuevo producto SaMD puede ser una tarea abrumadora. La clave para el \u00e9xito empresarial es el cumplimiento normativo. Sin embargo, con la informaci\u00f3n adecuada <a href=\"https:\/\/regask.com\/es\/como-crear-una-estrategia-regulatoria-ganadora-para-su-negocio\/\" target=\"_blank\" rel=\"noopener\">estrategia regulatoria<\/a> Una vez implementadas, las empresas pueden alinear su estrategia comercial y sus actividades regulatorias para lograr el cumplimiento del producto y el \u00e9xito en la comercializaci\u00f3n.<\/p>\n<p>Por lo tanto, es de vital importancia que los fabricantes de SaMD comprendan <a href=\"https:\/\/regask.com\/es\/when-does-your-app-become-a-medical-device\/\" target=\"_blank\" rel=\"noopener\">C\u00f3mo se regula el software como dispositivo m\u00e9dico<\/a> con el fin de desarrollar una estrategia regulatoria fuerte y eficiente.<\/p>\n<p>Aprovechando nuestra s\u00f3lida experiencia en el dominio y m\u00e1s de 20 a\u00f1os de experiencia en consultor\u00eda, RegASK tiene un historial comprobado de ayudar a los fabricantes de SaMD con sus v\u00edas regulatorias y \u00e9xito comercial.<\/p>\n<p><strong>Desde la clasificaci\u00f3n y el registro del producto hasta la comercializaci\u00f3n, lea el estudio de caso para saber c\u00f3mo RegASK ayud\u00f3 a una empresa de salud digital a construir una estrategia regulatoria \u00f3ptima en Asia.<\/strong><\/p>\n<h2 class=\"h4\"><strong>Objetivo<\/strong><\/h2>\n<p>Un proveedor l\u00edder mundial de atenci\u00f3n de salud mental digital ha desarrollado una aplicaci\u00f3n que ofrece terapia cognitivo-conductual (TCC) a pacientes con una variedad de trastornos. El cliente desea lanzar la aplicaci\u00f3n en algunos pa\u00edses asi\u00e1ticos, entre ellos Hong Kong, Malasia y Tailandia.<\/p>\n<p>El cliente quer\u00eda saber si pod\u00eda comercializar su aplicaci\u00f3n y si exist\u00eda alguna restricci\u00f3n asociada a ella en los mercados de destino. Para lograr su objetivo, el cliente contrat\u00f3 a RegASK para su <a href=\"https:\/\/regask.com\/es\/our-solution\/#monitor\" target=\"_blank\" rel=\"noopener\">servicio de consultor\u00eda en asuntos regulatorios<\/a>.<\/p>\n<h2 class=\"h4\"><strong>Soluci\u00f3n<\/strong><\/h2>\n<ul>\n<li>Identific\u00f3 el marco regulatorio aplicable del SaMD en Hong Kong, Malasia y Tailandia;<\/li>\n<li>Se definieron qu\u00e9 pa\u00edses requieren el registro del producto del cliente y el proceso de registro;<\/li>\n<li>Analiz\u00f3 si el producto debe clasificarse como dispositivo m\u00e9dico bajo la normativa existente;<\/li>\n<li>Evalu\u00f3 las posibilidades de lanzar el software del cliente en los mercados objetivo y comercializarlo bajo el modelo preferido del cliente.<\/li>\n<\/ul>\n<h2 class=\"h4\"><strong>Resultados<\/strong><\/h2>\n<p>Con la experiencia de RegASK, el cliente recibi\u00f3 informaci\u00f3n cr\u00edtica para determinar la v\u00eda regulatoria m\u00e1s apropiada para lanzar su producto SaMD en los mercados objetivo.<\/p>\n<p>La revisi\u00f3n y evaluaci\u00f3n regulatoria realizada por RegASK ayud\u00f3 al cliente a ahorrar cientos de horas buscando regulaciones y a dise\u00f1ar una estrategia regulatoria \u00f3ptima para maximizar sus posibilidades de \u00e9xito.<\/p>\n<a data-animate=\"fadeInUp\" href=\"https:\/\/regask.com\/es\/estudios-de-caso\/recursos-casos-de-estudio-dispositivos-medicos\/\" target=\"_blank\" class=\"button secondary\" rel=\"noopener\" >\n\t\t<span>Lea m\u00e1s estudios de casos sobre dispositivos m\u00e9dicos<\/span>\n\t<\/a>","protected":false},"excerpt":{"rendered":"<p>Digital health is an emerging field that is revolutionizing the way healthcare is delivered. It combines technology, data, and analytics to improve diagnoses, treatment, and patient outcomes. Software-as-a-Medical-Device (SaMD), as a subsector of digital health solutions, is experiencing fast growth in both industry scale and innovations. With more and more SaMD being rolled out, regulations&#8230;<\/p>","protected":false},"author":39,"featured_media":4108,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[17,22,535],"tags":[],"class_list":["post-4109","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-study","category-medical-devices","category-thailand-regulations"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Bringing SaMD to Market with Confidence and Compliance | RegASK<\/title>\n<meta name=\"description\" content=\"Read the case study to know how RegASK assisted a digital health company to launch their SaMD product to several markets.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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