{"id":34945,"date":"2026-05-11T09:28:35","date_gmt":"2026-05-11T12:28:35","guid":{"rendered":"https:\/\/sobelconsult.com\/materiais\/us-510k-se-rationale\/"},"modified":"2026-05-28T16:35:31","modified_gmt":"2026-05-28T19:35:31","slug":"us-510k","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/de\/lp\/medical-devices\/us-510k\/","title":{"rendered":"LP | Medizinische Ger\u00e4te | US 510(k)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"34945\" class=\"elementor elementor-34945 elementor-34916\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-17e8886 e-con-full e-flex e-con e-parent\" data-id=\"17e8886\" 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-59a8218 e-flex e-con-boxed e-con e-child\" data-id=\"59a8218\" 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-97046ca elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"97046ca\" 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=\"741\" height=\"290\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-BlueMain.webp\" class=\"attachment-full size-full wp-image-4514\" alt=\"Logo Sobel Blue\" \/>\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-c8b2150 elementor-align-left borda-piscando elementor-hidden-tablet elementor-hidden-mobile elementor-mobile-align-left elementor-widget elementor-widget-button\" data-id=\"c8b2150\" 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-pulse\" href=\"#cta\">\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\">Sprechen Sie mit einem Spezialisten<\/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-ad33bd2 e-flex e-con-boxed e-con e-child\" data-id=\"ad33bd2\" 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-569e7d2 e-con-full e-flex e-con e-child\" data-id=\"569e7d2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-43b191d elementor-widget elementor-widget-heading\" data-id=\"43b191d\" 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 der 510(k)-Einreichung<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5b78965 elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"5b78965\" 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\">Vermeiden Sie kostspielige <span class=\"hero-blue\">510(k)-\u00dcberarbeitungen<\/span><br \/>bevor Sie einreichen<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-da6b05e elementor-widget__width-initial elementor-widget-mobile__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"da6b05e\" 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>F\u00fcr Medizinprodukteunternehmen, die FDA 510(k)-Dokumentation, Pr\u00e4dikatsstrategie, substanzielle \u00c4quivalenz oder US-Markteinf\u00fchrung vorbereiten.<\/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-2ff170b elementor-widget-mobile__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"2ff170b\" 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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-chevron-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Identifizieren Sie Dokumentationsl\u00fccken vor der \u00dcberpr\u00fcfung durch die FDA<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-chevron-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">\u00dcberpr\u00fcfen Sie die Strategie der Pr\u00e4dikate und der substanziellen \u00c4quivalenz<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-chevron-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Abstimmung von Tests, Kennzeichnung, Angaben und Verwendungszweck<\/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 class=\"elementor-element elementor-element-b3a3bb4 elementor-align-left borda-piscando elementor-mobile-align-left elementor-widget elementor-widget-button\" data-id=\"b3a3bb4\" 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-pulse\" href=\"#cta\">\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\">Meine 510(k)-Reife pr\u00fcfen<\/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 class=\"elementor-element elementor-element-f0814d1 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"f0814d1\" 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>Entwickelt f\u00fcr Unternehmen mit einem definierten Medizinprodukt, einer laufenden Dokumentation oder einem klaren Ziel f\u00fcr den US-Markt.<\/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<\/div>\n\t\t<div class=\"elementor-element elementor-element-716cccf e-transform e-flex e-con-boxed e-con e-parent\" data-id=\"716cccf\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;_transform_translateX_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:-48,&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_translateX_effect_mobile&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;:[]},&quot;_transform_translateY_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-5529cc8 e-con-full e-flex e-con e-child\" data-id=\"5529cc8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5b66c70 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"5b66c70\" 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>Vertraut von Teams des regulierten Marktes<br><\/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-5ae4456 elementor-widget elementor-widget-image-carousel\" data-id=\"5ae4456\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;slides_to_show&quot;:&quot;5&quot;,&quot;slides_to_scroll&quot;:&quot;1&quot;,&quot;navigation&quot;:&quot;none&quot;,&quot;autoplay_speed&quot;:3000,&quot;speed&quot;:1500,&quot;image_spacing_custom&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:4,&quot;sizes&quot;:[]},&quot;slides_to_show_mobile&quot;:&quot;2&quot;,&quot;autoplay&quot;:&quot;yes&quot;,&quot;pause_on_hover&quot;:&quot;yes&quot;,&quot;pause_on_interaction&quot;:&quot;yes&quot;,&quot;infinite&quot;:&quot;yes&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=\"image-carousel.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-image-carousel-wrapper swiper\" role=\"region\" aria-roledescription=\"carousel\" aria-label=\"Image Carousel\" dir=\"ltr\">\n\t\t\t<div class=\"elementor-image-carousel swiper-wrapper\" aria-live=\"off\">\n\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"1 von 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-4-e1785701259234-rrbv89ia8gdxq0r54ih9brlgjfrzbldlpcap9i91vg.webp\" alt=\"Hypera Pharma logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"2 von 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-5-e1785701234356-rrbv7m0bhlhrnrp9xqbl3fixoszsz5sba3zk9l7w70.webp\" alt=\"CMOS Drake\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"3 von 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-6-e1785701205313-rrbv6uqzzeggb2svcwjel4ekgmq5rxs3id2hckcb7g.webp\" alt=\"Pasteur logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"4 von 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-7-e1785701176338-rrbv63hoh7f4ydwgs2r82ta78ggikprvqm5efjgq7w.webp\" alt=\"Ache logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"5 von 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-8-e1785701148522-rrbv5d675uf3xayp1rdo4zxalo28l6veazvszsjr24.webp\" alt=\"Teuto logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"6 von 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-9-e1785701119944-rrbv4lwvnndskm2agxlhmosxdhsldyv6j8yq2ro62k.webp\" alt=\"ADV Farma logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"7 von 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-10-e1785701097906-rrbv418fhalhh6wbtonp3u0sb0mioml34em1ioitvg.webp\" alt=\"SIN logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"8 von 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-11-e1785701066264-rrbv383flfhlha2nju29gjdhw2m520deoedzn3q18c.webp\" alt=\"Supera Farma logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"9 von 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-12-e1785701037693-rrbv2gu438ga4l68z0a2y894nwchusd6wngwq2ug8s.webp\" alt=\"Avenca logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"10 von 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-13-e1785701007365-rrbv1omye7dogab7jo39vfdauc7hfv98srwcbs09fg.webp\" alt=\"Dentsply Sirona logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"11 von 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-14-e1785700969629-rrbv0ox36i0s73r3c8ng8ods9p3jbdbfzv3w39h7zw.webp\" alt=\"Fresenius Kabi logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"12 von 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-1-e1785700931897-rrbuzp77ysnvxx6z4t7mlxe9p1zl6vdn6ybfuqy6kc.webp\" alt=\"B Braun logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"13 von 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-2-e1785700906155-rrbuz1p97xrpvo53y11ydlbquf7eufscrq0autx0vw.webp\" alt=\"Surya Brasil logo\" \/><\/figure><\/div><div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"14 von 14\"><figure class=\"swiper-slide-inner\"><img decoding=\"async\" class=\"swiper-slide-image\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/elementor\/thumbs\/logo-client-sobel-cosmetics-3-e1785700805623-rrbuwerk1o5rb1z0ce0mvra6ui7c90bgqo49dvtscc.webp\" alt=\"Baruel logo\" \/><\/figure><\/div>\t\t\t<\/div>\n\t\t\t\t\t\t\t\n\t\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<div class=\"elementor-element elementor-element-56a2afd e-flex e-con-boxed e-con e-parent\" data-id=\"56a2afd\" 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-34425b4 e-con-full e-flex e-con e-child\" data-id=\"34425b4\" 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-eec538f e-con-full e-flex e-con e-child\" data-id=\"eec538f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-53afd88 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"53afd88\" 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\">Ist diese 510(k)-Unterst\u00fctzung das Richtige f\u00fcr Ihr Unternehmen?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fc8e713 elementor-widget elementor-widget-text-editor\" data-id=\"fc8e713\" 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>Dieser Service ist f\u00fcr Teams gedacht, die ein echtes Medizinprodukt f\u00fcr die Pr\u00fcfung durch die FDA vorbereiten, nicht f\u00fcr fr\u00fche Ideen, Kurse oder allgemeine Forschung.<\/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-852bee3 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"852bee3\" 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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 136.967-111.033 248-248 248S8 392.967 8 256 119.033 8 256 8s248 111.033 248 248zM227.314 387.314l184-184c6.248-6.248 6.248-16.379 0-22.627l-22.627-22.627c-6.248-6.249-16.379-6.249-22.628 0L216 308.118l-70.059-70.059c-6.248-6.248-16.379-6.248-22.628 0l-22.627 22.627c-6.248 6.248-6.248 16.379 0 22.627l104 104c6.249 6.249 16.379 6.249 22.628.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Sie haben ein definiertes medizinisches Ger\u00e4t oder einen Prototyp<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 136.967-111.033 248-248 248S8 392.967 8 256 119.033 8 256 8s248 111.033 248 248zM227.314 387.314l184-184c6.248-6.248 6.248-16.379 0-22.627l-22.627-22.627c-6.248-6.249-16.379-6.249-22.628 0L216 308.118l-70.059-70.059c-6.248-6.248-16.379-6.248-22.628 0l-22.627 22.627c-6.248 6.248-6.248 16.379 0 22.627l104 104c6.249 6.249 16.379 6.249 22.628.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Sie bereiten sich auf die Einreichung bei der US FDA vor<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 136.967-111.033 248-248 248S8 392.967 8 256 119.033 8 256 8s248 111.033 248 248zM227.314 387.314l184-184c6.248-6.248 6.248-16.379 0-22.627l-22.627-22.627c-6.248-6.249-16.379-6.249-22.628 0L216 308.118l-70.059-70.059c-6.248-6.248-16.379-6.248-22.628 0l-22.627 22.627c-6.248 6.248-6.248 16.379 0 22.627l104 104c6.249 6.249 16.379 6.249 22.628.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Sie m\u00fcssen Ihren 510(k)-Pfad best\u00e4tigen<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 136.967-111.033 248-248 248S8 392.967 8 256 119.033 8 256 8s248 111.033 248 248zM227.314 387.314l184-184c6.248-6.248 6.248-16.379 0-22.627l-22.627-22.627c-6.248-6.249-16.379-6.249-22.628 0L216 308.118l-70.059-70.059c-6.248-6.248-16.379-6.248-22.628 0l-22.627 22.627c-6.248 6.248-6.248 16.379 0 22.627l104 104c6.249 6.249 16.379 6.249 22.628.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Ihre Dokumentation muss m\u00f6glicherweise von den Beh\u00f6rden \u00fcberpr\u00fcft werden<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 136.967-111.033 248-248 248S8 392.967 8 256 119.033 8 256 8s248 111.033 248 248zM227.314 387.314l184-184c6.248-6.248 6.248-16.379 0-22.627l-22.627-22.627c-6.248-6.249-16.379-6.249-22.628 0L216 308.118l-70.059-70.059c-6.248-6.248-16.379-6.248-22.628 0l-22.627 22.627c-6.248 6.248-6.248 16.379 0 22.627l104 104c6.249 6.249 16.379 6.249 22.628.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Sie brauchen Klarheit, bevor Sie mehr Zeit oder Budget investieren<\/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 class=\"elementor-element elementor-element-27cfaab elementor-widget elementor-widget-text-editor\" data-id=\"27cfaab\" 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\":\"If route, predicate, evidence or eSTAR structure are still uncertain, Sobel can help organize the next step.\"}]\" data-inline-monday=\"true\">Wenn Route, Pr\u00e4dikat, Beweismittel oder eSTAR-Struktur noch unsicher sind, <strong>kann Sobel Ihnen helfen, den n\u00e4chsten Schritt zu organisieren.<\/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<div class=\"elementor-element elementor-element-feea52c e-con-full e-flex e-con e-child\" data-id=\"feea52c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e4dee7e elementor-widget elementor-widget-image\" data-id=\"e4dee7e\" 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=\"1000\" height=\"667\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/04\/biological-evaluation-of-medical-devices.jpg\" class=\"attachment-full size-full wp-image-34166\" alt=\"Women&apos;s hands pointing to information in documents in a business setting.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/04\/biological-evaluation-of-medical-devices.jpg 1000w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/04\/biological-evaluation-of-medical-devices-300x200.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/04\/biological-evaluation-of-medical-devices-768x512.jpg 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/>\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>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6aeb7cf e-con-full e-flex e-con e-parent\" data-id=\"6aeb7cf\" 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-73ed7a9 e-con-full e-flex e-con e-child\" data-id=\"73ed7a9\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3b70d56 elementor-widget elementor-widget-heading\" data-id=\"3b70d56\" 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\">Die meisten 510(k)-Verz\u00f6gerungen beginnen vor der Einreichung\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-355f372 elementor-widget elementor-widget-text-editor\" data-id=\"355f372\" 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>Eine schwache Pr\u00e4dikatsstrategie, unklare Dokumentation oder widerspr\u00fcchliche Angaben k\u00f6nnen zu Fragen der FDA, Nacharbeit und Verz\u00f6gerungen 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-ad9f89b e-flex e-con-boxed e-con e-child\" data-id=\"ad9f89b\" 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-daee997 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"daee997\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeInLeft&quot;,&quot;animation_delay&quot;:0}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-695f0f9 elementor-widget elementor-widget-heading\" data-id=\"695f0f9\" 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\">Allgemeine Probleme<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-88126e0 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"88126e0\" 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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-window-close\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 32H48C21.5 32 0 53.5 0 80v352c0 26.5 21.5 48 48 48h416c26.5 0 48-21.5 48-48V80c0-26.5-21.5-48-48-48zm0 394c0 3.3-2.7 6-6 6H54c-3.3 0-6-2.7-6-6V86c0-3.3 2.7-6 6-6h404c3.3 0 6 2.7 6 6v340zM356.5 194.6L295.1 256l61.4 61.4c4.6 4.6 4.6 12.1 0 16.8l-22.3 22.3c-4.6 4.6-12.1 4.6-16.8 0L256 295.1l-61.4 61.4c-4.6 4.6-12.1 4.6-16.8 0l-22.3-22.3c-4.6-4.6-4.6-12.1 0-16.8l61.4-61.4-61.4-61.4c-4.6-4.6-4.6-12.1 0-16.8l22.3-22.3c4.6-4.6 12.1-4.6 16.8 0l61.4 61.4 61.4-61.4c4.6-4.6 12.1-4.6 16.8 0l22.3 22.3c4.7 4.6 4.7 12.1 0 16.8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Pr\u00e4dikatsvergleich ist unvollst\u00e4ndig<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-window-close\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 32H48C21.5 32 0 53.5 0 80v352c0 26.5 21.5 48 48 48h416c26.5 0 48-21.5 48-48V80c0-26.5-21.5-48-48-48zm0 394c0 3.3-2.7 6-6 6H54c-3.3 0-6-2.7-6-6V86c0-3.3 2.7-6 6-6h404c3.3 0 6 2.7 6 6v340zM356.5 194.6L295.1 256l61.4 61.4c4.6 4.6 4.6 12.1 0 16.8l-22.3 22.3c-4.6 4.6-12.1 4.6-16.8 0L256 295.1l-61.4 61.4c-4.6 4.6-12.1 4.6-16.8 0l-22.3-22.3c-4.6-4.6-4.6-12.1 0-16.8l61.4-61.4-61.4-61.4c-4.6-4.6-4.6-12.1 0-16.8l22.3-22.3c4.6-4.6 12.1-4.6 16.8 0l61.4 61.4 61.4-61.4c4.6-4.6 12.1-4.6 16.8 0l22.3 22.3c4.7 4.6 4.7 12.1 0 16.8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Der Verwendungszweck ist unklar oder inkonsistent<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-window-close\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 32H48C21.5 32 0 53.5 0 80v352c0 26.5 21.5 48 48 48h416c26.5 0 48-21.5 48-48V80c0-26.5-21.5-48-48-48zm0 394c0 3.3-2.7 6-6 6H54c-3.3 0-6-2.7-6-6V86c0-3.3 2.7-6 6-6h404c3.3 0 6 2.7 6 6v340zM356.5 194.6L295.1 256l61.4 61.4c4.6 4.6 4.6 12.1 0 16.8l-22.3 22.3c-4.6 4.6-12.1 4.6-16.8 0L256 295.1l-61.4 61.4c-4.6 4.6-12.1 4.6-16.8 0l-22.3-22.3c-4.6-4.6-4.6-12.1 0-16.8l61.4-61.4-61.4-61.4c-4.6-4.6-4.6-12.1 0-16.8l22.3-22.3c4.6-4.6 12.1-4.6 16.8 0l61.4 61.4 61.4-61.4c4.6-4.6 12.1-4.6 16.8 0l22.3 22.3c4.7 4.6 4.7 12.1 0 16.8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Testnachweise st\u00fctzen die Behauptungen nicht<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-window-close\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 32H48C21.5 32 0 53.5 0 80v352c0 26.5 21.5 48 48 48h416c26.5 0 48-21.5 48-48V80c0-26.5-21.5-48-48-48zm0 394c0 3.3-2.7 6-6 6H54c-3.3 0-6-2.7-6-6V86c0-3.3 2.7-6 6-6h404c3.3 0 6 2.7 6 6v340zM356.5 194.6L295.1 256l61.4 61.4c4.6 4.6 4.6 12.1 0 16.8l-22.3 22.3c-4.6 4.6-12.1 4.6-16.8 0L256 295.1l-61.4 61.4c-4.6 4.6-12.1 4.6-16.8 0l-22.3-22.3c-4.6-4.6-4.6-12.1 0-16.8l61.4-61.4-61.4-61.4c-4.6-4.6-4.6-12.1 0-16.8l22.3-22.3c4.6-4.6 12.1-4.6 16.8 0l61.4 61.4 61.4-61.4c4.6-4.6 12.1-4.6 16.8 0l22.3 22.3c4.7 4.6 4.7 12.1 0 16.8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Die Beschriftung entspricht nicht der Einreichungsstrategie<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-window-close\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 32H48C21.5 32 0 53.5 0 80v352c0 26.5 21.5 48 48 48h416c26.5 0 48-21.5 48-48V80c0-26.5-21.5-48-48-48zm0 394c0 3.3-2.7 6-6 6H54c-3.3 0-6-2.7-6-6V86c0-3.3 2.7-6 6-6h404c3.3 0 6 2.7 6 6v340zM356.5 194.6L295.1 256l61.4 61.4c4.6 4.6 4.6 12.1 0 16.8l-22.3 22.3c-4.6 4.6-12.1 4.6-16.8 0L256 295.1l-61.4 61.4c-4.6 4.6-12.1 4.6-16.8 0l-22.3-22.3c-4.6-4.6-4.6-12.1 0-16.8l61.4-61.4-61.4-61.4c-4.6-4.6-4.6-12.1 0-16.8l22.3-22.3c4.6-4.6 12.1-4.6 16.8 0l61.4 61.4 61.4-61.4c4.6-4.6 12.1-4.6 16.8 0l22.3 22.3c4.7 4.6 4.7 12.1 0 16.8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Technologische Unterschiede werden nicht erkl\u00e4rt<\/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 class=\"elementor-element elementor-element-a61f065 elementor-widget__width-initial elementor-invisible elementor-widget elementor-widget-image\" data-id=\"a61f065\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;tada&quot;}\" 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=\"458\" height=\"458\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/attention-icon.webp\" class=\"attachment-large size-large wp-image-36046\" alt=\"attention icon\" \/>\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-27583e0 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"27583e0\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeInRight&quot;,&quot;animation_delay&quot;:0}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-da16916 elementor-widget elementor-widget-heading\" data-id=\"da16916\" 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\">Was es verursachen kann<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-03d996b elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"03d996b\" 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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check-square\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M400 480H48c-26.51 0-48-21.49-48-48V80c0-26.51 21.49-48 48-48h352c26.51 0 48 21.49 48 48v352c0 26.51-21.49 48-48 48zm-204.686-98.059l184-184c6.248-6.248 6.248-16.379 0-22.627l-22.627-22.627c-6.248-6.248-16.379-6.249-22.628 0L184 302.745l-70.059-70.059c-6.248-6.248-16.379-6.248-22.628 0l-22.627 22.627c-6.248 6.248-6.248 16.379 0 22.627l104 104c6.249 6.25 16.379 6.25 22.628.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Zus\u00e4tzliche Fragen der FDA<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check-square\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M400 480H48c-26.51 0-48-21.49-48-48V80c0-26.51 21.49-48 48-48h352c26.51 0 48 21.49 48 48v352c0 26.51-21.49 48-48 48zm-204.686-98.059l184-184c6.248-6.248 6.248-16.379 0-22.627l-22.627-22.627c-6.248-6.248-16.379-6.249-22.628 0L184 302.745l-70.059-70.059c-6.248-6.248-16.379-6.248-22.628 0l-22.627 22.627c-6.248 6.248-6.248 16.379 0 22.627l104 104c6.249 6.25 16.379 6.25 22.628.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Ersuchen um Kl\u00e4rung oder neue Beweise<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check-square\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M400 480H48c-26.51 0-48-21.49-48-48V80c0-26.51 21.49-48 48-48h352c26.51 0 48 21.49 48 48v352c0 26.51-21.49 48-48 48zm-204.686-98.059l184-184c6.248-6.248 6.248-16.379 0-22.627l-22.627-22.627c-6.248-6.248-16.379-6.249-22.628 0L184 302.745l-70.059-70.059c-6.248-6.248-16.379-6.248-22.628 0l-22.627 22.627c-6.248 6.248-6.248 16.379 0 22.627l104 104c6.249 6.25 16.379 6.25 22.628.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Verz\u00f6gerungen bei der Einreichung oder Freigabe<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check-square\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M400 480H48c-26.51 0-48-21.49-48-48V80c0-26.51 21.49-48 48-48h352c26.51 0 48 21.49 48 48v352c0 26.51-21.49 48-48 48zm-204.686-98.059l184-184c6.248-6.248 6.248-16.379 0-22.627l-22.627-22.627c-6.248-6.248-16.379-6.249-22.628 0L184 302.745l-70.059-70.059c-6.248-6.248-16.379-6.248-22.628 0l-22.627 22.627c-6.248 6.248-6.248 16.379 0 22.627l104 104c6.249 6.25 16.379 6.25 22.628.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Zus\u00e4tzliche Kosten f\u00fcr Vorschriften, Tests oder Dokumentation<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-check-square\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M400 480H48c-26.51 0-48-21.49-48-48V80c0-26.51 21.49-48 48-48h352c26.51 0 48 21.49 48 48v352c0 26.51-21.49 48-48 48zm-204.686-98.059l184-184c6.248-6.248 6.248-16.379 0-22.627l-22.627-22.627c-6.248-6.248-16.379-6.249-22.628 0L184 302.745l-70.059-70.059c-6.248-6.248-16.379-6.248-22.628 0l-22.627 22.627c-6.248 6.248-6.248 16.379 0 22.627l104 104c6.249 6.25 16.379 6.25 22.628.001z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Interne Unsicherheit vor der Einreichung<\/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\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-fc117b4 e-con-full e-flex e-con e-parent\" data-id=\"fc117b4\" 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-04f82fc e-flex e-con-boxed e-con e-child\" data-id=\"04f82fc\" 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-a20ea2b e-con-full e-flex e-con e-child\" data-id=\"a20ea2b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-10a050a elementor-widget elementor-widget-heading\" data-id=\"10a050a\" 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<h4 class=\"elementor-heading-title elementor-size-default\">DIE L\u00d6SUNG<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bf93512 elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"bf93512\" 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\">Verwandeln Sie verstreute Ger\u00e4teinformationen in eine klare 510(k)-Strategie\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-06e4964 elementor-widget__width-initial elementor-widget-mobile__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"06e4964\" 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 hilft Ihnen dabei, Ihren regulatorischen Weg, Dokumentationsl\u00fccken und die Einreichungslogik zu organisieren, bevor Sie weitermachen.<\/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-1b0a284 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"1b0a284\" 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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-chevron-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Pr\u00fcfen Sie die Ger\u00e4teinformationen und den Verwendungszweck<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-chevron-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Pr\u00e4dikaten- und substanzielle \u00c4quivalenzlogik bewerten<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-chevron-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Identifizieren Sie L\u00fccken in der Dokumentation, den Tests und der Kennzeichnung<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-chevron-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zm113.9 231L234.4 103.5c-9.4-9.4-24.6-9.4-33.9 0l-17 17c-9.4 9.4-9.4 24.6 0 33.9L285.1 256 183.5 357.6c-9.4 9.4-9.4 24.6 0 33.9l17 17c9.4 9.4 24.6 9.4 33.9 0L369.9 273c9.4-9.4 9.4-24.6 0-34z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Definieren Sie praktische n\u00e4chste Schritte vor der Einreichung<\/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 class=\"elementor-element elementor-element-67d7bb1 elementor-align-left borda-piscando elementor-mobile-align-left elementor-widget elementor-widget-button\" data-id=\"67d7bb1\" 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-pulse\" href=\"#cta\">\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\">Planen Sie eine kostenlose \u00dcberpr\u00fcfung<\/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<div class=\"elementor-element elementor-element-43c0194 e-con-full e-flex e-con e-child\" data-id=\"43c0194\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c62bed2 elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-widget elementor-widget-image\" data-id=\"c62bed2\" 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=\"951\" height=\"960\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/FDA-registration.jpg\" class=\"attachment-full size-full wp-image-36097\" alt=\"FDA registration of Medical Devices or Cosmetics\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/FDA-registration.jpg 951w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/FDA-registration-297x300.jpg 297w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/FDA-registration-150x150.jpg 150w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/FDA-registration-768x775.jpg 768w\" sizes=\"(max-width: 951px) 100vw, 951px\" \/>\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>\n\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-79f04d4 e-con-full e-flex e-con e-parent\" data-id=\"79f04d4\" 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-a4daf92 e-con-full e-flex e-con e-child\" data-id=\"a4daf92\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ce13233 elementor-widget elementor-widget-heading\" data-id=\"ce13233\" 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\">Was Sie erhalten<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a4cc7cf elementor-widget elementor-widget-text-editor\" data-id=\"a4cc7cf\" 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\":\"Your deliverables are designed to make the 510(k) logic easier to review, organize and defend internally.\"}]\" data-inline-monday=\"true\">Ihre Ergebnisse sollen die 510(k)-Logik leichter \u00fcberpr\u00fcfen, organisieren und intern verteidigen lassen.<\/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-f09375c e-flex e-con-boxed e-con e-child\" data-id=\"f09375c\" 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-1777996 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"1777996\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeIn&quot;,&quot;animation_delay&quot;:10}\">\n\t\t<div class=\"elementor-element elementor-element-9cd140f e-con-full e-flex e-con e-child\" data-id=\"9cd140f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-152fa03 elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"152fa03\" 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=\"458\" height=\"458\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/One-Navy-Blue.webp\" class=\"attachment-large size-large wp-image-36070\" alt=\"One - Navy Blue\" \/>\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-ce0e2fe e-con-full e-flex e-con e-child\" data-id=\"ce0e2fe\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ead82ef elementor-widget elementor-widget-heading\" data-id=\"ead82ef\" 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\">Produkt- &amp; Routen\u00fcbersicht<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b8173ce elementor-widget elementor-widget-text-editor\" data-id=\"b8173ce\" 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\":\"Clarify the path before building the file.\"}]\" data-inline-monday=\"true\">Kl\u00e4ren Sie den 510(k)-Pfad, die Positionierung des Produkts, den Verwendungszweck und den Weg der Regulierung.<\/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 class=\"elementor-element elementor-element-18cf318 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"18cf318\" 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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Bewertung von Kandidatenpr\u00e4dikaten<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Empfohlene 510(k) Route<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Begr\u00fcndung f\u00fcr den gew\u00e4hlten Weg<\/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<div class=\"elementor-element elementor-element-4e64fe5 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"4e64fe5\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeIn&quot;,&quot;animation_delay&quot;:5}\">\n\t\t<div class=\"elementor-element elementor-element-2b5d4f4 e-con-full e-flex e-con e-child\" data-id=\"2b5d4f4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-b63522b e-con-full e-flex e-con e-child\" data-id=\"b63522b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a555fbd elementor-widget elementor-widget-heading\" data-id=\"a555fbd\" 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\">Pr\u00e4dikat &amp; Anspruchspr\u00fcfung<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2b8ad58 elementor-widget elementor-widget-text-editor\" data-id=\"2b8ad58\" 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>\u00dcberpr\u00fcfen Sie die Pr\u00e4dikatenlogik, die Gr\u00fcnde f\u00fcr die substanzielle \u00c4quivalenz, die Anspr\u00fcche und die Konsistenz der Beschriftung.<\/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-6f6678a elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"6f6678a\" 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=\"458\" height=\"458\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/Two-Navy-Blue.webp\" class=\"attachment-large size-large wp-image-36064\" alt=\"Two - Navy Blue\" \/>\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-1357691 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"1357691\" 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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Verwendungszweck und Indikationen im Vergleich<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Vergleich der technologischen Merkmale<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Etikettierung und Anpassung der Anspr\u00fcche<\/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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-50984ae e-flex e-con-boxed e-con e-child\" data-id=\"50984ae\" 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-aadd52b e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"aadd52b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeIn&quot;,&quot;animation_delay&quot;:10}\">\n\t\t<div class=\"elementor-element elementor-element-c912a51 e-con-full e-flex e-con e-child\" data-id=\"c912a51\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-34d87ee e-con-full e-flex e-con e-child\" data-id=\"34d87ee\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ae01847 elementor-widget elementor-widget-heading\" data-id=\"ae01847\" 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\">\u00dcberpr\u00fcfung der Evidenzl\u00fccken<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d37b5e0 elementor-widget elementor-widget-text-editor\" data-id=\"d37b5e0\" 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 contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"attributes\":{\"bold\":true},\"insert\":\"Show how your data supports the SE rationale.\"}]\" data-inline-monday=\"true\">Erkennen Sie fehlende, unzureichende oder inkonsistente Dokumentation, bevor die FDA Fragen stellt.<\/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-a066eab elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"a066eab\" 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=\"458\" height=\"458\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/Three-Navy-Blue.webp\" class=\"attachment-large size-large wp-image-36058\" alt=\"Three - Navy Blue\" \/>\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-ed5a4d7 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"ed5a4d7\" 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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Beweise, die Behauptungen und SE-Fragen zugeordnet sind<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Anwendbare Normen und Testerwartungen<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Identifizierung von L\u00fccken vor der Einreichung<\/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<div class=\"elementor-element elementor-element-6d201ae e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"6d201ae\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeIn&quot;,&quot;animation_delay&quot;:5}\">\n\t\t<div class=\"elementor-element elementor-element-83abb40 e-con-full e-flex e-con e-child\" data-id=\"83abb40\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-e370e67 e-con-full e-flex e-con e-child\" data-id=\"e370e67\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b894afc elementor-widget elementor-widget-heading\" data-id=\"b894afc\" 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\">Einreichungspaket Bereitschaft<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6fbbdda elementor-widget elementor-widget-text-editor\" data-id=\"6fbbdda\" 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 erhalten klare n\u00e4chste Schritte, um Ihre 510(k)-Vorbereitung zu vervollst\u00e4ndigen, zu korrigieren oder zu verbessern.<\/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-63441aa elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"63441aa\" 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=\"458\" height=\"458\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/Four-Navy-Blue.webp\" class=\"attachment-large size-large wp-image-36052\" alt=\"Four - Navy Blue\" \/>\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-0a93731 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"0a93731\" 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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Inhalt nach eSTAR-Abschnitten geordnet<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Checkliste f\u00fcr die Abnahme vor dem Flug<\/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\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">\u00dcbergabepaket f\u00fcr Ihren regulatorischen Eigent\u00fcmer<\/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\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6aee21a e-con-full e-flex e-con e-parent\" data-id=\"6aee21a\" 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-7f64fe0 e-con-full e-flex e-con e-child\" data-id=\"7f64fe0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5fb4f96 elementor-widget elementor-widget-heading\" data-id=\"5fb4f96\" 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\">Einfache und strukturierte 510(k)-Vorbereitung<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a2dd157 elementor-widget elementor-widget-text-editor\" data-id=\"a2dd157\" 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\":\"A clear workflow helps your team reduce uncertainty before the submission is assembled.\"}]\" data-inline-monday=\"true\">Ein klarer Arbeitsablauf hilft Ihrem Team, Unsicherheiten zu verringern, bevor die Vorlage zusammengestellt wird.<\/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-4f95445 e-con-full process-timeline e-flex e-con e-child\" data-id=\"4f95445\" 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-8df169b e-con-full proc-item e-flex e-con e-child\" data-id=\"8df169b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-51c0f02 elementor-widget elementor-widget-heading\" data-id=\"51c0f02\" 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\">1<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f92da05 proc-icon elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"f92da05\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\" icon_cloud-upload_alt\"><\/i>\t\t\t<\/div>\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-0b8a733 proc-text elementor-widget elementor-widget-text-editor\" data-id=\"0b8a733\" 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><strong>Sie teilen Ihre Ger\u00e4teinformationen<\/strong><\/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-a25ed13 elementor-widget elementor-widget-text-editor\" data-id=\"a25ed13\" 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>Senden Sie verf\u00fcgbare Dokumentation, Verwendungszweck, Anspr\u00fcche, Kennzeichnung, Tests und Produktdetails<\/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-59afe58 e-con-full proc-item e-flex e-con e-child\" data-id=\"59afe58\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9fe9992 elementor-widget elementor-widget-heading\" data-id=\"9fe9992\" 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\">2<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4656f40 proc-icon elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"4656f40\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\" icon_folder-alt\"><\/i>\t\t\t<\/div>\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-0f0826c proc-text elementor-widget elementor-widget-text-editor\" data-id=\"0f0826c\" 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><strong>Wir bewerten Ihre 510(k)-Position:<\/strong><\/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-5e02d78 elementor-widget elementor-widget-text-editor\" data-id=\"5e02d78\" 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>Wir \u00fcberpr\u00fcfen Ihren Weg, die Pr\u00e4dikatsstrategie und die substanzielle \u00c4quivalenzlogik<\/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-060b507 e-con-full proc-item e-flex e-con e-child\" data-id=\"060b507\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9db19a8 elementor-widget elementor-widget-heading\" data-id=\"9db19a8\" 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\">3<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5ce77e6 proc-icon elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"5ce77e6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-check-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 48c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m140.204 130.267l-22.536-22.718c-4.667-4.705-12.265-4.736-16.97-.068L215.346 303.697l-59.792-60.277c-4.667-4.705-12.265-4.736-16.97-.069l-22.719 22.536c-4.705 4.667-4.736 12.265-.068 16.971l90.781 91.516c4.667 4.705 12.265 4.736 16.97.068l172.589-171.204c4.704-4.668 4.734-12.266.067-16.971z\"><\/path><\/svg>\t\t\t<\/div>\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-31d7528 proc-text elementor-widget elementor-widget-text-editor\" data-id=\"31d7528\" 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><strong>Wir identifizieren die wichtigsten Risiken:<\/strong><\/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-dac9431 elementor-widget elementor-widget-text-editor\" data-id=\"dac9431\" 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>Wir weisen auf Dokumentations-, Beweis-, Kennzeichnungs- oder Testl\u00fccken hin, die Fragen der FDA aufwerfen k\u00f6nnten.<\/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-988a068 e-con-full proc-item e-flex e-con e-child\" data-id=\"988a068\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1671212 elementor-widget elementor-widget-heading\" data-id=\"1671212\" 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\">4<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-62811ad proc-icon elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"62811ad\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\" icon_pencil-edit\"><\/i>\t\t\t<\/div>\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-08aa6d8 proc-text elementor-widget elementor-widget-text-editor\" data-id=\"08aa6d8\" 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><strong>Wir organisieren die n\u00e4chsten Schritte:<\/strong><\/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-e6516ef elementor-widget elementor-widget-text-editor\" data-id=\"e6516ef\" 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 erhalten einen strukturierten \u00dcberblick dar\u00fcber, was korrigiert, erg\u00e4nzt oder gekl\u00e4rt werden muss.<\/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-915fa81 e-con-full proc-item e-flex e-con e-child\" data-id=\"915fa81\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d3789f7 elementor-widget elementor-widget-heading\" data-id=\"d3789f7\" 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\">5<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-612baac proc-icon elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"612baac\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-clipboard-check\" viewBox=\"0 0 384 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M336 64h-80c0-35.3-28.7-64-64-64s-64 28.7-64 64H48C21.5 64 0 85.5 0 112v352c0 26.5 21.5 48 48 48h288c26.5 0 48-21.5 48-48V112c0-26.5-21.5-48-48-48zM192 40c13.3 0 24 10.7 24 24s-10.7 24-24 24-24-10.7-24-24 10.7-24 24-24zm121.2 231.8l-143 141.8c-4.7 4.7-12.3 4.6-17-.1l-82.6-83.3c-4.7-4.7-4.6-12.3.1-17L99.1 285c4.7-4.7 12.3-4.6 17 .1l46 46.4 106-105.2c4.7-4.7 12.3-4.6 17 .1l28.2 28.4c4.7 4.8 4.6 12.3-.1 17z\"><\/path><\/svg>\t\t\t<\/div>\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-cfdcb37 proc-text elementor-widget elementor-widget-text-editor\" data-id=\"cfdcb37\" 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><strong>Sie gehen mit Zuversicht voran:<\/strong><\/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-97da40c elementor-widget elementor-widget-text-editor\" data-id=\"97da40c\" 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 Team erh\u00e4lt die Dokumentation, die Notizen und die \u00dcbergabe, die zum Fortfahren erforderlich sind.<\/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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d31e2ed e-flex e-con-boxed e-con e-parent\" data-id=\"d31e2ed\" 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-3e28b45 e-con-full e-flex e-con e-child\" data-id=\"3e28b45\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c7b4c25 elementor-widget elementor-widget-heading\" data-id=\"c7b4c25\" 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\">Warum Unternehmen Sobel vor der FDA-Einreichung w\u00e4hlen\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-15070ae elementor-widget elementor-widget-text-editor\" data-id=\"15070ae\" 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 510(k) support built around predicate strategy, substantial equivalence and eSTAR readiness.\"}]\" data-inline-monday=\"true\">Spezialisierte Unterst\u00fctzung f\u00fcr Unternehmen bei der Vorbereitung der 510(k)-Dokumentation, der FDA-Strategie und der Markteinf\u00fchrung in den USA.<\/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-fb10006 e-con-full e-flex e-con e-child\" data-id=\"fb10006\" 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-e0c9bc1 e-con-full e-flex e-con e-child\" data-id=\"e0c9bc1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-5cb9e61 e-con-full e-flex e-con e-child\" data-id=\"5cb9e61\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dcc5884 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"dcc5884\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-clipboard-list\" viewBox=\"0 0 384 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M336 64h-80c0-35.3-28.7-64-64-64s-64 28.7-64 64H48C21.5 64 0 85.5 0 112v352c0 26.5 21.5 48 48 48h288c26.5 0 48-21.5 48-48V112c0-26.5-21.5-48-48-48zM96 424c-13.3 0-24-10.7-24-24s10.7-24 24-24 24 10.7 24 24-10.7 24-24 24zm0-96c-13.3 0-24-10.7-24-24s10.7-24 24-24 24 10.7 24 24-10.7 24-24 24zm0-96c-13.3 0-24-10.7-24-24s10.7-24 24-24 24 10.7 24 24-10.7 24-24 24zm96-192c13.3 0 24 10.7 24 24s-10.7 24-24 24-24-10.7-24-24 10.7-24 24-24zm128 368c0 4.4-3.6 8-8 8H168c-4.4 0-8-3.6-8-8v-16c0-4.4 3.6-8 8-8h144c4.4 0 8 3.6 8 8v16zm0-96c0 4.4-3.6 8-8 8H168c-4.4 0-8-3.6-8-8v-16c0-4.4 3.6-8 8-8h144c4.4 0 8 3.6 8 8v16zm0-96c0 4.4-3.6 8-8 8H168c-4.4 0-8-3.6-8-8v-16c0-4.4 3.6-8 8-8h144c4.4 0 8 3.6 8 8v16z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ed6b7f1 e-con-full e-flex e-con e-child\" data-id=\"ed6b7f1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dd3f8e9 elementor-widget elementor-widget-heading\" data-id=\"dd3f8e9\" 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\">Reduzieren Sie vermeidbare Nacharbeit<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d627da2 elementor-widget elementor-widget-text-editor\" data-id=\"d627da2\" 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>Wir helfen Ihnen, L\u00fccken in den Vorschriften und der Dokumentation zu erkennen, bevor sie zu kostspieligen Verz\u00f6gerungen 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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6dc484e e-con-full e-flex e-con e-child\" data-id=\"6dc484e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e2e538a elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"e2e538a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-globe-americas\" viewBox=\"0 0 496 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M248 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6.61 10.69l11.08 5.54c9.41 4.71 19.79 7.16 30.31 7.16s22.59 27.29 32 32h66.75c8.49 0 16.62 3.37 22.63 9.37l13.69 13.69a30.503 30.503 0 0 1 8.93 21.57 46.536 46.536 0 0 1-13.72 32.98zM417 274.25c-5.79-1.45-10.84-5-14.15-9.97l-17.98-26.97a23.97 23.97 0 0 1 0-26.62l19.59-29.38c2.32-3.47 5.5-6.29 9.24-8.15l12.98-6.49C440.2 193.59 448 223.87 448 256c0 8.67-.74 17.16-1.82 25.54L417 274.25z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-24b5ec1 e-con-full e-flex e-con e-child\" data-id=\"24b5ec1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e314393 elementor-widget elementor-widget-heading\" data-id=\"e314393\" 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 f\u00fcr internationale Unternehmen<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-146560a elementor-widget elementor-widget-text-editor\" data-id=\"146560a\" 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\":\"We translate test data, labeling, claims and technology differences into clear regulatory arguments.\"}]\" data-inline-monday=\"true\">Wir beraten ausl\u00e4ndische Hersteller, die sich auf den US-Markt f\u00fcr Medizinprodukte vorbereiten.<\/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<div class=\"elementor-element elementor-element-fe354c0 e-con-full e-flex e-con e-child\" data-id=\"fe354c0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e56eda7 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"e56eda7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-clipboard-check\" viewBox=\"0 0 384 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M336 64h-80c0-35.3-28.7-64-64-64s-64 28.7-64 64H48C21.5 64 0 85.5 0 112v352c0 26.5 21.5 48 48 48h288c26.5 0 48-21.5 48-48V112c0-26.5-21.5-48-48-48zM192 40c13.3 0 24 10.7 24 24s-10.7 24-24 24-24-10.7-24-24 10.7-24 24-24zm121.2 231.8l-143 141.8c-4.7 4.7-12.3 4.6-17-.1l-82.6-83.3c-4.7-4.7-4.6-12.3.1-17L99.1 285c4.7-4.7 12.3-4.6 17 .1l46 46.4 106-105.2c4.7-4.7 12.3-4.6 17 .1l28.2 28.4c4.7 4.8 4.6 12.3-.1 17z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4f1dff0 e-con-full e-flex e-con e-child\" data-id=\"4f1dff0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a2810c5 elementor-widget elementor-widget-heading\" data-id=\"a2810c5\" 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\">Strategie \u00fcber die Zusammenstellung von Dokumenten hinaus<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a26c0fd elementor-widget elementor-widget-text-editor\" data-id=\"a26c0fd\" 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\":\"We structure content around the format, prompts and acceptance logic FDA expects.\"}]\" data-inline-monday=\"true\">Unsere Pr\u00fcfung verbindet Verwendungszweck, Pr\u00e4dikatenlogik, Beweise, Kennzeichnung und Einreichungsbereitschaft.<\/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<div class=\"elementor-element elementor-element-ecae8e2 e-con-full e-flex e-con e-child\" data-id=\"ecae8e2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-69c239b elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"69c239b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-route\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 320h-96c-17.6 0-32-14.4-32-32s14.4-32 32-32h96s96-107 96-160-43-96-96-96-96 43-96 96c0 25.5 22.2 63.4 45.3 96H320c-52.9 0-96 43.1-96 96s43.1 96 96 96h96c17.6 0 32 14.4 32 32s-14.4 32-32 32H185.5c-16 24.8-33.8 47.7-47.3 64H416c52.9 0 96-43.1 96-96s-43.1-96-96-96zm0-256c17.7 0 32 14.3 32 32s-14.3 32-32 32-32-14.3-32-32 14.3-32 32-32zM96 256c-53 0-96 43-96 96s96 160 96 160 96-107 96-160-43-96-96-96zm0 128c-17.7 0-32-14.3-32-32s14.3-32 32-32 32 14.3 32 32-14.3 32-32 32z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-31c11c8 e-con-full e-flex e-con e-child\" data-id=\"31c11c8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5628aad elementor-widget elementor-widget-heading\" data-id=\"5628aad\" 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\">Klare regulatorische n\u00e4chste Schritte<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8506f6c elementor-widget elementor-widget-text-editor\" data-id=\"8506f6c\" 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\":\"We help internal teams align before submission, reducing confusion and rework.\"}]\" data-inline-monday=\"true\">Ihr Team erh\u00e4lt praktische Anweisungen, bevor es mit der FDA-Pr\u00fcfung fortf\u00e4hrt.<\/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-97a7a33 e-con-full e-flex e-con e-child\" data-id=\"97a7a33\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6b675f5 elementor-widget elementor-widget-image\" data-id=\"6b675f5\" 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=\"800\" height=\"673\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/FDA-package-1024x861.jpg\" class=\"attachment-large size-large wp-image-36103\" alt=\"FDA package 510k\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/FDA-package-1024x861.jpg 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/FDA-package-300x252.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/FDA-package-768x645.jpg 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/FDA-package.jpg 1090w\" 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\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-985288e e-con-full e-flex e-con e-parent\" data-id=\"985288e\" data-element_type=\"container\" data-e-type=\"container\" id=\"cta\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-b872097 e-con-full e-flex e-con e-child\" data-id=\"b872097\" 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-0e31680 e-con-full e-flex e-con e-child\" data-id=\"0e31680\" 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-0141445 e-con-full e-flex e-con e-child\" data-id=\"0141445\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-54ad9f3 elementor-widget elementor-widget-heading\" data-id=\"54ad9f3\" 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<h1 class=\"elementor-heading-title elementor-size-default\">Pr\u00fcfen Sie Ihre 510(k) Bereitschaft\n<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-18d55a8 elementor-widget elementor-widget-heading\" data-id=\"18d55a8\" 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\">Erz\u00e4hlen Sie uns von Ihrem Ger\u00e4t, der aktuellen Dokumentation und dem Ziel der FDA-Markteinf\u00fchrung. Sobel wird pr\u00fcfen, wie wir Sie bei Ihrem n\u00e4chsten Schritt unterst\u00fctzen k\u00f6nnen. \n<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fcd05a7 form-check-icon elementor-icon-list--layout-inline elementor-align-center elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"fcd05a7\" 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 elementor-inline-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-inline-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Klare n\u00e4chste Schritte<\/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 elementor-inline-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Unverbindlich<\/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 elementor-inline-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\" icon_check_alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Fachliche \u00dcberpr\u00fcfung<\/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 class=\"elementor-element elementor-element-653eecf elementor-widget__width-initial elementor-button-align-stretch elementor-widget elementor-widget-form\" data-id=\"653eecf\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;step_next_label&quot;:&quot;N\\u00e4chste&quot;,&quot;step_previous_label&quot;:&quot;Vorherige&quot;,&quot;button_width&quot;:&quot;100&quot;,&quot;step_type&quot;:&quot;number_text&quot;,&quot;step_icon_shape&quot;:&quot;circle&quot;}\" data-widget_type=\"form.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<form class=\"elementor-form\" method=\"post\" id=\"form_lp_eu_cpsr_eng\" name=\"Kontakt-Formular - 510k\" aria-label=\"Kontakt-Formular - 510k\">\n\t\t\t<input type=\"hidden\" name=\"post_id\" value=\"34945\"\/>\n\t\t\t<input type=\"hidden\" name=\"form_id\" value=\"653eecf\"\/>\n\t\t\t<input type=\"hidden\" name=\"referer_title\" value=\"Sobel\" \/>\n\n\t\t\t\n\t\t\t<div class=\"elementor-form-fields-wrapper elementor-labels-above\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-first_name elementor-col-50 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-first_name\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tVollst\u00e4ndiger Name\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[first_name]\" id=\"form-field-first_name\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Hier tippen\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-email elementor-field-group elementor-column elementor-field-group-email elementor-col-50 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-email\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tE-Mail Adresse\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"email\" name=\"form_fields[email]\" id=\"form-field-email\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Hier tippen\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-tel elementor-field-group elementor-column elementor-field-group-phone elementor-col-50 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-phone\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tTelefon Nummer\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t<input size=\"1\" type=\"tel\" name=\"form_fields[phone]\" id=\"form-field-phone\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Hier tippen\" required=\"required\" pattern=\"[0-9()#&amp;+*-=.]+\" title=\"Nur Nummern oder Telefon-Zeichen (#, -, *, etc) werden akzeptiert.\">\n\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-company elementor-col-50 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-company\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tUnternehmen\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[company]\" id=\"form-field-company\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Hier tippen\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-select elementor-field-group elementor-column elementor-field-group-business_area elementor-col-100 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-business_area\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tGesch\u00e4ftsfeld\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field elementor-select-wrapper remove-before \">\n\t\t\t<div class=\"select-caret-down-wrapper\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-eicon-caret-down\" viewBox=\"0 0 571.4 571.4\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M571 393Q571 407 561 418L311 668Q300 679 286 679T261 668L11 418Q0 407 0 393T11 368 36 357H536Q550 357 561 368T571 393Z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t\t<select name=\"form_fields[business_area]\" id=\"form-field-business_area\" class=\"elementor-field-textual elementor-size-sm\" required=\"required\">\n\t\t\t\t\t\t\t\t\t<option value=\"\">Bitte w\u00e4hlen Sie eine Option <\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Medizinprodukte\">Medizinprodukte<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Kosmetika\">Kosmetika<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"In-vitro-Diagnostik\">In-vitro-Diagnostik<\/option>\n\t\t\t\t\t\t\t<\/select>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-textarea elementor-field-group elementor-column elementor-field-group-message elementor-col-100 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-message\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tNachricht\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t<textarea class=\"elementor-field-textual elementor-field  elementor-size-sm\" name=\"form_fields[message]\" id=\"form-field-message\" rows=\"4\" placeholder=\"Hier tippen\" required=\"required\"><\/textarea>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-acceptance elementor-field-group elementor-column elementor-field-group-privacyagreed elementor-col-100 elementor-field-required elementor-mark-required\">\n\t\t\t\t\t\t\t<div class=\"elementor-field-subgroup\">\n\t\t\t<span class=\"elementor-field-option\">\n\t\t\t\t<input type=\"checkbox\" name=\"form_fields[privacyagreed]\" id=\"form-field-privacyagreed\" class=\"elementor-field elementor-size-sm  elementor-acceptance-field\" required=\"required\">\n\t\t\t\t<label for=\"form-field-privacyagreed\">&nbsp;&nbsp;  Ich stimme der Datenschutzerkl\u00e4rung und den auf dieser Website ver\u00f6ffentlichten Bedingungen zu.<\/label>\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-acceptance elementor-field-group elementor-column elementor-field-group-newslettercheck elementor-col-100\">\n\t\t\t\t\t\t\t<div class=\"elementor-field-subgroup\">\n\t\t\t<span class=\"elementor-field-option\">\n\t\t\t\t<input type=\"checkbox\" name=\"form_fields[newslettercheck]\" id=\"form-field-newslettercheck\" class=\"elementor-field elementor-size-sm  elementor-acceptance-field\">\n\t\t\t\t<label for=\"form-field-newslettercheck\">&nbsp; &nbsp;Ich bin damit einverstanden, zweiw\u00f6chentlich einen Newsletter mit aktuellen Informationen \u00fcber den globalen Regulierungsmarkt zu erhalten.<\/label>\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_source elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_source]\" id=\"form-field-utm_source\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_campaign elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_campaign]\" id=\"form-field-utm_campaign\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_adgroupname elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_adgroupname]\" id=\"form-field-utm_adgroupname\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_term elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_term]\" id=\"form-field-utm_term\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-gclid elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[gclid]\" id=\"form-field-gclid\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_content elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_content]\" id=\"form-field-utm_content\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-utm_device elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[utm_device]\" id=\"form-field-utm_device\" class=\"elementor-field elementor-size-sm  elementor-field-textual\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-group elementor-column elementor-field-type-submit elementor-col-100 e-form__buttons\">\n\t\t\t\t\t<button class=\"elementor-button elementor-size-sm\" type=\"submit\" id=\"btn_eu_cpsr_eng\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Meine 510(k)-Pr\u00fcfung anfordern<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/button>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/form>\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-74773bf elementor-widget elementor-widget-html\" data-id=\"74773bf\" 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<link rel=\"stylesheet\" href=\"https:\/\/cdnjs.cloudflare.com\/ajax\/libs\/intl-tel-input\/17.0.8\/css\/intlTelInput.css\">\r\n\r\n<script src=\"https:\/\/cdnjs.cloudflare.com\/ajax\/libs\/intl-tel-input\/17.0.8\/js\/intlTelInput.min.js\"><\/script>\r\n\r\n<script>\r\ndocument.addEventListener(\"DOMContentLoaded\", function () {\r\n  const phoneInputs = document.querySelectorAll('input[type=\"tel\"]');\r\n\r\n  phoneInputs.forEach(function (input) {\r\n    \/\/ Prevent duplicate initialization\r\n    if (input.dataset.itiInitialized === \"true\") {\r\n      return;\r\n    }\r\n\r\n    \/\/ Also skip if Elementor \/ another script already wrapped it\r\n    if (input.closest(\".iti\")) {\r\n      return;\r\n    }\r\n\r\n    input.dataset.itiInitialized = \"true\";\r\n\r\n    \/\/ Improve mobile keyboard\r\n    input.setAttribute(\"inputmode\", \"numeric\");\r\n    input.setAttribute(\"pattern\", \"[0-9]*\");\r\n\r\n    \/\/ Allow only numbers in the visible phone field\r\n    input.addEventListener(\"input\", function () {\r\n      input.value = input.value.replace(\/\\D\/g, \"\");\r\n    });\r\n\r\n    const iti = window.intlTelInput(input, {\r\n      separateDialCode: true,\r\n      preferredCountries: [\"br\", \"us\", \"de\", \"fr\"],\r\n      initialCountry: \"br\",\r\n      hiddenInput: \"full\",\r\n      utilsScript:\r\n        \"https:\/\/cdnjs.cloudflare.com\/ajax\/libs\/intl-tel-input\/17.0.8\/js\/utils.js\"\r\n    });\r\n\r\n    const form = input.closest(\"form\");\r\n\r\n    if (!form) {\r\n      return;\r\n    }\r\n\r\n    form.addEventListener(\"submit\", function (event) {\r\n      \/\/ Clean again before submit\r\n      input.value = input.value.replace(\/\\D\/g, \"\");\r\n\r\n      if (!iti.isValidNumber()) {\r\n        event.preventDefault();\r\n        alert(\"Please enter a valid phone number.\");\r\n        input.focus();\r\n        return;\r\n      }\r\n\r\n      input.value = iti.getNumber();\r\n    });\r\n  });\r\n});\r\n<\/script>\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-4ce9a22 e-flex e-con-boxed e-con e-parent\" data-id=\"4ce9a22\" 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-dceec13 e-con-full e-flex e-con e-child\" data-id=\"dceec13\" 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-9c01286 elementor-widget elementor-widget-heading\" data-id=\"9c01286\" 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\">H\u00e4ufig gestellte Fragen<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-dfea964 elementor-widget elementor-widget-toggle\" data-id=\"dfea964\" 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-2341\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-2341\" 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-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M31.3 192h257.3c17.8 0 26.7 21.5 14.1 34.1L174.1 354.8c-7.8 7.8-20.5 7.8-28.3 0L17.2 226.1C4.6 213.5 13.5 192 31.3 192z\"><\/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\">F\u00fcr welche Art von Unternehmen ist dieser Service gedacht?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2341\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-2341\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"The best time is before the 510(k) package is fully assembled, especially if route, predicate, claims, evidence or eSTAR structure are still uncertain.\"}]\" data-inline-monday=\"true\">Diese Unterst\u00fctzung eignet sich am besten f\u00fcr Medizinprodukteunternehmen mit einem definierten Produkt, einer in Arbeit befindlichen Dokumentation und einem Plan, in den US-Markt einzutreten oder dort t\u00e4tig zu werden.<\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2342\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-2342\" 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-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M31.3 192h257.3c17.8 0 26.7 21.5 14.1 34.1L174.1 354.8c-7.8 7.8-20.5 7.8-28.3 0L17.2 226.1C4.6 213.5 13.5 192 31.3 192z\"><\/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\">M\u00fcssen wir zur Abgabe bereit sein?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2342\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-2342\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"That is a common starting point. Sobel helps evaluate candidate predicates and organize the rationale for the option that best supports your substantial equivalence case.\"}]\" data-inline-monday=\"true\">Nein. Sobel kann Unternehmen vor der Einreichung unterst\u00fctzen, indem er den Weg, die Dokumentationsl\u00fccken, die Pr\u00e4dikatsstrategie und die Bereitschaftsrisiken pr\u00fcft. <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2343\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-2343\" 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-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M31.3 192h257.3c17.8 0 26.7 21.5 14.1 34.1L174.1 354.8c-7.8 7.8-20.5 7.8-28.3 0L17.2 226.1C4.6 213.5 13.5 192 31.3 192z\"><\/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\">Kann Sobel helfen, wenn wir uns nicht sicher sind, ob wir den richtigen Weg zur FDA eingeschlagen haben?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2343\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-2343\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"The right route depends on your device, predicate, intended use, technological differences and available evidence. We help assess whether a Traditional, Special or Safety &#038; Performance Based 510(k) is the most appropriate path.\"}]\" data-inline-monday=\"true\">Ja. Wir k\u00f6nnen die Informationen zu Ihrem Ger\u00e4t, die beabsichtigte Verwendung und die regulatorische Position \u00fcberpr\u00fcfen, um die am besten geeigneten n\u00e4chsten Schritte zu kl\u00e4ren. <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2344\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-2344\" 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-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M31.3 192h257.3c17.8 0 26.7 21.5 14.1 34.1L174.1 354.8c-7.8 7.8-20.5 7.8-28.3 0L17.2 226.1C4.6 213.5 13.5 192 31.3 192z\"><\/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\">Ist dies eine Vorlage, ein Kurs oder ein DIY 510(k) Leitfaden?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2344\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-2344\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"We review the logic before the file is finalized, align claims with evidence, organize comparison tables and check whether eSTAR and RTA expectations have been addressed.\"}]\" data-inline-monday=\"true\">Nein. Es handelt sich um professionelle regulatorische Unterst\u00fctzung f\u00fcr Unternehmen, die ein echtes Medizinprodukt f\u00fcr die Pr\u00fcfung durch die FDA vorbereiten. <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2345\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-2345\" 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-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M31.3 192h257.3c17.8 0 26.7 21.5 14.1 34.1L174.1 354.8c-7.8 7.8-20.5 7.8-28.3 0L17.2 226.1C4.6 213.5 13.5 192 31.3 192z\"><\/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\">Kann Sobel ausl\u00e4ndischen Herstellern beim Eintritt in den US-Markt helfen?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2345\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-2345\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Yes. We can review the current structure, identify weak points in the SE rationale and help organize the content into a clearer eSTAR-ready package.\"}]\" data-inline-monday=\"true\">Ja. Sobel unterst\u00fctzt internationale Unternehmen bei der FDA-Regulierungsstrategie, der \u00dcberpr\u00fcfung der Dokumentation, der Registrierung, der Listung und der Planung des Markteintritts. <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2346\" class=\"elementor-tab-title\" data-tab=\"6\" role=\"button\" aria-controls=\"elementor-tab-content-2346\" 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-down\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M31.3 192h257.3c17.8 0 26.7 21.5 14.1 34.1L174.1 354.8c-7.8 7.8-20.5 7.8-28.3 0L17.2 226.1C4.6 213.5 13.5 192 31.3 192z\"><\/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\">Was sollten wir haben, bevor wir Sobel kontaktieren?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2346\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"6\" role=\"region\" aria-labelledby=\"elementor-tab-title-2346\"><p>Im Idealfall haben Sie ein definiertes Produkt, einen Verwendungszweck, einen Zielmarkt, Herstellerinformationen und zumindest einige technische oder regulatorische Unterlagen.<\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t<script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"F\\u00fcr welche Art von Unternehmen ist dieser Service gedacht?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p class=\\\"monday-block-1\\\" contenteditable=\\\"true\\\" data-monday-block-type=\\\"1\\\" data-monday-block-content=\\\"[{\\\"insert\\\":\\\"The best time is before the 510(k) package is fully assembled, especially if route, predicate, claims, evidence or eSTAR structure are still uncertain.\\\"}]\\\" data-inline-monday=\\\"true\\\">Diese Unterst\\u00fctzung eignet sich am besten f\\u00fcr Medizinprodukteunternehmen mit einem definierten Produkt, einer in Arbeit befindlichen Dokumentation und einem Plan, in den US-Markt einzutreten oder dort t\\u00e4tig zu werden.<\\\/p>\\n\"}},{\"@type\":\"Question\",\"name\":\"M\\u00fcssen wir zur Abgabe bereit sein?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p class=\\\"monday-block-1\\\" contenteditable=\\\"true\\\" data-monday-block-type=\\\"1\\\" data-monday-block-content=\\\"[{\\\"insert\\\":\\\"That is a common starting point. Sobel helps evaluate candidate predicates and organize the rationale for the option that best supports your substantial equivalence case.\\\"}]\\\" data-inline-monday=\\\"true\\\">Nein. Sobel kann Unternehmen vor der Einreichung unterst\\u00fctzen, indem er den Weg, die Dokumentationsl\\u00fccken, die Pr\\u00e4dikatsstrategie und die Bereitschaftsrisiken pr\\u00fcft. <\\\/p>\\n\"}},{\"@type\":\"Question\",\"name\":\"Kann Sobel helfen, wenn wir uns nicht sicher sind, ob wir den richtigen Weg zur FDA eingeschlagen haben?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p class=\\\"monday-block-1\\\" contenteditable=\\\"true\\\" data-monday-block-type=\\\"1\\\" data-monday-block-content=\\\"[{\\\"insert\\\":\\\"The right route depends on your device, predicate, intended use, technological differences and available evidence. We help assess whether a Traditional, Special or Safety &#038; Performance Based 510(k) is the most appropriate path.\\\"}]\\\" data-inline-monday=\\\"true\\\">Ja. Wir k\\u00f6nnen die Informationen zu Ihrem Ger\\u00e4t, die beabsichtigte Verwendung und die regulatorische Position \\u00fcberpr\\u00fcfen, um die am besten geeigneten n\\u00e4chsten Schritte zu kl\\u00e4ren. <\\\/p>\\n\"}},{\"@type\":\"Question\",\"name\":\"Ist dies eine Vorlage, ein Kurs oder ein DIY 510(k) Leitfaden?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p class=\\\"monday-block-1\\\" contenteditable=\\\"true\\\" data-monday-block-type=\\\"1\\\" data-monday-block-content=\\\"[{\\\"insert\\\":\\\"We review the logic before the file is finalized, align claims with evidence, organize comparison tables and check whether eSTAR and RTA expectations have been addressed.\\\"}]\\\" data-inline-monday=\\\"true\\\">Nein. Es handelt sich um professionelle regulatorische Unterst\\u00fctzung f\\u00fcr Unternehmen, die ein echtes Medizinprodukt f\\u00fcr die Pr\\u00fcfung durch die FDA vorbereiten. <\\\/p>\\n\"}},{\"@type\":\"Question\",\"name\":\"Kann Sobel ausl\\u00e4ndischen Herstellern beim Eintritt in den US-Markt helfen?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p class=\\\"monday-block-1\\\" contenteditable=\\\"true\\\" data-monday-block-type=\\\"1\\\" data-monday-block-content=\\\"[{\\\"insert\\\":\\\"Yes. We can review the current structure, identify weak points in the SE rationale and help organize the content into a clearer eSTAR-ready package.\\\"}]\\\" data-inline-monday=\\\"true\\\">Ja. Sobel unterst\\u00fctzt internationale Unternehmen bei der FDA-Regulierungsstrategie, der \\u00dcberpr\\u00fcfung der Dokumentation, der Registrierung, der Listung und der Planung des Markteintritts. <\\\/p>\\n\"}},{\"@type\":\"Question\",\"name\":\"Was sollten wir haben, bevor wir Sobel kontaktieren?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>Im Idealfall haben Sie ein definiertes Produkt, einen Verwendungszweck, einen Zielmarkt, Herstellerinformationen und zumindest einige technische oder regulatorische Unterlagen.<\\\/p>\\n\"}}]}<\/script>\n\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<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-69db787 e-flex e-con-boxed e-con e-parent\" data-id=\"69db787\" 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-eae0917 elementor-widget elementor-widget-theme-site-logo elementor-widget-image\" data-id=\"eae0917\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-site-logo.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"741\" height=\"290\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2024\/07\/Logo-Oficial-Website-White.webp\" class=\"attachment-full size-full wp-image-4520\" alt=\"Logo Sobel White\" \/>\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-055a371 elementor-widget elementor-widget-heading\" data-id=\"055a371\" 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\"><a href=\"https:\/\/sobelconsult.com\/de\/datenschutzerklaerung-br\/\" target=\"_blank\">Datenschutzpolitik<\/a><\/span>\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>Sobel hilft Medizintechnikunternehmen bei der Abstimmung von Pr\u00e4dikatsstrategie, Anspr\u00fcchen, Beweisen und eSTAR-Struktur, bevor das 510(k)-Paket eingereicht wird.<\/p>\n","protected":false},"author":16,"featured_media":0,"parent":36580,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_canvas","meta":{"_angie_page":false,"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-34945","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.8 (Yoast SEO v28.1) - 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