{"id":3882,"date":"2022-10-11T16:37:01","date_gmt":"2022-10-11T08:37:01","guid":{"rendered":"https:\/\/regask.com\/?p=3882"},"modified":"2024-11-22T05:27:28","modified_gmt":"2024-11-21T21:27:28","slug":"acceso-al-mercado-global-de-tecnologia-medica","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/medtech-global-market-access\/","title":{"rendered":"Apoyo al acceso al mercado global para una empresa de tecnolog\u00eda m\u00e9dica"},"content":{"rendered":"<p><strong>Lea nuestro estudio de caso y conozca c\u00f3mo RegASK aprovech\u00f3 su experiencia regulatoria estrat\u00e9gica para ayudar a una empresa de dispositivos m\u00e9dicos a cumplir con los requisitos regulatorios para el acceso al mercado global.<\/strong><\/p>\n<h2 class=\"h4\"><strong>Objetivo<\/strong><\/h2>\n<p>Una empresa emergente de tecnolog\u00eda m\u00e9dica quer\u00eda lanzar su software como dispositivo m\u00e9dico (SaMD). Quer\u00edan conocer la v\u00eda regulatoria \u00f3ptima para ANZA, la UE y los EE. UU.<\/p>\n<h2 class=\"h4\"><strong>Soluci\u00f3n<\/strong><\/h2>\n<ul>\n<li>Construy\u00f3 y apoy\u00f3 un Sistema de Gesti\u00f3n de Calidad<\/li>\n<li>Reconstrucci\u00f3n de un archivo de historial de dise\u00f1o de conformidad con los est\u00e1ndares globales<\/li>\n<li>Se desarroll\u00f3 una estrategia de ensayos cl\u00ednicos para las v\u00edas de la UE y la FDA.<\/li>\n<\/ul>\n<h2 class=\"h4\"><strong>Resultados<\/strong><\/h2>\n<p>El cliente recibi\u00f3 apoyo regulatorio estrat\u00e9gico para cumplir con la Gesti\u00f3n de Calidad siguiendo est\u00e1ndares internacionales, lo que le permiti\u00f3 expandirse al mercado.<\/p>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: center;\" data-line-height=\"xs\">\u00bfNecesita ayuda en asuntos regulatorios?<\/h2>\n<h2 style=\"text-align: center;\" data-line-height=\"xs\">Hable con nuestros expertos<\/h2>\n<p style=\"text-align: center;\">O tambi\u00e9n puedes enviarnos un WhatsApp haciendo clic en este n\u00famero\u00a0<a href=\"https:\/\/wa.me\/+6581282161?text=I%27m%20interested%20in%20RegASK%20solution\">+65 8128 2161<\/a><\/p>\n\n\t<section class=\"section\" id=\"section_1734934448\">\n\t\t<div class=\"section-bg fill\" >\n\t\t\t\t\t\t\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n\n<div class=\"row\"  id=\"row-620424527\">\n\n\n\t<div id=\"col-2033559522\" class=\"col medium-10 small-12 large-10\"  >\n\t\t\t\t<div class=\"col-inner text-center\"  >\n\t\t\t\n\t\t\t\n\n\n\n<script charset=\"utf-8\" type=\"text\/javascript\" src=\"\/\/js.hsforms.net\/forms\/embed\/v2.js\"><\/script>\n<script>\n  hbspt.forms.create({\n    region: \"na1\",\n    portalId: \"20908020\",\n    formId: \"0af2c091-f9d4-497e-812e-14d3abddf395\"\n  });\n<\/script>\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n<\/div>\n\n\t\t<\/div>\n\n\t\t\n<style>\n#section_1734934448 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  background-color: rgb(242,246,253);\n}\n<\/style>\n\t<\/section>","protected":false},"excerpt":{"rendered":"<p>Read our case study and learn how RegASK leveraged its strategic regulatory expertise to help a medical device company fulfill regulatory requirements for global market access. Objective A MedTech startup wanted to launch its Software As a Medical Devices (SaMD). They wanted to know the optimal regulatory pathway for ANZA, EU, and US. Solution Built&#8230;<\/p>","protected":false},"author":39,"featured_media":3880,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[17,22],"tags":[],"class_list":["post-3882","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-study","category-medical-devices"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>MedTech: Global Market Access | RegASK<\/title>\n<meta name=\"description\" content=\"RegASK supports global market access for a MedTech company. Learn how we can help you navigate regulatory challenges.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/es\/acceso-al-mercado-global-de-tecnologia-medica\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Supporting Global Market Access for a MedTech Company\" \/>\n<meta property=\"og:description\" content=\"RegASK supports global market access for a MedTech company. Learn how we can help you navigate regulatory challenges.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/acceso-al-mercado-global-de-tecnologia-medica\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2022-10-11T08:37:01+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-21T21:27:28+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2022\/10\/Supporting-Global-Market-Access-for-a-MedTech-company.png\" \/>\n\t<meta property=\"og:image:width\" content=\"331\" \/>\n\t<meta property=\"og:image:height\" content=\"301\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minuto\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/medtech-global-market-access\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/medtech-global-market-access\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"Supporting Global Market Access for a MedTech Company\",\"datePublished\":\"2022-10-11T08:37:01+00:00\",\"dateModified\":\"2024-11-21T21:27:28+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/medtech-global-market-access\\\/\"},\"wordCount\":129,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/medtech-global-market-access\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2022\\\/10\\\/Supporting-Global-Market-Access-for-a-MedTech-company.png\",\"articleSection\":[\"Case Studies\",\"Medical Devices\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/medtech-global-market-access\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/medtech-global-market-access\\\/\",\"name\":\"MedTech: Global Market Access | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/medtech-global-market-access\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/medtech-global-market-access\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2022\\\/10\\\/Supporting-Global-Market-Access-for-a-MedTech-company.png\",\"datePublished\":\"2022-10-11T08:37:01+00:00\",\"dateModified\":\"2024-11-21T21:27:28+00:00\",\"description\":\"RegASK supports global market access for a MedTech company. 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