{"id":4809,"date":"2025-06-01T10:00:00","date_gmt":"2025-06-01T13:00:00","guid":{"rendered":"https:\/\/sobelconsult.com\/unterstuetzung-bei-regulatorischen-angelegenheiten-usa\/"},"modified":"2026-02-02T15:12:01","modified_gmt":"2026-02-02T18:12:01","slug":"fda-medical-device-regulatory-consulting","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/de\/our-solutions-usa\/fda-medical-device-regulatory-consulting\/","title":{"rendered":"Unterst\u00fctzung bei regulatorischen Angelegenheiten - USA"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"4809\" class=\"elementor elementor-4809 elementor-1765\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2c8e4a5 e-flex e-con-boxed e-con e-parent\" data-id=\"2c8e4a5\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3fe8293 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"3fe8293\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">FDA Beratung f\u00fcr Medizinprodukte und Regulierung<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8d4d993 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"8d4d993\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Entering the U.S. medical device market requires precision, strategy, and full alignment with FDA expectations. From classification to submission, Sobel supports manufacturers at every stage of the FDA process \u2014 transforming complex requirements into a clear, efficient, and compliant pathway to approval.\"}]\" data-inline-monday=\"true\">Der Eintritt in den US-amerikanischen Markt f\u00fcr Medizinprodukte erfordert Pr\u00e4zision, Strategie und eine vollst\u00e4ndige Anpassung an die Erwartungen der FDA. Von der Klassifizierung bis zur Einreichung unterst\u00fctzt Sobel die Hersteller in jeder Phase des FDA-Prozesses und verwandelt die komplexen Anforderungen in einen klaren, effizienten und konformen Weg zur Zulassung. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3915b31 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"3915b31\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6NzM0MywidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Holen Sie sich Expertenunterst\u00fctzung<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f19cf34 e-flex e-con-boxed e-con e-parent\" data-id=\"f19cf34\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-ce217ea e-con-full e-flex e-con e-child\" data-id=\"ce217ea\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-5fef94c e-con-full e-transform e-flex e-con e-child\" data-id=\"5fef94c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation_mobile&quot;:&quot;fadeIn&quot;,&quot;_transform_translateX_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:96,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:-109,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4f6c1db elementor-widget elementor-widget-heading\" data-id=\"4f6c1db\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\">F\u00fcr wen?<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-506ff08 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"506ff08\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-280d786 elementor-align-end elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"280d786\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Unternehmen, die FDA-Antr\u00e4ge vorbereiten, aktualisieren oder \u00fcberpr\u00fcfen (510(k), PMA, De Novo, 513(g) usw.)<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Internationale Hersteller dr\u00e4ngen auf den US-Markt.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">RA\/QA-Teams, die strukturierte, fortlaufende regulatorische Unterst\u00fctzung ben\u00f6tigen<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Startups suchen Klarheit \u00fcber Ger\u00e4teklassifizierung und regulatorische Verpflichtungen<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Unternehmen, die eine fachkundige Beratung bei der Einhaltung von Vorschriften, Einreichungen und Erwartungen nach der Markteinf\u00fchrung von Medizinprodukten ben\u00f6tigen<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-b3f5459 e-con-full e-flex e-con e-child\" data-id=\"b3f5459\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation_mobile&quot;:&quot;fadeIn&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2aefb96 elementor-widget elementor-widget-image\" data-id=\"2aefb96\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"755\" height=\"1024\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-755x1024.png\" class=\"attachment-large size-large wp-image-18565\" alt=\"A portable vital signs monitor sits on a table. Office supplies are also on the table. It looks like a doctor&#039;s office.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-755x1024.png 755w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-221x300.png 221w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-768x1041.png 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services.png 1011w\" sizes=\"(max-width: 755px) 100vw, 755px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e53fc74 e-flex e-con-boxed e-con e-parent\" data-id=\"e53fc74\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-884d760 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"884d760\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"With deep experience in FDA processes and global regulatory frameworks, Sobel provides the level of technical and strategic support that companies need to access the U.S. market successfully. \"}]\" data-inline-monday=\"true\">Mit seiner umfassenden Erfahrung in den Prozessen der FDA und den globalen regulatorischen Rahmenbedingungen bietet Sobel das Ma\u00df an technischer und strategischer Unterst\u00fctzung, das Unternehmen f\u00fcr einen erfolgreichen Zugang zum US-Markt ben\u00f6tigen.  <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-77a6363 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"77a6363\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6NzM0MywidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Holen Sie sich Unterst\u00fctzung!<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6a1bbcf e-flex e-con-boxed e-con e-parent\" data-id=\"6a1bbcf\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b771077 elementor-widget-mobile__width-inherit elementor-widget elementor-widget-image\" data-id=\"b771077\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1259\" height=\"275\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue.png\" class=\"attachment-full size-full wp-image-18571\" alt=\"Vector rectangle blue\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue.png 1259w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue-300x66.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue-1024x224.png 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue-768x168.png 768w\" sizes=\"(max-width: 1259px) 100vw, 1259px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c9914c2 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"c9914c2\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Warum brauchen Sie diesen Service?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d7a5d75 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"d7a5d75\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-e64a01f e-con-full e-flex e-con e-child\" data-id=\"e64a01f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ee20a3b elementor-widget elementor-widget-text-editor\" data-id=\"ee20a3b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"FDA compliance is a legal requirement, and misunderstanding these obligations can lead to project stoppages, rejections, or enforcement actions.\"}]\" data-inline-monday=\"true\">Die Einhaltung der FDA-Vorschriften ist gesetzlich vorgeschrieben, und ein Missverst\u00e4ndnis dieser Verpflichtungen kann zu Projektstopps, Ablehnungen oder Durchsetzungsma\u00dfnahmen f\u00fchren.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1f8f9a2 e-con-full e-flex e-con e-child\" data-id=\"1f8f9a2\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2f5373b elementor-widget elementor-widget-text-editor\" data-id=\"2f5373b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Specialized regulatory guidance helps you prepare submissions and documentation that meet FDA expectations without unnecessary rework or delays.\"}]\" data-inline-monday=\"true\">Spezialisierte Anleitungen helfen Ihnen bei der Vorbereitung von Antr\u00e4gen und Dokumentationen, die den Erwartungen der FDA entsprechen, ohne unn\u00f6tige Nacharbeiten oder Verz\u00f6gerungen.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4ac5acf e-con-full e-flex e-con e-child\" data-id=\"4ac5acf\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9c5d53f elementor-widget elementor-widget-text-editor\" data-id=\"9c5d53f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"With expert support, your team strengthens decision-making, reduces regulatory risk, and moves through each FDA step with greater clarity and confidence.\"}]\" data-inline-monday=\"true\">Mit der Unterst\u00fctzung von Experten st\u00e4rkt Ihr Team die Entscheidungsfindung, reduziert das regulatorische Risiko und durchl\u00e4uft jeden FDA-Schritt mit gr\u00f6\u00dferer Klarheit und Zuversicht.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5f1b766 e-flex e-con-boxed e-con e-parent\" data-id=\"5f1b766\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-fd2938a e-con-full e-flex e-con e-child\" data-id=\"fd2938a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-20ce0b0 elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"20ce0b0\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Beratung bei der Zulassung von Medizinprodukten f\u00fcr einen sicheren FDA-Einreichungsprozess<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7af3814 e-con-full e-flex e-con e-child\" data-id=\"7af3814\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e6b60d7 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"e6b60d7\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Our approach blends technical expertise with practical execution, guiding your company through every regulatory decision. \"}]\" data-inline-monday=\"true\">Unser Ansatz verbindet technisches Fachwissen mit praktischer Umsetzung und begleitet Ihr Unternehmen bei allen regulatorischen Entscheidungen.  <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9f7dd57 e-flex e-con-boxed e-con e-parent\" data-id=\"9f7dd57\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c78d253 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"c78d253\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Sobel bietet einen kompletten Beratungsrahmen f\u00fcr Medizinprodukte, der auf Ihre Produkt- und Marktziele zugeschnitten ist.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2c226ee elementor-widget elementor-widget-ucaddon_horizontal_timeline\" data-id=\"2c226ee\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"ucaddon_horizontal_timeline.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\n<!-- start Horizontal Timeline -->\n\t\t<link id='font-awesome-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/font-awesome6\/fontawesome-all.min.css' type='text\/css' rel='stylesheet' >\n\t\t<link id='font-awesome-4-shim-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/font-awesome6\/fontawesome-v4-shims.min.css' type='text\/css' rel='stylesheet' >\n\t\t<link id='owl-carousel-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/owl-carousel-new\/assets\/owl.carousel.css' type='text\/css' rel='stylesheet' >\n\n<style>\/* widget: Horizontal Timeline *\/\n\n#uc_horizontal_timeline_elementor_2c226ee *{\n  box-sizing:border-box;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee{\n  position:relative;\n  min-height:1px;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-carousel-content{\n    display: flex;\n    flex-flow: column nowrap;\n    flex:1;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-carousel-item{\n  overflow:hidden;\n  position:relative;\n  display:flex;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-btn-holder{\n  margin-top:auto;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-btn{\n  text-align:center;\n  text-decoration:none;\n  transition:0.3s;\n} \n\n#uc_horizontal_timeline_elementor_2c226ee .item-horizontal-timeline .ue-item-title{\n  font-size:21px;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .carousel-nav{\n  position:relative;\n  z-index:10;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .carousel-nav .carousel-prev{\n    position:absolute;\n      display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_2c226ee .carousel-nav .carousel-next{\n  position:absolute;\n  display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_2c226ee  .carousel-nav button svg, \n#uc_horizontal_timeline_elementor_2c226ee  .carousel-nav button i{\n  position: absolute;\n     top: 50%;\n  left: 50%;\n  transform: translate(-50%, -50%);\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .owl-dots {\n  overflow:hidden;\n  display:true !important;  \n}\n\n#uc_horizontal_timeline_elementor_2c226ee .owl-dot {\n  border-radius:50%;\n  display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-item-bullet-holder{\n  display:flex;\n  align-items:center;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-item-bullet-line{\n  flex-grow:1;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-item-bullet-line-spacing{\n  flex-grow:0;\n  flex-shrink:0;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-item-bullet{\n  position:relative;\n  transition: all .3s ease;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-item-bullet i, #uc_horizontal_timeline_elementor_2c226ee .ue-item-bullet svg{\n  position: absolute;\n  top: 50%;\n  left: 50%;\n  transform: translate(-50%, -50%); \n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-item-label a{\n  font-size:12px;\n  line-height:1.5em;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-item-image{\n  overflow:hidden;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-item-image a{\n  display:block;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-item-image img{\n  object-fit: cover;\n  width:100%;\n  transition:0.3s;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-item-vertical-line-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-item-pointer-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-carousel-item:hover .ue-item-image img{\n  transform:scale(1.1,1.1);\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-item-label{\n display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_2c226ee .ue-carousel-item-holder{\n  display: flex;\n  flex-direction: column;\n  align-items: stretch;\n  height:100%;\n}\n\n<\/style>\n\n<div class=\"ue-horizontal-timeline\" id=\"uc_horizontal_timeline_elementor_2c226ee\">\n     <div class=\"carousel-nav\">\n            <button class=\"carousel-prev\" aria-label=\"Previous\">\n                <i class=' ti-arrow-circle-left'><\/i>\n            <\/button>\n            <button class=\"carousel-next\" aria-label=\"Next\">\n                <i class=' ti-arrow-circle-right'><\/i>\n            <\/button>\n        <\/div>\n    <div class=\"owl-carousel owl-theme uc-items-wrapper item-horizontal-timeline  \" id=\"uc_horizontal_timeline_elementor_2c226ee\" data-custom-sethtml=\"true\"  >\n     \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-58fbbfd\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >W\u00e4hlen Sie Ihren Service<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">W\u00e4hlen Sie den FDA-Regulierungsservice, den Sie ben\u00f6tigen - und wenn Sie unsicher sind, helfen wir Ihnen, den richtigen Weg f\u00fcr Ihr Produkt zu finden.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-5ca2a2a\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Dokumentation bereitstellen<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Sobel fordert alle erforderlichen Dokumente an, damit der Regulierungsprozess effizient und ohne Verz\u00f6gerungen voranschreiten kann.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-9cdd855\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Verfolgen Sie Ihr Projekt<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Wir f\u00fchren die Arbeit aus, w\u00e4hrend Sie jeden Schritt in Echtzeit \u00fcber unsere Online-Projektplattform verfolgen.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n\n  <\/div>\n<\/div>\n<!-- end Horizontal Timeline -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5df4616 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"5df4616\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6NzM0MywidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Beginnen Sie jetzt!<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-897abdc animated-slow e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"897abdc\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c090ee2 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"c090ee2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Welcher Service gilt f\u00fcr Ihr Medizinprodukt?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ad2199c elementor-widget elementor-widget-text-editor\" data-id=\"ad2199c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"FDA regulations require a robust, evidence-based approach to safety, effectiveness, and documentation. You can choose from the following options, depending on your device\u2019s needs and stage of development:\"}]\" data-inline-monday=\"true\">Die FDA-Vorschriften verlangen einen soliden, evidenzbasierten Ansatz f\u00fcr Sicherheit, Wirksamkeit und Dokumentation. Je nach den Bed\u00fcrfnissen und dem Entwicklungsstadium Ihres Produkts k\u00f6nnen Sie aus den folgenden Optionen w\u00e4hlen: <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-18e2e92 elementor-arrows-position-outside elementor-pagination-type-bullets elementor-pagination-position-outside elementor-widget elementor-widget-n-carousel\" data-id=\"18e2e92\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;carousel_items&quot;:[{&quot;slide_title&quot;:&quot;Slide #1&quot;,&quot;_id&quot;:&quot;5e096ea&quot;},{&quot;slide_title&quot;:&quot;Slide #2&quot;,&quot;_id&quot;:&quot;6c6581a&quot;},{&quot;slide_title&quot;:&quot;Slide #3&quot;,&quot;_id&quot;:&quot;1d7e525&quot;},{&quot;_id&quot;:&quot;c8e3172&quot;,&quot;slide_title&quot;:&quot;Slide #4&quot;},{&quot;slide_title&quot;:&quot;Slide #5&quot;,&quot;_id&quot;:&quot;8e6060c&quot;},{&quot;slide_title&quot;:&quot;Slide #5&quot;,&quot;_id&quot;:&quot;a38a454&quot;},{&quot;slide_title&quot;:&quot;Slide #5&quot;,&quot;_id&quot;:&quot;3906af6&quot;},{&quot;slide_title&quot;:&quot;Slide #5&quot;,&quot;_id&quot;:&quot;2bd43f9&quot;},{&quot;slide_title&quot;:&quot;Slide #5&quot;,&quot;_id&quot;:&quot;24b3e5a&quot;}],&quot;slides_to_show_tablet&quot;:&quot;2&quot;,&quot;slides_to_show_mobile&quot;:&quot;1&quot;,&quot;autoplay&quot;:&quot;yes&quot;,&quot;autoplay_speed&quot;:5000,&quot;pause_on_hover&quot;:&quot;yes&quot;,&quot;pause_on_interaction&quot;:&quot;yes&quot;,&quot;infinite&quot;:&quot;yes&quot;,&quot;speed&quot;:500,&quot;offset_sides&quot;:&quot;none&quot;,&quot;arrows&quot;:&quot;yes&quot;,&quot;pagination&quot;:&quot;bullets&quot;,&quot;image_spacing_custom&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:10,&quot;sizes&quot;:[]},&quot;image_spacing_custom_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;image_spacing_custom_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;image_spacing_custom_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-carousel.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-carousel swiper\" role=\"region\" aria-roledescription=\"carousel\" aria-label=\"Carousel\" dir=\"ltr\">\n\t\t\t<div class=\"swiper-wrapper\" aria-live=\"off\">\n\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"1\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"1 von 9\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-27e6060 e-flex e-con-boxed e-con e-child\" data-id=\"27e6060\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-d9d2367 e-con-full e-flex e-con e-child\" data-id=\"d9d2367\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-60ec7e8 elementor-widget elementor-widget-heading\" data-id=\"60ec7e8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">510(k)-Meldung vor dem Inverkehrbringen<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-aaaaca2 elementor-widget elementor-widget-text-editor\" data-id=\"aaaaca2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Recommended for manufacturers who need to demonstrate substantial equivalence to a predicate device. This pathway includes classification support, predicate selection, gap analysis, submission preparation, and responses to FDA review comments.\"}]\" data-inline-monday=\"true\">Empfohlen f\u00fcr Hersteller, die die wesentliche Gleichwertigkeit mit einem Pr\u00e4dikatsprodukt nachweisen m\u00fcssen. Dieser Weg umfasst Unterst\u00fctzung bei der Klassifizierung, der Auswahl des Pr\u00e4dikats, der L\u00fcckenanalyse, der Vorbereitung der Einreichung und der Beantwortung von FDA-Kommentaren. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"2\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"2 von 9\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-efc387a e-flex e-con-boxed e-con e-child\" data-id=\"efc387a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-83a6ab6 e-con-full e-flex e-con e-child\" data-id=\"83a6ab6\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-bf03f94 elementor-widget elementor-widget-heading\" data-id=\"bf03f94\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">FURLS-Ger\u00e4te-Registrierung &amp; Auflistung<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b0d6811 elementor-widget elementor-widget-text-editor\" data-id=\"b0d6811\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"For manufacturers entering the U.S. market or introducing new devices. Sobel manages the registration and listing process in the FURLS database so your products can be legally commercialized in the U.S.\"}]\" data-inline-monday=\"true\">F\u00fcr Hersteller, die in den U.S.-Markt eintreten oder neue Ger\u00e4te einf\u00fchren. Sobel verwaltet den Registrierungs- und Eintragungsprozess in der FURLS-Datenbank, damit Ihre Produkte in den USA legal vermarktet werden k\u00f6nnen. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"3\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"3 von 9\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e257e45 e-flex e-con-boxed e-con e-child\" data-id=\"e257e45\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-2bf73b6 e-con-full e-flex e-con e-child\" data-id=\"2bf73b6\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ada69d5 elementor-widget elementor-widget-heading\" data-id=\"ada69d5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">FURLS Einrichtung Registrierung<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0a0e691 elementor-widget elementor-widget-text-editor\" data-id=\"0a0e691\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Required for foreign establishments manufacturing medical devices for the U.S. market. Sobel creates and registers your facility in the FURLS system, ensuring it complies with FDA establishment registration rules.\"}]\" data-inline-monday=\"true\">Erforderlich f\u00fcr ausl\u00e4ndische Einrichtungen, die Medizinprodukte f\u00fcr den US-Markt herstellen. Sobel erstellt und registriert Ihre Einrichtung im FURLS-System und stellt so sicher, dass sie den Vorschriften der FDA f\u00fcr die Registrierung von Einrichtungen entspricht. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"4\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"4 von 9\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-66c119b e-flex e-con-boxed e-con e-child\" data-id=\"66c119b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-a56d2ab e-con-full e-flex e-con e-child\" data-id=\"a56d2ab\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fb961b8 elementor-widget elementor-widget-heading\" data-id=\"fb961b8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">FURLS Ger\u00e4te- und Anlagenwartung (j\u00e4hrlich)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-17c4a09 elementor-widget elementor-widget-text-editor\" data-id=\"17c4a09\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Ideal for companies that already sell medical devices in the U.S. and must keep their establishment and device listings active. Ensures ongoing compliance with annual FDA registration obligations.\"}]\" data-inline-monday=\"true\">Ideal f\u00fcr Unternehmen, die bereits Medizinprodukte in den USA verkaufen und ihre Betriebs- und Ger\u00e4telisten aktiv halten m\u00fcssen. Gew\u00e4hrleistet die kontinuierliche Einhaltung der j\u00e4hrlichen FDA-Registrierungspflichten. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"5\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"5 von 9\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4ff194e e-flex e-con-boxed e-con e-child\" data-id=\"4ff194e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-51f1a55 e-con-full e-flex e-con e-child\" data-id=\"51f1a55\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c279c5b elementor-widget elementor-widget-heading\" data-id=\"c279c5b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Abschnitt 513(g)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c561daa elementor-widget elementor-widget-text-editor\" data-id=\"c561daa\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Recommended when manufacturers need official clarity from the FDA regarding device classification or applicable regulatory requirements. Sobel prepares and submits the 513(g) request, helping you define the correct regulatory pathway early on.\"}]\" data-inline-monday=\"true\">Empfohlen, wenn Hersteller von der FDA offizielle Klarheit \u00fcber die Klassifizierung von Produkten oder die geltenden regulatorischen Anforderungen ben\u00f6tigen. Sobel bereitet den 513(g)-Antrag vor und reicht ihn ein und hilft Ihnen, den richtigen regulatorischen Weg fr\u00fchzeitig zu definieren. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"6\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"6 von 9\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-418de73 e-flex e-con-boxed e-con e-child\" data-id=\"418de73\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-584356c e-con-full e-flex e-con e-child\" data-id=\"584356c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6dbb74e elementor-widget elementor-widget-heading\" data-id=\"6dbb74e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">MDUFA-Zertifizierung f\u00fcr kleine Unternehmen<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e48ca1a elementor-widget elementor-widget-text-editor\" data-id=\"e48ca1a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Essential for companies seeking reduced FDA user fees. Sobel prepares and submits the documentation required for certification, helping qualified manufacturers significantly decrease FDA submission costs.\"}]\" data-inline-monday=\"true\">Unverzichtbar f\u00fcr Unternehmen, die eine Reduzierung der FDA-Geb\u00fchren anstreben. Sobel bereitet die f\u00fcr die Zertifizierung erforderlichen Unterlagen vor und reicht sie ein. So k\u00f6nnen qualifizierte Hersteller die Kosten f\u00fcr die Einreichung bei der FDA erheblich senken. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"7\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"7 von 9\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-09e981a e-flex e-con-boxed e-con e-child\" data-id=\"09e981a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-ac157a8 e-con-full e-flex e-con e-child\" data-id=\"ac157a8\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-cf35f4d elementor-widget elementor-widget-heading\" data-id=\"cf35f4d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">GUDID (UDI-Registrierung)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-290a7c9 elementor-widget elementor-widget-text-editor\" data-id=\"290a7c9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Required for devices subject to FDA UDI rules. Sobel creates your GUDID account and enters all UDI and label information so your device is properly registered in the FDA database.\"}]\" data-inline-monday=\"true\">Erforderlich f\u00fcr Ger\u00e4te, die den UDI-Vorschriften der FDA unterliegen. Sobel erstellt Ihr GUDID-Konto und gibt alle UDI- und Etiketteninformationen ein, damit Ihr Ger\u00e4t ordnungsgem\u00e4\u00df in der FDA-Datenbank registriert wird. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"8\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"8 von 9\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2f1450a e-flex e-con-boxed e-con e-child\" data-id=\"2f1450a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-d008795 e-con-full e-flex e-con e-child\" data-id=\"d008795\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a4b78eb elementor-widget elementor-widget-heading\" data-id=\"a4b78eb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Label-Bewertung<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-37f43a9 elementor-widget elementor-widget-text-editor\" data-id=\"37f43a9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Recommended for manufacturers preparing labels for the U.S. market. Sobel verifies compliance, identifies gaps, and provides actionable guidance to correct or update your labeling according to FDA requirements.\"}]\" data-inline-monday=\"true\">Empfohlen f\u00fcr Hersteller, die Etiketten f\u00fcr den US-amerikanischen Markt vorbereiten. Sobel \u00fcberpr\u00fcft die Einhaltung der Vorschriften, identifiziert L\u00fccken und gibt Ihnen praktische Hinweise zur Korrektur oder Aktualisierung Ihrer Kennzeichnung gem\u00e4\u00df den FDA-Anforderungen. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"9\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"9 von 9\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-bc51486 e-flex e-con-boxed e-con e-child\" data-id=\"bc51486\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-157dd80 e-con-full e-flex e-con e-child\" data-id=\"157dd80\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a997f20 elementor-widget elementor-widget-heading\" data-id=\"a997f20\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Unterst\u00fctzung bei regulatorischen Angelegenheiten (monatliche Beratung)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cd6c24e elementor-widget elementor-widget-text-editor\" data-id=\"cd6c24e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Designed for companies that need ongoing support with FDA-related questions. Provides fast, written regulatory guidance for day-to-day decisions, so your team remains aligned with FDA expectations.\"}]\" data-inline-monday=\"true\">Entwickelt f\u00fcr Unternehmen, die kontinuierliche Unterst\u00fctzung bei FDA-bezogenen Fragen ben\u00f6tigen. Bietet schnelle, schriftliche Anleitungen f\u00fcr allt\u00e4gliche Entscheidungen, damit Ihr Team die Erwartungen der FDA erf\u00fcllen kann. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<div class=\"elementor-swiper-button elementor-swiper-button-prev\" role=\"button\" tabindex=\"0\" aria-label=\"Voriger\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-eicon-chevron-left\" viewBox=\"0 0 1000 1000\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M646 125C629 125 613 133 604 142L308 442C296 454 292 471 292 487 292 504 296 521 308 533L604 854C617 867 629 875 646 875 663 875 679 871 692 858 704 846 713 829 713 812 713 796 708 779 692 767L438 487 692 225C700 217 708 204 708 187 708 171 704 154 692 142 675 129 663 125 646 125Z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t\t<div class=\"elementor-swiper-button elementor-swiper-button-next\" role=\"button\" tabindex=\"0\" aria-label=\"N\u00e4chster\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-eicon-chevron-right\" viewBox=\"0 0 1000 1000\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M696 533C708 521 713 504 713 487 713 471 708 454 696 446L400 146C388 133 375 125 354 125 338 125 325 129 313 142 300 154 292 171 292 187 292 204 296 221 308 233L563 492 304 771C292 783 288 800 288 817 288 833 296 850 308 863 321 871 338 875 354 875 371 875 388 867 400 854L696 533Z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t\t\t\t<div class=\"swiper-pagination\"><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0a1174a elementor-widget elementor-widget-text-editor\" data-id=\"0a1174a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"attributes\":{\"bold\":true},\"insert\":\"Our medical device regulatory consulting approach bridges knowledge gaps, reduces risk, and accelerates your time-to-market.\"}]\" data-inline-monday=\"true\"><strong>Unser Beratungsansatz zur Regulierung von Medizinprodukten schlie\u00dft Wissensl\u00fccken, reduziert Risiken und beschleunigt Ihre Markteinf\u00fchrung.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9c6e17d e-flex e-con-boxed e-con e-parent\" data-id=\"9c6e17d\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-df067c7 e-con-full e-flex e-con e-child\" data-id=\"df067c7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-458ccc0 elementor-widget__width-inherit elementor-widget-divider--view-line elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"458ccc0\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9b45320 elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"9b45320\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Verwandte Dienstleistungen <br><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5218ed1 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"5218ed1\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"With Sobel, you eliminate uncertainty and prevent common mistakes that compromise timelines and budgets. You can also have support on these complementary services:\"}]\" data-inline-monday=\"true\">Mit Sobel beseitigen Sie Unsicherheiten und vermeiden h\u00e4ufige Fehler, die Zeitpl\u00e4ne und Budgets gef\u00e4hrden. Sie k\u00f6nnen auch Unterst\u00fctzung bei diesen erg\u00e4nzenden Dienstleistungen erhalten: <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7ff23d6 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"7ff23d6\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-34229c3 e-con-full e-flex e-con e-child\" data-id=\"34229c3\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-95e6e5b elementor-widget elementor-widget-heading\" data-id=\"95e6e5b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Biologische Bewertung (BEP, BER)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-996a9c7 elementor-widget elementor-widget-text-editor\" data-id=\"996a9c7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"attributes\":{\"background\":\"var(--color-egg_yolk-selected)\"},\"insert\":\"BEP, BER, and toxicological support. Clear, defensible biological evaluation documentation.\"}]\" data-inline-monday=\"true\">BEP, BER, und toxikologische Unterst\u00fctzung. Klare, vertretbare Dokumentation der biologischen Bewertung. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a8ba134 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"a8ba134\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/sobelconsult.com\/de\/our-solutions-usa\/biological-evaluation-medical-device\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Mehr sehen<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7c1f729 e-con-full e-flex e-con e-child\" data-id=\"7c1f729\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3efdcbd elementor-widget elementor-widget-heading\" data-id=\"3efdcbd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">US-Agentendienst<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-49e6c81 elementor-widget elementor-widget-text-editor\" data-id=\"49e6c81\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7d42130 elementor-widget elementor-widget-text-editor\" data-id=\"7d42130\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><div class=\"elementor-element elementor-element-7d42130 elementor-widget elementor-widget-text-editor\" data-id=\"7d42130\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Navigate market access in the U.S.A. with Sobel as your device US Agent.\"}]\" data-inline-monday=\"true\">Navigieren Sie durch den Marktzugang in den USA mit Sobel als Ihrem US-Agent.<\/p><\/div><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-45c8e66 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"45c8e66\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/sobelconsult.com\/de\/our-solutions-usa\/fda-us-agent\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Mehr sehen<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e62467d e-con-full e-flex e-con e-child\" data-id=\"e62467d\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e757528 elementor-widget elementor-widget-heading\" data-id=\"e757528\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Unterst\u00fctzung im Qualit\u00e4tsmanagement<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c99a659 elementor-widget elementor-widget-text-editor\" data-id=\"c99a659\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"attributes\":{\"background\":\"var(--color-bright-green-selected)\"},\"insert\":\"Align your QMS with FDA 21 CFR 820, ISO 13485, and MDSAP in the U.S.A.\"}]\" data-inline-monday=\"true\">Richten Sie Ihr QMS an FDA 21 CFR 820, ISO 13485 und MDSAP in den USA aus.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-86776d5 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"86776d5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/sobelconsult.com\/de\/our-solutions-usa\/medical-device-quality-consulting\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Mehr sehen<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1a9afd2 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"1a9afd2\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-8012677 e-con-full e-flex e-con e-child\" data-id=\"8012677\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-4ce197a e-con-full e-flex e-con e-child\" data-id=\"4ce197a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-89b1268 elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"89b1268\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Sind Sie bereit, Ihre FDA-Konformit\u00e4t zu beschleunigen?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a5f1acc elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"a5f1acc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Sobel bietet einen umfassenden, strategischen und praktischen Ansatz f\u00fcr die Beratung bei der Regulierung von Medizinprodukten und verschafft Ihrem Unternehmen die Klarheit, das Vertrauen und die regulatorische Bereitschaft, die es braucht, um auf dem US-Markt erfolgreich zu sein.<\/p><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Contact us to start your FDA compliance pathway with confidence.\"}]\" data-inline-monday=\"true\"><strong>Setzen Sie sich mit uns in Verbindung, um Ihren Weg zur FDA-Konformit\u00e4t mit Zuversicht zu beginnen.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-31e2763 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"31e2763\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6NzM0MywidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Holen Sie sich Expertenunterst\u00fctzung<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-bf3a548 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"bf3a548\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-63caaba elementor-widget__width-inherit elementor-widget elementor-widget-toggle\" data-id=\"63caaba\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"toggle.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1041\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-1041\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Haben Sie noch Fragen? Schauen Sie in unsere FAQ <\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1041\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-1041\"><p><b>1. Was ist der erste regulatorische Schritt beim Eintritt in den US-Markt f\u00fcr Medizinprodukte?<\/b><\/p>\n<p>Die meisten Unternehmen beginnen mit der Bestimmung ihrer Produktklassifizierung (Klasse I, II oder III) und der Identifizierung des anwendbaren regulatorischen Weges, wie 510(k), De Novo, PMA oder Ausnahme. In diesem Schritt wird festgelegt, welche Dokumentations-, Test- und Registrierungsaktivit\u00e4ten erforderlich sind. <\/p>\n<p><b>2. Woher wei\u00df ich, ob mein Ger\u00e4t einen 510(k), De Novo oder PMA Antrag ben\u00f6tigt?<\/b><\/p>\n<p>Welcher Weg der richtige ist, h\u00e4ngt von der beabsichtigten Verwendung Ihres Produkts, dem Risikograd und der Existenz eines Pr\u00e4dikatsprodukts auf dem US-Markt ab. Die Analyse der Klassifizierung und die Identifizierung der Pr\u00e4dikate sind wichtige erste Schritte. Sobel unterst\u00fctzt Sie bei der Bewertung aller verf\u00fcgbaren Optionen. <\/p>\n<p><b>3. Muss ich mein Unternehmen bei der FDA registrieren lassen, bevor ich ein Produkt verkaufe?<\/b><\/p>\n<p>Ja. Alle Hersteller, einschlie\u00dflich ausl\u00e4ndischer Unternehmen, m\u00fcssen \u00fcber das FURLS-System eine Anlagenregistrierung und eine Ger\u00e4teliste ausf\u00fcllen. Diese Registrierungen m\u00fcssen ebenfalls j\u00e4hrlich erneuert werden.  <\/p>\n<p><b>4. Was ist UDI und ben\u00f6tige ich eine GUDID-Registrierung?<\/b><\/p>\n<p>Die meisten in den USA verkauften Ger\u00e4te m\u00fcssen mit einer eindeutigen Ger\u00e4tekennung (Unique Device Identifier, UDI) versehen sein, und die Informationen m\u00fcssen in die GUDID-Datenbank der FDA eingegeben werden. Sobel erstellt Ihr Konto und erfasst alle erforderlichen Ger\u00e4tedaten, aber die UDI selbst muss vom Hersteller bereitgestellt werden. <\/p>\n<p><b>5. Kann Sobel Ihnen helfen festzustellen, welche Dokumente f\u00fcr die Einhaltung der FDA-Vorschriften fehlen?<\/b><\/p>\n<p>Ja. Sobel f\u00fchrt detaillierte Bewertungen der regulatorischen L\u00fccken durch, um fehlende Tests, unvollst\u00e4ndige Abschnitte oder Dokumentationen, die nicht den FDA-Anforderungen entsprechen, zu identifizieren. Dies verhindert Nacharbeit und beschleunigt den \u00dcberpr\u00fcfungsprozess.  <\/p>\n<p><b>6. Was geschieht, wenn die FDA Kommentare zur \u00dcberpr\u00fcfung abgibt oder zus\u00e4tzliche Informationen anfordert?<\/b><\/p>\n<p>Sobel unterst\u00fctzt Sie dabei, die Kommentare der FDA zu verstehen, zu interpretieren und darauf zu antworten. Klare, gut strukturierte Antworten sind unerl\u00e4sslich, um zu vermeiden, dass sich der Pr\u00fcfzyklus verl\u00e4ngert oder zus\u00e4tzliche Fragerunden ausgel\u00f6st werden. <\/p>\n<p><b>7. Habe ich Anspruch auf erm\u00e4\u00dfigte Einreichungsgeb\u00fchren im Rahmen des MDUFA Small Business Program?<\/b><\/p>\n<p>Es kommt darauf an. Die Zertifizierung als Kleinunternehmen kann die FDA-Geb\u00fchren erheblich reduzieren, erfordert aber eine spezielle Finanzdokumentation und einen formellen Antrag bei der FDA. Sobel verwaltet den Einreichungs- und Kommunikationsprozess f\u00fcr diese Zertifizierung.  <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Fachkundige Beratung f\u00fcr Medizinprodukte bei der Einreichung von Antr\u00e4gen bei der FDA, Registrierung, UDI und Einhaltung von Vorschriften.<\/p>\n","protected":false},"author":11,"featured_media":25337,"parent":7783,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-4809","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.3 (Yoast SEO v26.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Medizinprodukte-Regulierungsberatung | Spezialisierte 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