{"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":"bringen-sie-ihr-samsung-mit-vertrauen-und-compliance-auf-den-markt","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/bring-your-samd-to-market-with-confidence-and-compliance\/","title":{"rendered":"SaMD mit Vertrauen und Compliance auf den Markt bringen"},"content":{"rendered":"<p>Digital Health ist ein aufstrebendes Feld, das die Gesundheitsversorgung revolutioniert. Es kombiniert Technologie, Daten und Analysen, um Diagnose, Behandlung und Patientenergebnisse zu verbessern. Software-as-a-Medical-Device (SaMD), ein Teilbereich digitaler Gesundheitsl\u00f6sungen, verzeichnet ein rasantes Wachstum sowohl in der Branche als auch bei Innovationen.<\/p>\n<p>Mit immer mehr <a href=\"https:\/\/regask.com\/de\/how-to-regulate-samd-digital-diagnostics-us-eu\/\">SaMD<\/a> Die Vorschriften in diesem Bereich sind zunehmend komplexer geworden, mit zunehmenden regulatorischen Anforderungen und gr\u00f6\u00dferen Unterschieden zwischen den L\u00e4ndern. Die Einf\u00fchrung eines neuen SaMD-Produkts kann eine gewaltige Aufgabe sein. Der Schl\u00fcssel zum Gesch\u00e4ftserfolg liegt in der Einhaltung der Vorschriften. Mit der richtigen <a href=\"https:\/\/regask.com\/de\/how-to-create-a-winning-regulatory-strategy-for-your-business\/\" target=\"_blank\" rel=\"noopener\">Regulierungsstrategie<\/a> Mithilfe dieser Ma\u00dfnahmen k\u00f6nnen Unternehmen ihre Gesch\u00e4ftsstrategie und ihre regulatorischen Aktivit\u00e4ten aufeinander abstimmen, um Produktkonformit\u00e4t und Markteinf\u00fchrungserfolge zu erzielen.<\/p>\n<p>Daher ist es f\u00fcr SaMD-Hersteller von entscheidender Bedeutung zu verstehen <a href=\"https:\/\/regask.com\/de\/when-does-your-app-become-a-medical-device\/\" target=\"_blank\" rel=\"noopener\">wie Software als Medizinprodukt reguliert wird<\/a> um eine starke und effiziente Regulierungsstrategie zu entwickeln.<\/p>\n<p>RegASK nutzt seine umfassende Fachkompetenz und \u00fcber 20 Jahre Beratungserfahrung und verf\u00fcgt \u00fcber eine nachgewiesene Erfolgsbilanz bei der Unterst\u00fctzung von SaMD-Herstellern bei ihren regulatorischen Schritten und ihrem kommerziellen Erfolg.<\/p>\n<p><strong>Von der Produktklassifizierung und -registrierung bis hin zur Vermarktung: Lesen Sie die Fallstudie, um zu erfahren, wie RegASK einem digitalen Gesundheitsunternehmen dabei geholfen hat, eine optimale Regulierungsstrategie in Asien zu entwickeln.<\/strong><\/p>\n<h2 class=\"h4\"><strong>Objektiv<\/strong><\/h2>\n<p>Ein weltweit f\u00fchrender Anbieter digitaler psychiatrischer Versorgung hat eine App entwickelt, die Patienten mit verschiedenen St\u00f6rungen kognitive Verhaltenstherapie (KVT) erm\u00f6glicht. Der Kunde m\u00f6chte die App in einigen asiatischen L\u00e4ndern, darunter Hongkong, Malaysia und Thailand, einf\u00fchren.<\/p>\n<p>Der Kunde wollte wissen, ob seine App kommerzialisiert werden kann und ob es in den Zielm\u00e4rkten Einschr\u00e4nkungen gibt. Um dieses Ziel zu erreichen, beauftragte der Kunde RegASK mit der <a href=\"https:\/\/regask.com\/de\/our-solution\/#monitor\" target=\"_blank\" rel=\"noopener\">Beratungsservice f\u00fcr regulatorische Angelegenheiten<\/a>.<\/p>\n<h2 class=\"h4\"><strong>L\u00f6sung<\/strong><\/h2>\n<ul>\n<li>Ermittlung des geltenden Regulierungsrahmens f\u00fcr SaMD in Hongkong, Malaysia und Thailand;<\/li>\n<li>Definiert, welche L\u00e4nder eine Registrierung des Produkts des Kunden erfordern und wie der Registrierungsprozess abl\u00e4uft;<\/li>\n<li>Analysiert, ob das Produkt gem\u00e4\u00df den geltenden Vorschriften als Medizinprodukt eingestuft werden sollte;<\/li>\n<li>Bewertete die M\u00f6glichkeiten, die Software des Kunden in Zielm\u00e4rkten einzuf\u00fchren und sie nach dem bevorzugten Modell des Kunden zu vermarkten.<\/li>\n<\/ul>\n<h2 class=\"h4\"><strong>Ergebnisse<\/strong><\/h2>\n<p>Dank der Fachkompetenz von RegASK erhielt der Kunde wichtige Informationen, um den geeignetsten regulatorischen Weg f\u00fcr die Markteinf\u00fchrung seines SaMD-Produkts in den Zielm\u00e4rkten zu bestimmen.<\/p>\n<p>Durch die von RegASK durchgef\u00fchrte regulatorische \u00dcbersicht und Bewertung konnte der Kunde Hunderte von Stunden bei der Suche nach Vorschriften einsparen und eine optimale Regulierungsstrategie entwickeln, um seine Erfolgschancen zu maximieren.<\/p>\n<a data-animate=\"fadeInUp\" href=\"https:\/\/regask.com\/de\/fallstudien\/ressourcen-fallstudien-medizinprodukte\/\" target=\"_blank\" class=\"button secondary\" rel=\"noopener\" >\n\t\t<span>Lesen Sie weitere Fallstudien zu Medizinprodukten<\/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 v28.0 (Yoast SEO v28.1) - 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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