{"id":37346,"date":"2026-05-25T16:44:24","date_gmt":"2026-05-25T19:44:24","guid":{"rendered":"https:\/\/sobelconsult.com\/lp\/medical-devices\/lp-medical-devices-us-510k-2\/"},"modified":"2026-06-02T13:52:16","modified_gmt":"2026-06-02T16:52:16","slug":"us-510k-2-2","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/de\/lp\/medical-devices\/us-510k-2-2\/","title":{"rendered":"LP | Medizinische Ger\u00e4te | US 510(k) 2"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"37346\" class=\"elementor elementor-37346 elementor-37308\" 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\">510(k) PR\u00dcFUNG VOR DER ZULASSUNG<\/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\">Finden Sie L\u00fccken in Ihrer <span class=\"hero-blue\">510(k) <\/span><br \/>vor der \u00dcberpr\u00fcfung durch die FDA<\/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 Medizintechnikunternehmen, die einen 510(k)-Antrag vorbereiten, die Dokumentation \u00fcberpr\u00fcfen oder ihre Einreichungsstrategie bei der FDA vor der \u00dcberpr\u00fcfung validieren.<\/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 Einreichung<\/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\u00fcfung der Pr\u00e4dikaten- und substanziellen \u00c4quivalenzlogik<\/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\">Kl\u00e4ren Sie die Risiken von Tests, Kennzeichnung und Einreichung<\/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\">Bereiten Sie Ihr 510(k)-Paket mit regulatorischer Unterst\u00fctzung vor<\/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\">Beantragen Sie eine 510(k)-Pr\u00fcfung vor der Einreichung<\/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-30f1d6a elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"30f1d6a\" 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>Am besten f\u00fcr Unternehmen mit einem entwickelten Produkt, einer in Arbeit befindlichen Dokumentation oder einem definierten Plan f\u00fcr den Markteintritt 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\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\">Sie sind nicht sicher, ob Ihre 510(k) f\u00fcr die FDA-Pr\u00fcfung bereit ist?\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>Vergewissern Sie sich vor der Einreichung, dass Ihre Dokumentation, die Pr\u00e4dikatsstrategie und die Begr\u00fcndung f\u00fcr die substanzielle \u00c4quivalenz mit den Erwartungen der FDA \u00fcbereinstimmen.<\/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\">Ihr Ger\u00e4t ist definiert, aber der 510(k)-Pfad ist unklar<\/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 kann vor der Einreichung L\u00fccken aufweisen<\/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\">Ihr Pr\u00e4dikat oder Ihre SE-Begr\u00fcndung muss \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\">Ihre Kennzeichnung, Pr\u00fcfung oder beabsichtigte Verwendung kann Fragen aufwerfen<\/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>Wenn Route, Pr\u00e4dikat, Anspr\u00fcche, Beweise oder die eSTAR-Struktur noch unsicher sind, <strong>kann Sobel Ihnen dabei helfen, herauszufinden, was als n\u00e4chstes zu korrigieren, zu best\u00e4tigen oder zu organisieren ist.<\/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\">Eine vollst\u00e4ndig aussehende 510(k) kann immer noch eine schwache Logik haben<\/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>Ihre Dokumentation mag \u00fcbersichtlich aussehen, aber die Pr\u00fcfung durch die FDA h\u00e4ngt von den Gr\u00fcnden ab, die hinter dem Antrag stehen: Wahl der Route, Vergleich der Pr\u00e4dikate, beabsichtigte Verwendung, technologische Unterschiede, Behauptungen und Beweise.<\/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\">H\u00e4ufige Probleme 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-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 wird nicht eindeutig unterst\u00fctzt<\/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\">Testnachweis stimmt nicht mit Behauptungen \u00fcberein<\/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<\/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 kann Fragen der FDA ausl\u00f6sen\n<\/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\">Schwache Begr\u00fcndung 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-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\">Fehlende oder inkonsistente 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\">Unklarer Leistungs- oder Sicherheitsnachweis<\/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\">L\u00fccken zwischen Kennzeichnung, Pr\u00fcfung und bestimmungsgem\u00e4\u00dfer Verwendung<\/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\">Kl\u00e4ren Sie Ihre 510(k)-Strategie, bevor Sie weitermachen\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 Medizintechnikunternehmen bei der \u00dcberpr\u00fcfung ihres regulatorischen Weges, der Dokumentationslogik und der Einreichungsrisiken vor der \u00dcberpr\u00fcfung durch die FDA.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-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\">\u00dcberpr\u00fcfen Sie Ihr Pr\u00e4dikat und die Begr\u00fcndung der SE<\/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 und in den Nachweisen<\/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\">Kennzeichnung, Tests und Verwendungszweck aufeinander abstimmen<\/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 die n\u00e4chsten 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\">Pr\u00e4dikat &amp; Route Memo<\/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 Pfad, bevor Sie die Datei erstellen.<\/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>Stellen Sie sicher, dass Ihr Vergleich Ihre Behauptungen unterst\u00fctzt.<\/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\">Pr\u00fcfen Sie, ob Ihre Daten die Vorlage unterst\u00fctzen.<\/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 class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"attributes\":{\"bold\":true},\"insert\":\"Organize the package for acceptance review.\"}]\" data-inline-monday=\"true\">Bereiten Sie die Akte f\u00fcr eine reibungslosere \u00dcberpr\u00fcfung vor.<\/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 senden 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-d421dce elementor-widget elementor-widget-text-editor\" data-id=\"d421dce\" 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>Teilen Sie die verf\u00fcgbare Dokumentation, die Kennzeichnung, den Verwendungszweck, die Angaben und die 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 \u00fcberpr\u00fcfen Ihre regulatorische 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-6ca4c50 elementor-widget elementor-widget-text-editor\" data-id=\"6ca4c50\" 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 bewerten Ihren 510(k)-Pfad, Ihre Pr\u00e4dikatslogik und Ihre Einreichungsrisiken.<\/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 L\u00fccken<\/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-9f096d6 elementor-widget elementor-widget-text-editor\" data-id=\"9f096d6\" 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-, Test-, Kennzeichnungs- oder SE-Probleme hin, die Fragen 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-f66fb37 elementor-widget elementor-widget-text-editor\" data-id=\"f66fb37\" 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 klaren \u00dcberblick dar\u00fcber, was korrigiert oder vervollst\u00e4ndigt werden sollte, 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>\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 kommen mit mehr Klarheit 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-48507b2 elementor-widget elementor-widget-text-editor\" data-id=\"48507b2\" 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>Nutzen Sie die \u00dcberpr\u00fcfung, um Ihren Einreichungsweg mit weniger \u00dcberraschungen vorzubereiten.<\/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-con-full e-flex 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<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 f\u00fcr 510(k) Unterst\u00fctzung 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 regulatorische Unterst\u00fctzung f\u00fcr Unternehmen bei der Vorbereitung der Dokumentation, der FDA-Strategie und dem Eintritt in 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<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\">Beh\u00f6rdliche \u00dcberpr\u00fcfung vor kostspieliger 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 zu erkennen, bevor sie zu Verz\u00f6gerungen, Fragen oder Problemen bei der Wiedervorlage werden.<\/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 8C111.03 8 0 119.03 0 256s111.03 248 248 248 248-111.03 248-248S384.97 8 248 8zm82.29 357.6c-3.9 3.88-7.99 7.95-11.31 11.28-2.99 3-5.1 6.7-6.17 10.71-1.51 5.66-2.73 11.38-4.77 16.87l-17.39 46.85c-13.76 3-28 4.69-42.65 4.69v-27.38c1.69-12.62-7.64-36.26-22.63-51.25-6-6-9.37-14.14-9.37-22.63v-32.01c0-11.64-6.27-22.34-16.46-27.97-14.37-7.95-34.81-19.06-48.81-26.11-11.48-5.78-22.1-13.14-31.65-21.75l-.8-.72a114.792 114.792 0 0 1-18.06-20.74c-9.38-13.77-24.66-36.42-34.59-51.14 20.47-45.5 57.36-82.04 103.2-101.89l24.01 12.01C203.48 89.74 216 82.01 216 70.11v-11.3c7.99-1.29 16.12-2.11 24.39-2.42l28.3 28.3c6.25 6.25 6.25 16.38 0 22.63L264 112l-10.34 10.34c-3.12 3.12-3.12 8.19 0 11.31l4.69 4.69c3.12 3.12 3.12 8.19 0 11.31l-8 8a8.008 8.008 0 0 1-5.66 2.34h-8.99c-2.08 0-4.08.81-5.58 2.27l-9.92 9.65a8.008 8.008 0 0 0-1.58 9.31l15.59 31.19c2.66 5.32-1.21 11.58-7.15 11.58h-5.64c-1.93 0-3.79-.7-5.24-1.96l-9.28-8.06a16.017 16.017 0 0 0-15.55-3.1l-31.17 10.39a11.95 11.95 0 0 0-8.17 11.34c0 4.53 2.56 8.66 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 ausl\u00e4ndische Hersteller<\/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 helfen Unternehmen, die Erwartungen der FDA beim Eintritt in den US-Markt zu verstehen.<\/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\">Erfahrung mit 510(k), Dokumentation und Compliance<\/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 Unterst\u00fctzung verbindet die regulatorische Strategie mit der technischen Dokumentation und dem Marktzugang.<\/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 n\u00e4chste Schritte f\u00fcr Ihr Team<\/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\">Sie erhalten praktische Hinweise, was Sie korrigieren, vervollst\u00e4ndigen oder \u00fcberpr\u00fcfen m\u00fcssen, 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>\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<\/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\">Informieren Sie uns \u00fcber 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\">Teilen Sie uns mit, wo Sie sich in diesem Prozess befinden, und wir werden herausfinden, wie Sobel Sie bei Ihrem n\u00e4chsten regulatorischen Schritt unterst\u00fctzen kann.\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 - eu-cpsr-eng\" aria-label=\"Kontakt-Formular - eu-cpsr-eng\">\n\t\t\t<input type=\"hidden\" name=\"post_id\" value=\"37346\"\/>\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)-Reife pr\u00fcfen<\/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\">Was, wenn wir nicht sicher sind, welches Pr\u00e4dikat wir verwenden sollen?<\/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 data-start=\"6465\" data-end=\"6543\">Sobel kann Sie bei der \u00dcberpr\u00fcfung Ihrer Ger\u00e4teinformationen, des Verwendungszwecks, der Anspr\u00fcche und der verf\u00fcgbaren Beweise unterst\u00fctzen, um zu beurteilen, ob Ihre Pr\u00e4dikatslogik stark genug ist oder vor der Einreichung noch weiter gekl\u00e4rt werden muss.<\/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\">Woher wissen wir, ob unser 510(k)-Weg angemessen ist?<\/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>Wir pr\u00fcfen die Positionierung Ihres Produkts, den Verwendungszweck, die Technologie, das Risikoprofil und den regulatorischen Kontext, um zu kl\u00e4ren, ob Ihr aktueller 510(k)-Pfad mit den Erwartungen der FDA \u00fcbereinstimmt.<\/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 unser Team die 510(k) bereits eingeleitet hat?<\/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>Ja. Wenn Ihr Team bereits mit der Vorbereitung der Dokumentation begonnen hat, kann Sobel die aktuellen Materialien \u00fcberpr\u00fcfen, L\u00fccken aufdecken und dabei helfen zu kl\u00e4ren, was m\u00f6glicherweise korrigiert, erg\u00e4nzt oder verst\u00e4rkt werden muss, bevor Sie fortfahren. <\/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\">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-2344\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-2344\"><p>Im Idealfall hat Ihr Unternehmen ein definiertes Medizinprodukt, einen Verwendungszweck, einen Zielmarkt und zumindest einige technische, beschreibende, pr\u00fcfende oder beh\u00f6rdliche Unterlagen zur \u00dcberpr\u00fcfung zur Verf\u00fcgung.<\/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\":\"Was, wenn wir nicht sicher sind, welches Pr\\u00e4dikat wir verwenden sollen?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p data-start=\\\"6465\\\" data-end=\\\"6543\\\">Sobel kann Sie bei der \\u00dcberpr\\u00fcfung Ihrer Ger\\u00e4teinformationen, des Verwendungszwecks, der Anspr\\u00fcche und der verf\\u00fcgbaren Beweise unterst\\u00fctzen, um zu beurteilen, ob Ihre Pr\\u00e4dikatslogik stark genug ist oder vor der Einreichung noch weiter gekl\\u00e4rt werden muss.<\\\/p>\\n\"}},{\"@type\":\"Question\",\"name\":\"Woher wissen wir, ob unser 510(k)-Weg angemessen ist?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>Wir pr\\u00fcfen die Positionierung Ihres Produkts, den Verwendungszweck, die Technologie, das Risikoprofil und den regulatorischen Kontext, um zu kl\\u00e4ren, ob Ihr aktueller 510(k)-Pfad mit den Erwartungen der FDA \\u00fcbereinstimmt.<\\\/p>\\n\"}},{\"@type\":\"Question\",\"name\":\"Kann Sobel helfen, wenn unser Team die 510(k) bereits eingeleitet hat?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>Ja. 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