{"id":47367,"date":"2026-11-01T19:51:18","date_gmt":"2026-11-01T22:51:18","guid":{"rendered":"https:\/\/sobelconsult.com\/home\/unsere-losungen-2\/vereinigte-staaten\/"},"modified":"2026-11-01T19:53:26","modified_gmt":"2026-11-01T22:53:26","slug":"vereinigte-staaten","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/de\/home\/unsere-losungen-2\/vereinigte-staaten\/","title":{"rendered":"Vereinigte Staaten"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"47367\" class=\"elementor elementor-47367 elementor-47212\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3973c3f e-flex e-con-boxed e-con e-child\" data-id=\"3973c3f\" 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-dcd2d90 elementor-widget elementor-widget-html\" data-id=\"dcd2d90\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"sbm\">\n<nav class=\"sbm-crumb sb-crumb\" aria-label=\"Breadcrumb\"><a href=\"\/\">Startseite<\/a><span aria-hidden=\"true\">\u203a<\/span><a href=\"https:\/\/sobelconsult.com\/de\/home\/unsere-losungen-2\/\">L\u00f6sungen<\/a><span aria-hidden=\"true\">\u203a<\/span><span aria-current=\"page\">Vereinigte Staaten<\/span><\/nav>\n<div class=\"sbm-grid\">\n<div class=\"sbm-txt\">\n<p class=\"sbm-eye\">Medizinprodukte \u00b7 Kosmetika<\/p>\n<h1 class=\"sbm-h1\">Ihr Zulassungsweg in den <span class=\"sbm-gold\">Vereinigten Staaten<\/span>.<\/h1>\n<p class=\"sbm-lead\">Medizinprodukte und Kosmetika unterliegen der Regulierung durch die FDA. Wir legen Ihren Zulassungsweg fest, bereiten Ihre Unterlagen vor und fungieren als Ihr US-Beauftragter.<\/p>\n<div class=\"sbm-ctas\"><a class=\"sbm-btn\" href=\"#footer-cta\">Erstberatung buchen<\/a><a class=\"sbm-link\" href=\"#us-products\">W\u00e4hlen Sie Ihr Produkt aus \u2192<\/a><\/div>\n<p class=\"sbm-trust\">Medizinprodukte \u00b7 Kosmetika \u00b7 ISO 9001-zertifiziert in Brasilien \u00b7 Service in PT \u00b7 EN \u00b7 DE<\/p>\n<\/div>\n<div class=\"sbm-photo\"><img fetchpriority=\"high\" decoding=\"async\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-market-usa-capitol.png\" alt=\"Das Kapitol der Vereinigten Staaten in Washington, D.C., mit der amerikanischen Flagge zur goldenen Stunde\" width=\"1184\" height=\"896\" fetchpriority=\"high\"><\/div>\n<\/div>\n<\/div>\n<style>\n.sbm{font-family:'Host Grotesk',system-ui,sans-serif;color:#2B2E34;padding-top:17px}\n.sbm .sbm-crumb{display:flex;align-items:center;gap:8px;margin:0 0 32px;font-size:14px;line-height:20px;color:#4F535B;white-space:nowrap;min-width:0}\n.sbm .sbm-crumb a{color:#4F535B;text-decoration:none;font-weight:400;font-size:inherit;line-height:inherit;font-family:inherit}\n.sbm .sbm-crumb a:hover,.sbm .sbm-crumb a:focus{color:#051B5A;text-decoration:underline}\n.sbm .sbm-crumb [aria-current]{color:#051B5A;font-weight:600;overflow:hidden;text-overflow:ellipsis;min-width:0}\n.sbm-grid{display:flex;gap:48px;align-items:stretch}\n.sbm-txt{flex:1 1 55%;display:flex;flex-direction:column;min-width:0}\n.sbm .sbm-eye{display:flex;align-items:center;gap:10px;margin:0;font-size:13px;font-weight:600;letter-spacing:.16em;text-transform:uppercase;color:#051B5A;line-height:1.4}\n.sbm .sbm-eye:before{content:\"\";flex:0 0 9px;width:9px;height:9px;border-radius:50%;background:#F2B705}\n.sbm h1.sbm-h1{font-family:Lora,Georgia,serif;font-weight:700;font-size:50px;line-height:1.12;color:#051B5A;margin:22px 0 0;letter-spacing:0;text-transform:none}\n.sbm .sbm-gold{color:#F2B705}\n.sbm .sbm-lead{font-size:20px;line-height:1.55;color:#051B5A;margin:26px 0 0}\n.sbm-ctas{display:flex;flex-wrap:wrap;align-items:center;gap:24px;margin-top:32px}\n.sbm .sbm-btn{display:inline-flex;align-items:center;justify-content:center;min-height:52px;background:#F2B705;color:#3A2B00;font-weight:600;font-size:16px;line-height:1.3;padding:14px 28px;border-radius:999px;text-decoration:none;border:0;text-align:center}\n.sbm .sbm-btn:hover,.sbm .sbm-btn:focus{background:#E0A800;color:#3A2B00}\n.sbm .sbm-link{font-weight:600;font-size:18px;color:#051B5A;text-decoration:underline;text-decoration-color:#F2B705;text-underline-offset:4px}\n.sbm .sbm-link:hover,.sbm .sbm-link:focus{color:#051B5A;text-decoration-thickness:2px}\n.sbm .sbm-trust{font-size:14px;line-height:1.5;color:#4F535B;margin:36px 0 0}\n.sbm-photo{flex:0 1 45%;position:relative;min-height:320px;border-radius:22px;overflow:hidden;box-shadow:0 12px 32px rgba(7,31,99,.12)}\n.sbm-photo img{position:absolute;inset:0;width:100%!important;height:100%!important;max-width:none!important;object-fit:cover;object-position:50% 50%;border-radius:22px}\n@media (max-width:1024px){.sbm h1.sbm-h1{font-size:42px}.sbm-grid{gap:32px}}\n@media (min-width:1025px) and (max-height:840px){.sbm h1.sbm-h1{font-size:42px}.sbm .sbm-lead{margin-top:20px}.sbm-ctas{margin-top:28px}.sbm .sbm-trust{margin-top:28px}}\n@media (max-width:860px){.sbm-grid{flex-direction:column}.sbm-photo{flex-basis:auto;width:100%;min-height:0;height:300px}}\n@media (max-width:767px){.sbm{padding-top:0}.sbm .sbm-crumb{margin-bottom:20px;font-size:13px}.sbm-txt{text-align:center}.sbm-txt .sbm-eye{justify-content:center}.sbm h1.sbm-h1{font-size:32px;margin-top:16px}.sbm .sbm-lead{font-size:18px;margin-top:20px}.sbm-ctas{flex-direction:column;gap:12px;margin-top:24px}.sbm .sbm-btn{width:100%}.sbm .sbm-trust{margin-top:24px}.sbm-photo{height:240px}}\n<\/style>\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-43b7688 e-flex e-con-boxed e-con e-parent\" data-id=\"43b7688\" 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-f78be9d e-con-full e-flex e-con e-child\" data-id=\"f78be9d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7cdaacd elementor-widget elementor-widget-heading\" data-id=\"7cdaacd\" 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<p class=\"elementor-heading-title elementor-size-default\">WO SIE HERKOMMEN<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-75e1abf elementor-widget elementor-widget-heading\" data-id=\"75e1abf\" 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\">Zwei Ausgangspunkte, ein Markt<\/h2>\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-75ffb3a e-con-full e-flex e-con e-child\" data-id=\"75ffb3a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-bff56ef e-con-full e-flex e-con e-child\" data-id=\"bff56ef\" 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-0ba9d0f elementor-widget elementor-widget-heading\" data-id=\"0ba9d0f\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Zum ersten Mal in den USA<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-abb103b elementor-widget elementor-widget-text-editor\" data-id=\"abb103b\" 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>Sie befinden sich au\u00dferhalb der Vereinigten Staaten und m\u00f6chten amerikanische Kunden mit einem klaren Plan ansprechen.<\/p><ul class=\"sb-li\" style=\"margin:12px 0 0;padding-left:18px;color:#2B2E34;line-height:1.7\"><li>Ihr FDA-Verfahren steht fest: 510(k), De Novo oder PMA<\/li><li>Registrierung Ihres Unternehmens mit Sobel als Ihrem US-Beauftragten<\/li><li>Kosmetika: MoCRA-Registrierung, Listung und Sicherheitsnachweis<\/li><\/ul>\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-678f419 e-con-full e-flex e-con e-child\" data-id=\"678f419\" 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-eed8928 elementor-widget elementor-widget-heading\" data-id=\"eed8928\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Bereits in einem anderen Markt zugelassen<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7319913 elementor-widget elementor-widget-text-editor\" data-id=\"7319913\" 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>Ihr Produkt ist bereits in Brasilien oder Europa auf dem Markt, und die USA sind Ihr n\u00e4chster Schritt.<\/p><ul class=\"sb-li\" style=\"margin:12px 0 0;padding-left:18px;color:#2B2E34;line-height:1.7\"><li>Was l\u00e4sst sich aus Ihren ANVISA- oder CE-Unterlagen wiederverwenden?<\/li><li>L\u00fccken hinsichtlich der FDA-Vorschriften und der QMSR auf der Grundlage der ISO 13485<\/li><li>An die US-amerikanischen Anforderungen angepasste Etiketten und Angaben<\/li><\/ul>\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-2c6782d e-flex e-con-boxed e-con e-parent\" data-id=\"2c6782d\" data-element_type=\"container\" data-e-type=\"container\" id=\"us-products\" 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-a296a85 animated-slow elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"a296a85\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;,&quot;_animation_delay&quot;:200}\" 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\">Was bringen Sie in die USA mit?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-dc1e849 e-flex e-con-boxed e-con e-child\" data-id=\"dc1e849\" data-element_type=\"container\" data-e-type=\"container\" id=\"regulatory-path\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-56a071b animated-slow elementor-widget__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"56a071b\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;,&quot;_animation_delay&quot;:400}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">F\u00fcr jedes Produkt gelten eigene FDA-Vorschriften. W\u00e4hlen Sie Ihr Produkt aus, um den gesamten Prozess zu durchlaufen.<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-8c191d6 sobel-solutions-section e-con-full e-flex e-con e-child\" data-id=\"8c191d6\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;none&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-8b9033b e-con-full e-flex e-con e-child\" data-id=\"8b9033b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-1d29157 e-con-full e-flex e-con e-child\" data-id=\"1d29157\" 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-4ace369 elementor-widget elementor-widget-image\" data-id=\"4ace369\" 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=\"800\" height=\"534\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-md_card_dental-implant_gloved-hand-1024x683.webp\" class=\"attachment-large size-large wp-image-47090\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-md_card_dental-implant_gloved-hand-1024x683.webp 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-md_card_dental-implant_gloved-hand-300x200.webp 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-md_card_dental-implant_gloved-hand-768x512.webp 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-md_card_dental-implant_gloved-hand.webp 1248w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\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<div class=\"elementor-element elementor-element-5ddef11 e-con-full icone-segmento e-flex e-con e-child\" data-id=\"5ddef11\" 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-718a074 elementor-widget elementor-widget-image\" data-id=\"718a074\" 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=\"500\" height=\"500\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/4-4.png\" class=\"attachment-large size-large wp-image-47094\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/4-4.png 500w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/4-4-300x300.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/4-4-150x150.png 150w\" sizes=\"(max-width: 500px) 100vw, 500px\" \/>\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<div class=\"elementor-element elementor-element-f6bb005 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"f6bb005\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Medizinprodukte<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-223c9b7 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"223c9b7\" 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>Ger\u00e4te, Implantate und Software \u2013 von der Wahl des Zulassungsweges bis zum Antrag bei der FDA.<\/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-bca47e9 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"bca47e9\" 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 elementor-animation-grow\" href=\"https:\/\/sobelconsult.com\/de\/our-solutions-usa\/\">\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<i aria-hidden=\"true\" class=\" arrow_right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Medizinprodukte in den USA<\/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<div class=\"elementor-element elementor-element-d39bd55 e-con-full e-flex e-con e-child\" data-id=\"d39bd55\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-d41995f e-con-full e-flex e-con e-child\" data-id=\"d41995f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;,&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_scale_effect&quot;:&quot;yes&quot;,&quot;motion_fx_scale_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;motion_fx_scale_direction&quot;:&quot;out-in&quot;,&quot;motion_fx_scale_range&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:20,&quot;end&quot;:80}},&quot;motion_fx_devices&quot;:[&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet&quot;,&quot;mobile&quot;]}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-524afc4 elementor-widget elementor-widget-image\" data-id=\"524afc4\" 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=\"800\" height=\"534\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-cos_card_serum-dropper_hand-1024x683.webp\" class=\"attachment-large size-large wp-image-47098\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-cos_card_serum-dropper_hand-1024x683.webp 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-cos_card_serum-dropper_hand-300x200.webp 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-cos_card_serum-dropper_hand-768x512.webp 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/sobel-cos_card_serum-dropper_hand.webp 1248w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\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<div class=\"elementor-element elementor-element-caee5a2 e-con-full icone-segmento e-flex e-con e-child\" data-id=\"caee5a2\" 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-1471874 elementor-widget elementor-widget-image\" data-id=\"1471874\" 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 loading=\"lazy\" decoding=\"async\" width=\"500\" height=\"500\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/5-4.png\" class=\"attachment-large size-large wp-image-47102\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/5-4.png 500w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/5-4-300x300.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/11\/5-4-150x150.png 150w\" sizes=\"(max-width: 500px) 100vw, 500px\" \/>\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<div class=\"elementor-element elementor-element-e067318 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"e067318\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Kosmetika<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-558b144 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"558b144\" 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>Hautpflege, Make-up und K\u00f6rperpflege \u2013 von der MoCRA-Registrierung bis zur Kennzeichnung.<\/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-8a60370 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"8a60370\" 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 elementor-animation-grow\" href=\"https:\/\/sobelconsult.com\/de\/our-solutions-cosmetics-usa\/\">\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<i aria-hidden=\"true\" class=\" arrow_right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Kosmetik in den USA<\/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<\/div>\n\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-268b121 e-flex e-con-boxed e-con e-parent\" data-id=\"268b121\" data-element_type=\"container\" data-e-type=\"container\" id=\"local-presence\" 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-65d4d5f elementor-widget elementor-widget-html\" data-id=\"65d4d5f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"sbg\" id=\"us-services\">\n<p class=\"sbg-ey\" data-k=\"ey\">DIENSTLEISTUNGEN IN DEN VEREINIGTEN STAATEN<\/p>\n<h2 class=\"sbg-h\" data-k=\"h\">Unser gesamtes Leistungsspektrum f\u00fcr den US-Markt<\/h2>\n<p class=\"sbg-sub\" data-k=\"sub\">Strategie, Dokumentation und Vertretung vor der FDA \u2013 alles aus einer Hand.<\/p>\n<div class=\"sbg-f\" role=\"group\" aria-label=\"Filter by product\">\n<button type=\"button\" class=\"sbg-c on\" data-f=\"all\" data-k=\"all\">Alle<\/button>\n<button type=\"button\" class=\"sbg-c\" data-f=\"md\"><span class=\"sbg-d\" style=\"background:#2A72C8\"><\/span><span data-k=\"md\">Medizinprodukte<\/span><\/button>\n<button type=\"button\" class=\"sbg-c\" data-f=\"co\"><span class=\"sbg-d\" style=\"background:#9471CF\"><\/span><span data-k=\"co\">Kosmetika<\/span><\/button>\n<\/div>\n<div class=\"sbg-g\">\n<a class=\"sbg-t\" data-s=\"md\" href=\"https:\/\/sobelconsult.com\/de\/regulatory-qualitaet\/#registration\"><h3 data-k=\"t1\">Regulatorische Strategie und FDA-Verfahren<\/h3><p data-k=\"d1\">Klassifizierung, Produktcode und der richtige Zulassungsweg: 510(k), De Novo oder PMA.<\/p><span class=\"sbg-tg\"><i class=\"md\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"md\" href=\"https:\/\/sobelconsult.com\/de\/our-solutions-usa\/fda-medical-device-regulatory-consulting\/\"><h3 data-k=\"t2\">510(k)-, De-Novo- und PMA-Antr\u00e4ge<\/h3><p data-k=\"d2\">Einreichungsunterlagen und Antworten auf Anfragen der FDA.<\/p><span class=\"sbg-tg\"><i class=\"md\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"md\" href=\"https:\/\/sobelconsult.com\/de\/regulatory-qualitaet\/#quality-systems\"><h3 data-k=\"t3\">Qualit\u00e4tssicherungssystem (QMSR)<\/h3><p data-k=\"d3\">21 CFR 820, nun in \u00dcbereinstimmung mit ISO 13485, sowie Audits.<\/p><span class=\"sbg-tg\"><i class=\"md\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"md\" href=\"https:\/\/sobelconsult.com\/de\/klinische-evidenz-produktsicherheit\/#biological-evaluation\"><h3 data-k=\"t4\">Biologische Beurteilung und klinische Bewertung<\/h3><p data-k=\"d4\">ISO 10993 und klinische Nachweise f\u00fcr die FDA.<\/p><span class=\"sbg-tg\"><i class=\"md\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"co\" href=\"https:\/\/sobelconsult.com\/de\/our-solutions-cosmetics-usa\/fda-facility-registration-for-cosmetics-mocra-compliance\/\"><h3 data-k=\"t5\">MoCRA-Registrierung und -Produktlistung<\/h3><p data-k=\"d5\">Registrierung von Betrieben und Produktzulassung bei der FDA.<\/p><span class=\"sbg-tg\"><i class=\"co\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"co\" href=\"https:\/\/sobelconsult.com\/de\/our-solutions-cosmetics-usa\/fda-safety-substantiation\/\"><h3 data-k=\"t6\">Sicherheitsnachweis und Kennzeichnung<\/h3><p data-k=\"d6\">Sicherheitsnachweise und Kennzeichnungen gem\u00e4\u00df den Vorschriften der FDA.<\/p><span class=\"sbg-tg\"><i class=\"co\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"md co\" href=\"https:\/\/sobelconsult.com\/de\/our-solutions-usa\/fda-us-agent\/\" data-hco=\"\/our-solutions-cosmetics-usa\/fda-agent-service-for-cosmetics\/\"><h3 data-k=\"t7\">US-Beauftragter<\/h3><p data-k=\"d7\">Sobel fungiert als Ihr US-Beauftragter gegen\u00fcber der FDA.<\/p><span class=\"sbg-tg\"><i class=\"md\"><\/i><i class=\"co\"><\/i><\/span><\/a>\n<a class=\"sbg-t\" data-s=\"md co\" href=\"https:\/\/sobelconsult.com\/de\/so-arbeiten-wir\/#shw-models\"><h3 data-k=\"t8\">Laufende Unterst\u00fctzung<\/h3><p data-k=\"d8\">Monatliche 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.elementor-element.elementor-element-caee5a2{width:76px!important;max-width:76px!important;--width:76px;align-self:center!important;margin:-38px auto 6px!important}\n.elementor .elementor-element-2c6782d .elementor-element-5ddef11 img,.elementor .elementor-element-2c6782d .elementor-element-caee5a2 img{width:76px!important;height:76px!important}\n.sbg .sbg-sub{margin-top:14px}\n.sbg .sbg-f{margin-top:20px}\n.sbg .sbg-g{grid-template-columns:repeat(2,minmax(0,1fr));gap:10px;margin-top:20px}\n.sbg .sbg-t{padding:14px 12px;gap:8px;border-radius:14px}\n.sbg .sbg-t h3{font-size:15px;line-height:1.3}\n.sbg .sbg-t p{display:none}\n.sbg .sbg-tg i{width:20px;height:5px}\n.sbg .sbg-c{padding:6px 12px;min-height:40px;font-size:14px}\n}\n<\/style>\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-2ed0715 e-flex e-con-boxed e-con e-parent\" data-id=\"2ed0715\" 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-e15dd9a elementor-widget elementor-widget-html\" data-id=\"e15dd9a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"sbs2\"><a href=\"https:\/\/sobelconsult.com\/de\/home\/unsere-losungen-2\/#sr-guide\" class=\"sbs2-c\"><span class=\"sbs2-i\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"26\" height=\"26\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"#F2B705\" stroke-width=\"1.8\" stroke-linecap=\"round\" stroke-linejoin=\"round\" aria-hidden=\"true\"><circle cx=\"6\" cy=\"19\" r=\"3\"><\/circle><path d=\"M9 19h8.5a3.5 3.5 0 0 0 0-7h-11a3.5 3.5 0 0 1 0-7H15\"><\/path><circle cx=\"18\" cy=\"5\" r=\"3\"><\/circle><\/svg><\/span><span class=\"sbs2-e\">WURDE DAS PRODUKT BEREITS ANDERSWO ZUGELASSEN?<\/span><span class=\"sbs2-t\">Nehmen Sie Ihre ANVISA- oder CE-Unterlagen als Ausgangspunkt<\/span><span class=\"sbs2-d\">Pr\u00fcfen Sie, was f\u00fcr die USA wiederverwendet werden kann, bevor Sie sich auf ein Projekt festlegen.<\/span><span class=\"sbs2-l\">Gestalten Sie Ihren Weg mit Sobel Route \u2192<\/span><\/a><a href=\"https:\/\/sobelconsult.com\/de\/our-solutions-usa\/fda-us-agent\/\" class=\"sbs2-c\"><span class=\"sbs2-i\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"26\" height=\"26\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"#F2B705\" stroke-width=\"1.8\" stroke-linecap=\"round\" stroke-linejoin=\"round\" aria-hidden=\"true\"><path d=\"M12 22s8-4 8-10V5l-8-3-8 3v7c0 6 8 10 8 10z\"><\/path><path d=\"m9 12 2 2 4-4\"><\/path><\/svg><\/span><span class=\"sbs2-e\">BEN\u00d6TIGEN SIE EINEN VERTRETER IN DEN USA?<\/span><span class=\"sbs2-t\">Erforderlich f\u00fcr ausl\u00e4ndische Medizinproduktehersteller<\/span><span class=\"sbs2-d\">Sobel fungiert als Ihr US-Beauftragter gegen\u00fcber der FDA und bietet Ihnen einen einzigen Ansprechpartner f\u00fcr alle Anfragen.<\/span><span class=\"sbs2-l\">Erfahren Sie mehr \u00fcber den US-Vertretungsservice \u2192<\/span><\/a><\/div><style>.sbs2{display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:24px;font-family:'Host Grotesk',sans-serif}.sbs2-c{display:flex;flex-direction:column;gap:10px;background:#051B5A;border-radius:18px;padding:30px;text-decoration:none;transition:transform .25s ease}.sbs2-c:hover{transform:translateY(-3px)}.sbs2-i{width:52px;height:52px;border-radius:50%;border:1.5px solid #F2B705;display:flex;align-items:center;justify-content:center}.sbs2-e{font-size:13px;font-weight:700;letter-spacing:.14em;color:#F2B705;margin-top:6px}.sbs2-t{font-family:Lora,Georgia,serif;font-weight:700;font-size:24px;line-height:1.25;color:#FFFFFF}.sbs2-d{font-size:16px;line-height:1.55;color:#D9DFEE}.sbs2-l{margin-top:auto;padding-top:8px;font-weight:600;color:#F2B705;font-size:15.5px}@media(max-width:767px){.sbs2{grid-template-columns:minmax(0,1fr)}.sbs2-t{font-size:21px}}<\/style>\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-a19c938 e-con-full e-flex e-con e-parent\" data-id=\"a19c938\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c25134c elementor-widget elementor-widget-template\" data-id=\"c25134c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"template.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-template\">\n\t\t\t\t\t<div data-elementor-type=\"container\" data-elementor-id=\"46190\" class=\"elementor elementor-46190 elementor-46189 elementor-46189\" data-elementor-post-type=\"elementor_library\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5fc3d48 e-flex e-con-boxed e-con e-parent\" data-id=\"5fc3d48\" data-element_type=\"container\" data-e-type=\"container\" id=\"why-sobel\" 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-629f752 sbw-native e-flex e-con-boxed e-con e-child\" data-id=\"629f752\" 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-f0eb2c5 e-con-full sbw-l e-flex e-con e-child\" data-id=\"f0eb2c5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a36dc14 elementor-widget elementor-widget-heading\" data-id=\"a36dc14\" 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<p class=\"elementor-heading-title elementor-size-default\">Warum Sobel<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3c265d3 elementor-widget elementor-widget-heading\" data-id=\"3c265d3\" 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\">Regulierung als <span class=\"sbw-gold\">Gesch\u00e4ftsentscheidung,<\/span> nicht als Checkliste.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-85f7a25 elementor-widget elementor-widget-text-editor\" data-id=\"85f7a25\" 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>An jedem Projekt arbeiten vier Fachbereiche im selben Team zusammen \u2013 von der ersten Entscheidung bis hin zur Zeit nach der Markteinf\u00fchrung.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a67f4ac e-con-full e-grid e-con e-child\" data-id=\"a67f4ac\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-693f1b5 e-con-full e-flex e-con e-child\" data-id=\"693f1b5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-85f3478 elementor-widget elementor-widget-heading\" data-id=\"85f3478\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Strategie<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-97525b9 elementor-widget elementor-widget-text-editor\" data-id=\"97525b9\" 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>Zun\u00e4chst werden die Klassifizierung und die Marktabfolge festgelegt. Die Wahl der richtigen Klasse vom ersten Tag an verhindert Nacharbeiten.<\/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-6495a0a e-con-full e-flex e-con e-child\" data-id=\"6495a0a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-836adaf elementor-widget elementor-widget-heading\" data-id=\"836adaf\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Eigene Wissenschaft<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-67ceef1 elementor-widget elementor-widget-text-editor\" data-id=\"67ceef1\" 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>Biologische Beurteilung, klinische Bewertung und toxikologische Beurteilung durch unser eigenes Team f\u00fcr klinische Evidenz und Produktsicherheit.<\/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-32f324f e-con-full e-flex e-con e-child\" data-id=\"32f324f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-42f4202 elementor-widget elementor-widget-heading\" data-id=\"42f4202\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Regulierung, f\u00fcnf M\u00e4rkte<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-af07af2 elementor-widget elementor-widget-text-editor\" data-id=\"af07af2\" 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>ANVISA, die FDA, die EU-MDR, die MHRA und Health Canada haben sich untereinander abgestimmt.<\/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-509c85a e-con-full e-flex e-con e-child\" data-id=\"509c85a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e1ba45f elementor-widget elementor-widget-heading\" data-id=\"e1ba45f\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Technologie<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2c8184f elementor-widget elementor-widget-text-editor\" data-id=\"2c8184f\" 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>Ein engagiertes Technologieteam entwickelt die Arbeitsabl\u00e4ufe, die daf\u00fcr sorgen, dass jedes Projekt nachvollziehbar bleibt und termingerecht abgewickelt 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<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4d1d951 e-con-full sbw-card e-flex e-con e-child\" data-id=\"4d1d951\" 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-afde0f5 elementor-widget elementor-widget-text-editor\" data-id=\"afde0f5\" 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>\u201eWir wissen, wie Auditoren denken, denn wir waren selbst einmal einer von ihnen.\u201c<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4b051b4 e-con-full e-flex e-con e-child\" data-id=\"4b051b4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ed4939a elementor-widget elementor-widget-image\" data-id=\"ed4939a\" 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 loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"300\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait-300x300.webp\" class=\"attachment-medium size-medium wp-image-44765\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait-300x300.webp 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait-150x150.webp 150w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait-768x768.webp 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait.webp 800w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/>\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<div class=\"elementor-element elementor-element-0a86da7 e-con-full e-flex e-con e-child\" data-id=\"0a86da7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ea43503 elementor-widget elementor-widget-heading\" data-id=\"ea43503\" 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<p class=\"elementor-heading-title elementor-size-default\">Maik Endler<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d696004 elementor-widget elementor-widget-heading\" data-id=\"d696004\" 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<p class=\"elementor-heading-title elementor-size-default\">Gr\u00fcnder und Gesch\u00e4ftsf\u00fchrer<\/p>\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<div class=\"elementor-element elementor-element-7c430b7 elementor-widget elementor-widget-text-editor\" data-id=\"7c430b7\" 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<ul><li>Maschinenbauingenieur, in Deutschland ausgebildet<\/li><li>Ehemaliger BSI-Auditor (Benannte Stelle)<\/li><li>Branchenerfahrung bei Sirona (jetzt Dentsply Sirona)<\/li><\/ul>\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-87729bb elementor-align-left elementor-widget elementor-widget-button\" data-id=\"87729bb\" 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\/home\/about-us\/\">\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\">Lernen Sie das Team kennen \u2192<\/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\t\t<div class=\"elementor-element elementor-element-446ce21 elementor-widget elementor-widget-html\" data-id=\"446ce21\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<style>.sbw-gold{color:#F2B705}.sbw-eye .elementor-heading-title{display:flex;align-items:center;gap:10px}.sbw-eye .elementor-heading-title:before{content:\"\";width:9px;height:9px;border-radius:50%;background:#F2B705;flex:none}.sbw-list ul{margin:0;padding-left:18px}.sbw-list li{margin:4px 0}.sbw-list li::marker{color:#F2B705}@media(max-width:1024px){.sbw-native > .sbw-l, .sbw-native > .sbw-card{width:100%!important}}<\/style>\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\t\t<\/div>\n\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-bd26599 e-con-full e-flex e-con e-parent\" data-id=\"bd26599\" data-element_type=\"container\" data-e-type=\"container\" id=\"faq\" 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Auf jeder Produktseite finden Sie detaillierte Informationen.<\/p><a class=\"sbf-btn\" href=\"#footer-cta\">Stellen Sie Ihre Frage \u2192<\/a><\/div>\n<div class=\"sbf-list\"><details class=\"sbf-item\" open=\"\"><summary><span>Wer ist in den USA f\u00fcr die Regulierung von Medizinprodukten und Kosmetika zust\u00e4ndig?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>Beide Bereiche werden von der <strong>FDA<\/strong> (U.S. Food and Drug Administration) gem\u00e4\u00df dem Federal Food, Drug, and Cosmetic Act reguliert. F\u00fcr Kosmetika wurden durch den <strong>Modernization of Cosmetics Regulation Act von 2022 (MoCRA)<\/strong> die Registrierung von Betrieben, die Produktlistung sowie der Nachweis der Sicherheit eingef\u00fchrt.<\/p><\/div><\/details><details class=\"sbf-item\"><summary><span>Ben\u00f6tige ich einen US-Beauftragten?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>Bei Medizinprodukten ja. Ausl\u00e4ndische Unternehmen m\u00fcssen bei der Registrierung bei der FDA einen <strong>US-Beauftragten<\/strong> benennen (21 CFR 807.40). Sobel fungiert als Ihr US-Beauftragter. Bei Kosmetika pr\u00fcfen wir, welche Vertretung Ihr Fall erfordert. <a href=\"https:\/\/sobelconsult.com\/de\/our-solutions-usa\/fda-us-agent\/\">Erfahren Sie mehr \u00fcber den US-Beauftragten-Service<\/a>.<\/p><\/div><\/details><details class=\"sbf-item\"><summary><span>Welches FDA-Zulassungsverfahren ist f\u00fcr mein Medizinprodukt erforderlich?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>Dies h\u00e4ngt von der Klassifizierung des Produkts ab. Die meisten Produkte der Klasse II erfordern ein <strong>510(k)<\/strong>-Verfahren, neue Produkte mit geringerem Risiko ohne Referenzprodukt k\u00f6nnen nach <strong>dem De-Novo-Verfahren<\/strong> zugelassen werden, und die meisten Produkte der Klasse III erfordern eine <strong>PMA<\/strong>. Einige Produkte sind von der Einreichung eines Antrags vor dem Inverkehrbringen befreit. Die Festlegung des Zulassungsverfahrens ist der erste Schritt.<\/p><\/div><\/details><details class=\"sbf-item\"><summary><span>Was hat sich mit der FDA-QMSR ge\u00e4ndert?<\/span><i aria-hidden=\"true\"><\/i><\/summary><div class=\"sbf-a\"><p>Seit <strong>dem 2. Februar 2026<\/strong> bezieht die Verordnung zum Qualit\u00e4tsmanagementsystem (21 CFR 820) <strong>die<\/strong> Norm <strong>ISO 13485:2016<\/strong> durch Verweis mit ein. 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Sobel unterst\u00fctzt die Klassifizierung, Registrierung und regulatorische Strategie f\u00fcr die Marktzulassung.<\/p>\n","protected":false},"author":18,"featured_media":25478,"parent":41035,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_angie_page":false,"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-47367","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.8 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Markteintritt in den US-Markt f\u00fcr Medizinprodukte und Kosmetika | Sobel<\/title>\n<meta name=\"description\" content=\"Treten Sie mit einem klaren FDA-Plan in den US-Markt ein: 510(k), De Novo oder PMA, MoCRA-Registrierung und -Listung sowie Sobel als Ihr US-Vertreter.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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