{"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":"zugang-zum-globalen-markt-fur-medizintechnik","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/medtech-global-market-access\/","title":{"rendered":"Unterst\u00fctzung des globalen Marktzugangs f\u00fcr ein MedTech-Unternehmen"},"content":{"rendered":"<p><strong>Lesen Sie unsere Fallstudie und erfahren Sie, wie RegASK seine strategische regulatorische Expertise nutzte, um einem Medizintechnikunternehmen dabei zu helfen, die regulatorischen Anforderungen f\u00fcr den globalen Marktzugang zu erf\u00fcllen.<\/strong><\/p>\n<h2 class=\"h4\"><strong>Objektiv<\/strong><\/h2>\n<p>Ein MedTech-Startup wollte seine Software als Medizinprodukt (SaMD) auf den Markt bringen. Es wollte den optimalen Regulierungsweg f\u00fcr ANZA, die EU und die USA erfahren.<\/p>\n<h2 class=\"h4\"><strong>L\u00f6sung<\/strong><\/h2>\n<ul>\n<li>Aufbau und Unterst\u00fctzung eines Qualit\u00e4tsmanagementsystems<\/li>\n<li>Neuerstellung einer Designverlaufsdatei gem\u00e4\u00df globalen Standards<\/li>\n<li>Entwicklung einer Strategie f\u00fcr klinische Studien gem\u00e4\u00df EU- und FDA-Richtlinien<\/li>\n<\/ul>\n<h2 class=\"h4\"><strong>Ergebnisse<\/strong><\/h2>\n<p>Der Kunde erhielt strategische regulatorische Unterst\u00fctzung f\u00fcr ein konformes Qualit\u00e4tsmanagement nach internationalen Standards, was seine Marktexpansion erm\u00f6glichte.<\/p>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: center;\" data-line-height=\"xs\">Ben\u00f6tigen Sie Unterst\u00fctzung bei regulatorischen Angelegenheiten?<\/h2>\n<h2 style=\"text-align: center;\" data-line-height=\"xs\">Sprechen Sie mit unseren Experten<\/h2>\n<p style=\"text-align: center;\">Oder Sie k\u00f6nnen uns auch eine WhatsApp-Nachricht senden, indem Sie auf diese Nummer klicken\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_1666896596\">\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-1396914846\">\n\n\n\t<div id=\"col-62095978\" 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_1666896596 {\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 v27.3 (Yoast SEO v27.5) - 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\/de\/zugang-zum-globalen-markt-fur-medizintechnik\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\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\/de\/zugang-zum-globalen-markt-fur-medizintechnik\/\" \/>\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\u00a0Minute\" \/>\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\":\"de\"},{\"@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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