{"id":4831,"date":"2025-06-01T10:00:00","date_gmt":"2025-06-01T13:00:00","guid":{"rendered":"https:\/\/sobelconsult.com\/unterstuetzung-im-qualitaetsmanagement-usa\/"},"modified":"2026-02-02T15:11:59","modified_gmt":"2026-02-02T18:11:59","slug":"medical-device-quality-consulting","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/de\/our-solutions-usa\/medical-device-quality-consulting\/","title":{"rendered":"Unterst\u00fctzung im Qualit\u00e4tsmanagement - USA"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"4831\" class=\"elementor elementor-4831 elementor-1764\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-72b434b e-flex e-con-boxed e-con e-parent\" data-id=\"72b434b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-01c0a58 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"01c0a58\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Qualit\u00e4tsberatung f\u00fcr Medizinprodukte f\u00fcr die FDA<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f9b9811 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"f9b9811\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"A strong Quality Management System is essential for any medical device manufacturer aiming for regulatory success. Whether you're building your QMS from scratch or refining an existing one, Sobel\u2019s medical device quality consulting services provide the structure, clarity, and expert guidance your company needs.\"}]\" data-inline-monday=\"true\">Ein starkes Qualit\u00e4tsmanagementsystem ist f\u00fcr jeden Hersteller von Medizinprodukten, der erfolgreich sein will, unerl\u00e4sslich. Ganz gleich, ob Sie Ihr QMS von Grund auf neu aufbauen oder ein bestehendes System verfeinern wollen, Sobels Beratungsdienste f\u00fcr die Qualit\u00e4t von Medizinprodukten bieten die Struktur, die Klarheit und die fachkundige Anleitung, die Ihr Unternehmen ben\u00f6tigt. <\/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-d2e27c5 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"d2e27c5\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6NzM0MywidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Holen Sie sich Expertenunterst\u00fctzung<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e01a0a4 e-flex e-con-boxed e-con e-parent\" data-id=\"e01a0a4\" 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-d39b344 e-con-full e-flex e-con e-child\" data-id=\"d39b344\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-f26bed8 e-con-full e-transform e-flex e-con e-child\" data-id=\"f26bed8\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation_mobile&quot;:&quot;fadeIn&quot;,&quot;_transform_translateX_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:96,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:-109,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-66e1e48 elementor-widget elementor-widget-heading\" data-id=\"66e1e48\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\">F\u00fcr wen?<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a3994c6 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"a3994c6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f6b45c6 elementor-align-end elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"f6b45c6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Unternehmen, die Produkte f\u00fcr den US-Markt vorbereiten oder sich FDA-Inspektionen unterziehen.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Hersteller, die ihre QMS-Dokumentation mit 21 CFR 820, ISO 13485 oder MDSAP abgleichen.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Startups, die ihr erstes QMS aufbauen und eine strukturierte Anleitung ben\u00f6tigen.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Teams, die sich um unabh\u00e4ngige Bewertungen, interne Audits oder L\u00fcckenanalysen bem\u00fchen.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Unternehmen, die eine kontinuierliche Unterst\u00fctzung bei der Anwendung von Qualit\u00e4tsmanagementverfahren suchen.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-05d680a e-con-full e-flex e-con e-child\" data-id=\"05d680a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation_mobile&quot;:&quot;fadeIn&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-834204e elementor-widget elementor-widget-image\" data-id=\"834204e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"755\" height=\"1024\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-755x1024.png\" class=\"attachment-large size-large wp-image-18565\" alt=\"A portable vital signs monitor sits on a table. Office supplies are also on the table. It looks like a doctor&#039;s office.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-755x1024.png 755w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-221x300.png 221w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services-768x1041.png 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/image-medcialdevices-services.png 1011w\" sizes=\"(max-width: 755px) 100vw, 755px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2d5f9cb e-flex e-con-boxed e-con e-parent\" data-id=\"2d5f9cb\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4fa02d2 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"4fa02d2\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Let Sobel check whether your processes are compliant, efficient, and ready for regulatory scrutiny.\"}]\" data-inline-monday=\"true\">Lassen Sie Sobel pr\u00fcfen, ob Ihre Prozesse konform und effizient sind und ob sie f\u00fcr eine beh\u00f6rdliche \u00dcberpr\u00fcfung bereit sind.<\/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-0ecec6d elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"0ecec6d\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6NzM0MywidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Holen Sie sich Unterst\u00fctzung!<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6c52ce7 e-flex e-con-boxed e-con e-parent\" data-id=\"6c52ce7\" 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-efc4cfb elementor-widget-mobile__width-inherit elementor-widget elementor-widget-image\" data-id=\"efc4cfb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1259\" height=\"275\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue.png\" class=\"attachment-full size-full wp-image-18571\" alt=\"Vector rectangle blue\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue.png 1259w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue-300x66.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue-1024x224.png 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/rectangle-md-blue-768x168.png 768w\" sizes=\"(max-width: 1259px) 100vw, 1259px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-28c1ad5 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"28c1ad5\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Warum brauchen Sie diesen Service?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d3fe162 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"d3fe162\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-6eb90b2 e-con-full e-flex e-con e-child\" data-id=\"6eb90b2\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d40196d elementor-widget elementor-widget-text-editor\" data-id=\"d40196d\" 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\":\"Regulatory expectations require strong procedures, clear documentation, and objective proof of implementation.\"}]\" data-inline-monday=\"true\">Die Erwartungen der Regulierungsbeh\u00f6rden erfordern strenge Verfahren, eine klare Dokumentation und einen objektiven Nachweis der Umsetzung.<\/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-c87b0ee e-con-full e-flex e-con e-child\" data-id=\"c87b0ee\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6b7f22e elementor-widget elementor-widget-text-editor\" data-id=\"6b7f22e\" 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 structured, compliant QMS prevents nonconformities, reduces inspection risks, and strengthens product quality and safety.\"}]\" data-inline-monday=\"true\">Ein strukturiertes, konformes QMS verhindert Nichtkonformit\u00e4ten, reduziert Inspektionsrisiken und st\u00e4rkt die Produktqualit\u00e4t und -sicherheit.<\/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-787507b e-con-full e-flex e-con e-child\" data-id=\"787507b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0c2f323 elementor-widget elementor-widget-text-editor\" data-id=\"0c2f323\" 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\":\"Expert guidance accelerates alignment with FDA and ISO requirements, turning complex rules into clear, actionable processes.\"}]\" data-inline-monday=\"true\">Fachkundige Anleitung beschleunigt die Anpassung an FDA- und ISO-Anforderungen und verwandelt komplexe Regeln in klare, umsetzbare Prozesse.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-57ab26c e-flex e-con-boxed e-con e-parent\" data-id=\"57ab26c\" 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-caaefb4 e-con-full e-flex e-con e-child\" data-id=\"caaefb4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4996e7a elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"4996e7a\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Fachkundige Qualit\u00e4tsberatung f\u00fcr Medizinprodukte, die Ihr QMS st\u00e4rkt<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c316a08 e-con-full e-flex e-con e-child\" data-id=\"c316a08\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2173495 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"2173495\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"With increasing expectations from FDA 21 CFR 820, ISO 13485, and MDSAP, your QMS must go beyond documentation\u2014it must work in practice. \"}]\" data-inline-monday=\"true\">Angesichts der steigenden Erwartungen von FDA 21 CFR 820, ISO 13485 und MDSAP muss Ihr QMS \u00fcber die Dokumentation hinausgehen - es muss in der Praxis funktionieren.  <\/p><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"attributes\":{\"sanitizedSize\":\"16px\"},\"insert\":\"Our medical device quality consulting services follow a clear, collaborative method that adapts to your company\u2019s scope, maturity, and regulatory objectives. \"},{\"insert\":\"\\n\"}]\" data-inline-monday=\"true\"><strong>Unsere Beratungsdienste f\u00fcr die Qualit\u00e4t von Medizinprodukten folgen einer klaren, kooperativen Methode, die sich an den Umfang, den Reifegrad und die regulatorischen Ziele Ihres Unternehmens anpasst.  <\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-cee19e7 e-flex e-con-boxed e-con e-parent\" data-id=\"cee19e7\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d9795b8 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"d9795b8\" 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\">Holen Sie sich Qualit\u00e4tsberatung f\u00fcr Medizinprodukte, die die Einhaltung von Vorschriften f\u00f6rdert.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-65f202e elementor-widget elementor-widget-ucaddon_horizontal_timeline\" data-id=\"65f202e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"ucaddon_horizontal_timeline.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\n<!-- start Horizontal Timeline -->\n\t\t<link id='font-awesome-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/font-awesome6\/fontawesome-all.min.css' type='text\/css' rel='stylesheet' >\n\t\t<link id='font-awesome-4-shim-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/font-awesome6\/fontawesome-v4-shims.min.css' type='text\/css' rel='stylesheet' >\n\t\t<link id='owl-carousel-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/owl-carousel-new\/assets\/owl.carousel.css' type='text\/css' rel='stylesheet' >\n\n<style>\/* widget: Horizontal Timeline *\/\n\n#uc_horizontal_timeline_elementor_65f202e *{\n  box-sizing:border-box;\n}\n\n#uc_horizontal_timeline_elementor_65f202e{\n  position:relative;\n  min-height:1px;\n}\n\n#uc_horizontal_timeline_elementor_65f202e .ue-carousel-content{\n    display: flex;\n    flex-flow: column nowrap;\n    flex:1;\n}\n\n#uc_horizontal_timeline_elementor_65f202e .ue-carousel-item{\n  overflow:hidden;\n  position:relative;\n  display:flex;\n}\n\n#uc_horizontal_timeline_elementor_65f202e .ue-btn-holder{\n  margin-top:auto;\n}\n\n#uc_horizontal_timeline_elementor_65f202e .ue-btn{\n  text-align:center;\n  text-decoration:none;\n  transition:0.3s;\n} \n\n#uc_horizontal_timeline_elementor_65f202e .item-horizontal-timeline .ue-item-title{\n  font-size:21px;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_65f202e .carousel-nav{\n  position:relative;\n  z-index:10;\n}\n\n#uc_horizontal_timeline_elementor_65f202e .carousel-nav .carousel-prev{\n    position:absolute;\n      display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_65f202e .carousel-nav .carousel-next{\n  position:absolute;\n  display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_65f202e  .carousel-nav button svg, \n#uc_horizontal_timeline_elementor_65f202e  .carousel-nav button i{\n  position: absolute;\n     top: 50%;\n  left: 50%;\n  transform: translate(-50%, -50%);\n}\n\n#uc_horizontal_timeline_elementor_65f202e .owl-dots {\n  overflow:hidden;\n  display:true !important;  \n}\n\n#uc_horizontal_timeline_elementor_65f202e .owl-dot {\n  border-radius:50%;\n  display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_65f202e .ue-item-bullet-holder{\n  display:flex;\n  align-items:center;\n}\n\n#uc_horizontal_timeline_elementor_65f202e .ue-item-bullet-line{\n  flex-grow:1;\n}\n\n#uc_horizontal_timeline_elementor_65f202e .ue-item-bullet-line-spacing{\n  flex-grow:0;\n  flex-shrink:0;\n}\n\n#uc_horizontal_timeline_elementor_65f202e .ue-item-bullet{\n  position:relative;\n  transition: all .3s ease;\n}\n\n#uc_horizontal_timeline_elementor_65f202e .ue-item-bullet i, #uc_horizontal_timeline_elementor_65f202e .ue-item-bullet svg{\n  position: absolute;\n  top: 50%;\n  left: 50%;\n  transform: translate(-50%, -50%); \n}\n\n#uc_horizontal_timeline_elementor_65f202e .ue-item-label a{\n  font-size:12px;\n  line-height:1.5em;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_65f202e .ue-item-image{\n  overflow:hidden;\n}\n\n#uc_horizontal_timeline_elementor_65f202e .ue-item-image a{\n  display:block;\n}\n\n#uc_horizontal_timeline_elementor_65f202e .ue-item-image img{\n  object-fit: cover;\n  width:100%;\n  transition:0.3s;\n}\n\n#uc_horizontal_timeline_elementor_65f202e .ue-item-vertical-line-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_65f202e .ue-item-pointer-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_65f202e .ue-carousel-item:hover .ue-item-image img{\n  transform:scale(1.1,1.1);\n}\n\n#uc_horizontal_timeline_elementor_65f202e .ue-item-label{\n display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_65f202e .ue-carousel-item-holder{\n  display: flex;\n  flex-direction: column;\n  align-items: stretch;\n  height:100%;\n}\n\n<\/style>\n\n<div class=\"ue-horizontal-timeline\" id=\"uc_horizontal_timeline_elementor_65f202e\">\n     <div class=\"carousel-nav\">\n            <button class=\"carousel-prev\" aria-label=\"Previous\">\n                <i class=' ti-arrow-circle-left'><\/i>\n            <\/button>\n            <button class=\"carousel-next\" aria-label=\"Next\">\n                <i class=' ti-arrow-circle-right'><\/i>\n            <\/button>\n        <\/div>\n    <div class=\"owl-carousel owl-theme uc-items-wrapper item-horizontal-timeline  \" id=\"uc_horizontal_timeline_elementor_65f202e\" data-custom-sethtml=\"true\"  >\n     \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-58fbbfd\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >W\u00e4hlen Sie Ihren Service<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">W\u00e4hlen Sie die Art der Qualit\u00e4tsunterst\u00fctzung, die Ihr Unternehmen ben\u00f6tigt - von internen Audits \u00fcber L\u00fcckenbewertungen bis hin zur vollst\u00e4ndigen QMS-Implementierung.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-5ca2a2a\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Definition des Umfangs<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Wir ermitteln die anwendbaren Standards, die regulatorischen Erwartungen und den aktuellen Reifegrad Ihres Unternehmens, um die Arbeit zu strukturieren.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-9cdd855\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Gemeinsame Ausf\u00fchrung<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Unsere Experten f\u00fchren Bewertungen, \u00dcberpr\u00fcfungen oder Audits durch und leiten Ihr Team durch die Ergebnisse und Verbesserungsstrategien.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-e43fc00\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Erzielte Ergebnisse<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Sie erhalten strukturierte Berichte, klare Empfehlungen und dokumentierte Ergebnisse, die den Erwartungen der Beh\u00f6rden entsprechen.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-26467d6\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Optionale weitere Unterst\u00fctzung<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Wenn Ihr Team weitere Unterst\u00fctzung ben\u00f6tigt, k\u00f6nnen wir je nach Komplexit\u00e4t Ihrer Anforderungen zus\u00e4tzliche Beratung einplanen.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n\n  <\/div>\n<\/div>\n<!-- end Horizontal Timeline -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f682b09 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"f682b09\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6NzM0MywidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Beginnen Sie jetzt!<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4b9ad34 animated-slow e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"4b9ad34\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a45ae6c elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"a45ae6c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Welcher Service unterst\u00fctzt Ihr Qualit\u00e4tsmanagementsystem am besten?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fa4a562 elementor-widget elementor-widget-text-editor\" data-id=\"fa4a562\" 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\":\"Depending on your company\u2019s stage and regulatory goals, you can request an internal audit, a gap analysis, targeted consulting support, or complete QMS implementation guidance. \"}]\" data-inline-monday=\"true\">Je nach Stadium und Zielsetzung Ihres Unternehmens k\u00f6nnen Sie ein internes Audit, eine L\u00fcckenanalyse, gezielte Beratungsunterst\u00fctzung oder eine vollst\u00e4ndige Anleitung zur Implementierung des QMS anfordern.<\/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-98e5ab8 e-flex e-con-boxed e-con e-child\" data-id=\"98e5ab8\" 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-48ceac5 e-con-full e-flex e-con e-child\" data-id=\"48ceac5\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4202992 elementor-widget elementor-widget-heading\" data-id=\"4202992\" 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\">Interne Revision<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6632b4d elementor-widget elementor-widget-text-editor\" data-id=\"6632b4d\" 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\":\"Best for companies needing an independent, structured evaluation of their Quality Management System. This remote audit verifies procedure completeness, conformity with the applicable standard, and real-world implementation. \"}]\" data-inline-monday=\"true\">Ideal f\u00fcr Unternehmen, die eine unabh\u00e4ngige, strukturierte Bewertung ihres Qualit\u00e4tsmanagementsystems ben\u00f6tigen. Dieses Fernaudit \u00fcberpr\u00fcft die Vollst\u00e4ndigkeit der Verfahren, die Konformit\u00e4t mit dem geltenden Standard und die praktische Umsetzung. <\/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-f8faece e-con-full e-flex e-con e-child\" data-id=\"f8faece\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b788e31 elementor-widget elementor-widget-heading\" data-id=\"b788e31\" 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\">Risikomanagement - Kritische Analyse<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a50d41d elementor-widget elementor-widget-text-editor\" data-id=\"a50d41d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Ideal when you need a technical assessment of your Risk Management Plan and Report. We analyze gaps, evaluate alignment with ISO 14971, and provide clear improvement recommendations. The service focuses on analysis.\"}]\" data-inline-monday=\"true\">Ideal, wenn Sie eine technische Bewertung Ihres Risikomanagementplans und -berichts ben\u00f6tigen. Wir analysieren L\u00fccken, bewerten die \u00dcbereinstimmung mit ISO 14971 und geben klare Verbesserungsempfehlungen. Dieser Service konzentriert sich auf die Analyse.  <\/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-0282244 e-con-full e-flex e-con e-child\" data-id=\"0282244\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7c1e0a3 elementor-widget elementor-widget-heading\" data-id=\"7c1e0a3\" 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\">QMS-Anpassung an 21 CFR 820 (ISO 13485 implementiert)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4beaa86 elementor-widget elementor-widget-text-editor\" data-id=\"4beaa86\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Designed for companies with an ISO 13485-based QMS needing alignment with U.S. FDA requirements. We review your Quality Manual and procedures, perform a gap assessment, and provide guidance for one revision. \"}]\" data-inline-monday=\"true\">Konzipiert f\u00fcr Unternehmen mit einem auf ISO 13485 basierenden QMS, das an die Anforderungen der US-FDA angepasst werden muss. Wir \u00fcberpr\u00fcfen Ihr Qualit\u00e4tshandbuch und Ihre Verfahren, f\u00fchren eine L\u00fcckenbewertung durch und geben Ihnen eine Anleitung f\u00fcr eine \u00dcberarbeitung. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-0017962 e-flex e-con-boxed e-con e-child\" data-id=\"0017962\" 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-73b2078 e-con-full e-flex e-con e-child\" data-id=\"73b2078\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2e7764b elementor-widget elementor-widget-heading\" data-id=\"2e7764b\" 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\">QMS-Anpassung an 21 CFR 820 (keine ISO 13485 implementiert)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5b88700 elementor-widget elementor-widget-text-editor\" data-id=\"5b88700\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"For companies without ISO 13485 implementation. We review your QMS documents and assess gaps against 21 CFR 820 and ISO 13485:2016, providing guidance for one revision. \"}]\" data-inline-monday=\"true\">F\u00fcr Unternehmen ohne ISO 13485-Implementierung. Wir \u00fcberpr\u00fcfen Ihre QMS-Dokumente und bewerten L\u00fccken in Bezug auf 21 CFR 820 und ISO 13485:2016 und geben Ihnen eine Anleitung f\u00fcr eine \u00dcberarbeitung. <\/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-1630c6c e-con-full e-flex e-con e-child\" data-id=\"1630c6c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d571d93 elementor-widget elementor-widget-heading\" data-id=\"d571d93\" 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\">QMS von Grund auf neu einrichten<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c12cfc0 elementor-widget elementor-widget-text-editor\" data-id=\"c12cfc0\" 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\":\"The most comprehensive option\u2014ideal for startups or manufacturers building their first quality system. Includes assessment of applicable requirements, guidance for drafting procedures and the Quality Manual, review and gap assessment of drafted documents, internal audit execution, and support in preparing for certification audits. \"}]\" data-inline-monday=\"true\">Die umfassendste Option - ideal f\u00fcr Start-ups oder Hersteller, die ihr erstes Qualit\u00e4tssystem aufbauen. Beinhaltet die Bewertung der anwendbaren Anforderungen, Anleitungen f\u00fcr die Erstellung von Verfahren und des Qualit\u00e4tshandbuchs, die \u00dcberpr\u00fcfung und L\u00fcckenbewertung der erstellten Dokumente, die Durchf\u00fchrung interner Audits und die Unterst\u00fctzung bei der Vorbereitung auf Zertifizierungsaudits. <\/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-914eb10 e-con-full e-flex e-con e-child\" data-id=\"914eb10\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9dee299 elementor-widget elementor-widget-heading\" data-id=\"9dee299\" 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\">Monatliche Beratung - Unterst\u00fctzung bei QMS-Fragen<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-77e4f0f elementor-widget elementor-widget-text-editor\" data-id=\"77e4f0f\" 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\":\"Perfect for teams needing continuous guidance on quality-related questions. Your inquiries are submitted through our project management platform, and experts provide written answers. \"}]\" data-inline-monday=\"true\">Perfekt f\u00fcr Teams, die kontinuierliche Beratung zu qualit\u00e4tsbezogenen Fragen ben\u00f6tigen. Ihre Anfragen werden \u00fcber unsere Projektmanagement-Plattform eingereicht, und Experten geben schriftliche Antworten. <\/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 class=\"elementor-element elementor-element-8d5e2a2 elementor-widget elementor-widget-text-editor\" data-id=\"8d5e2a2\" 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\":\"Whether remotely or on-site, we guide your team through assessments, documentation reviews, internal audits, and improvement strategies, ensuring practical, inspection-ready outcomes.\"}]\" data-inline-monday=\"true\">Ob aus der Ferne oder vor Ort, wir leiten Ihr Team durch Bewertungen, Dokumentationspr\u00fcfungen, interne Audits und Verbesserungsstrategien und sorgen so f\u00fcr praktische, pr\u00fcfungsreife Ergebnisse.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e2d62b9 e-flex e-con-boxed e-con e-parent\" data-id=\"e2d62b9\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-827e4b8 e-con-full e-flex e-con e-child\" data-id=\"827e4b8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8fe9d5d elementor-widget__width-inherit elementor-widget-divider--view-line elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"8fe9d5d\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-860dc91 elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"860dc91\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Verwandte Dienstleistungen <br><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-df5333a elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"df5333a\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"From focused assessments to full QMS construction, Sobel delivers the structure and expertise needed to create a compliant, functional, and inspection-ready Quality Management System. You can also receive support with:\"}]\" data-inline-monday=\"true\">Von gezielten Bewertungen bis hin zum Aufbau eines vollst\u00e4ndigen QMS bietet Sobel die Struktur und das Fachwissen, das f\u00fcr die Schaffung eines konformen, funktionalen und pr\u00fcfungsreifen Qualit\u00e4tsmanagementsystems erforderlich ist. Sie k\u00f6nnen auch Unterst\u00fctzung erhalten bei: <\/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-220c02f e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"220c02f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-00298ff e-con-full e-flex e-con e-child\" data-id=\"00298ff\" 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-6a64fe9 elementor-widget elementor-widget-heading\" data-id=\"6a64fe9\" 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\">Audit und Qualifizierung von Lieferanten<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-26e36c9 elementor-widget elementor-widget-text-editor\" data-id=\"26e36c9\" 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\":\"Strengthen your supply chain with supplier audit and qualification services. \"}]\" data-inline-monday=\"true\">St\u00e4rken Sie Ihre Lieferkette mit Lieferantenaudits und Qualifizierungsdienstleistungen.<\/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-f3c2c37 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"f3c2c37\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/sobelconsult.com\/de\/our-solutions-usa\/medical-device-supplier-audit-qualification\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Mehr sehen<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c6a1102 e-con-full e-flex e-con e-child\" data-id=\"c6a1102\" 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-cbf47ff elementor-widget elementor-widget-heading\" data-id=\"cbf47ff\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Biologische Bewertung (BEP, BER)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bb4dd56 elementor-widget elementor-widget-text-editor\" data-id=\"bb4dd56\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7d42130 elementor-widget elementor-widget-text-editor\" data-id=\"7d42130\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><div class=\"elementor-element elementor-element-7d42130 elementor-widget elementor-widget-text-editor\" data-id=\"7d42130\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"attributes\":{\"background\":\"var(--color-egg_yolk-selected)\"},\"insert\":\"BEP, BER, and toxicological support. Clear, defensible biological evaluation documentation.\"}]\" data-inline-monday=\"true\">BEP, BER, und toxikologische Unterst\u00fctzung. Klare, vertretbare Dokumentation der biologischen Bewertung. <\/p><\/div><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3225da8 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"3225da8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/sobelconsult.com\/de\/our-solutions-usa\/biological-evaluation-medical-device\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Mehr sehen<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-997ad02 e-con-full e-flex e-con e-child\" data-id=\"997ad02\" 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-29659d0 elementor-widget elementor-widget-heading\" data-id=\"29659d0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">US-Agentendienst<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6c7df7b elementor-widget elementor-widget-text-editor\" data-id=\"6c7df7b\" 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\":\"Navigate market access in the U.S.A. with Sobel as your device US Agent.\"}]\" data-inline-monday=\"true\">Navigieren Sie durch den Marktzugang in den USA mit Sobel als Ihrem US-Agent.<\/p>\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-02db5c8 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"02db5c8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/sobelconsult.com\/de\/our-solutions-usa\/fda-us-agent\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Mehr sehen<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\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-cee9bf0 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"cee9bf0\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-e28418a e-con-full e-flex e-con e-child\" data-id=\"e28418a\" 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-b148a13 e-con-full e-flex e-con e-child\" data-id=\"b148a13\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-76adba4 elementor-widget-laptop__width-initial elementor-widget elementor-widget-heading\" data-id=\"76adba4\" 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\">St\u00e4rken Sie Ihr Qualit\u00e4tsmanagementsystem mit fachkundiger Unterst\u00fctzung<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9da792b elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"9da792b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Ein konformes, gut strukturiertes QMS ist f\u00fcr den regulatorischen Erfolg und den langfristigen Marktzugang unerl\u00e4sslich. Durch die Qualit\u00e4tsberatung von Sobel f\u00fcr Medizinprodukte erh\u00e4lt Ihr Team die Klarheit, Effizienz und praktische Anleitung, die es braucht, um die Anforderungen von FDA, ISO und MDSAP zu erf\u00fcllen - ohne unn\u00f6tige Komplexit\u00e4t hinzuzuf\u00fcgen. <\/p><p><strong>Beginnen Sie noch heute mit dem Aufbau eines st\u00e4rkeren, regelkonformen QMS.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f3a2383 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"f3a2383\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6NzM0MywidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Beginnen Sie jetzt!<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6c06de2 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"6c06de2\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a7a352b elementor-widget__width-inherit elementor-widget elementor-widget-toggle\" data-id=\"a7a352b\" 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-1751\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-1751\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Haben Sie noch Fragen? Schauen Sie in unsere FAQ <\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1751\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-1751\"><p><b>1. Was ist der Unterschied zwischen FDA 21 CFR 820 und ISO 13485?<\/b><\/p>\n<p>FDA 21 CFR 820 ist die U.S. Quality System Regulation (QSR), die f\u00fcr in den Vereinigten Staaten vertriebene Medizinprodukte gesetzlich vorgeschrieben ist. ISO 13485 ist ein international anerkannter QMS-Standard. Die beiden Normen sind \u00e4hnlich, aber nicht identisch - die FDA verlangt zus\u00e4tzliche Kontrollen, Dokumentation und Inspektionsbereitschaft, die \u00fcber ISO 13485 hinausgehen.  <\/p>\n<p><b>2. Garantiert die ISO 13485-Zertifizierung die Einhaltung von FDA 21 CFR 820?<\/b><\/p>\n<p>Nein. ISO 13485 bietet zwar eine solide Grundlage, ersetzt aber nicht die Einhaltung von 21 CFR 820. Die Hersteller m\u00fcssen weiterhin die Dokumentation, die Prozesse und die Umsetzung mit den Erwartungen der FDA in Einklang bringen.  <\/p>\n<p><b>3. Brauche ich ein QMS, wenn mein Produkt noch nicht auf dem Markt ist?<\/b><\/p>\n<p>Ja. Die FDA erwartet, dass die Hersteller \u00fcber ein funktionierendes, dokumentiertes und implementiertes QMS verf\u00fcgen, bevor sie die meisten Antr\u00e4ge einreichen oder Produkte f\u00fcr den Vertrieb produzieren. <\/p>\n<p><b>5. Ist ein internes Fernaudit f\u00fcr die Einhaltung der FDA-Vorschriften akzeptabel?<\/b><\/p>\n<p>Ja. Die FDA verlangt nicht, dass interne Audits vor Ort durchgef\u00fchrt werden. Audits aus der Ferne sind akzeptabel, solange die \u00dcberpr\u00fcfung gr\u00fcndlich und dokumentiert ist und sowohl die Verfahren als auch die Umsetzung bewertet.  <\/p>\n<p><b>6. Wie oft sollte ein Medizinprodukteunternehmen interne Audits durchf\u00fchren?<\/b><\/p>\n<p>Mindestens einmal pro Jahr oder h\u00e4ufiger, je nach Produktrisiko, j\u00fcngsten \u00c4nderungen oder Vorbereitung auf eine bevorstehende FDA-Inspektion oder ein Zertifizierungsaudit.<\/p>\n<p><b>7. Ben\u00f6tige ich separate Verfahren f\u00fcr FDA, ISO 13485 und MDSAP?<\/b><\/p>\n<p>Nicht unbedingt. Ein einziges, gut strukturiertes QMS kann alle drei Rahmenwerke erf\u00fcllen, wenn es richtig konzipiert ist. Der Schl\u00fcssel liegt darin, sicherzustellen, dass Ihre Dokumentation alle geltenden gesetzlichen Anforderungen widerspiegelt.  <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Fachkundige Qualit\u00e4tsberatung f\u00fcr Medizinprodukte zur Anpassung Ihres QMS an FDA 21 CFR 820, ISO 13485 und MDSAP in den USA.<\/p>\n","protected":false},"author":11,"featured_media":7200,"parent":7783,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-4831","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.3 (Yoast SEO v26.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Qualit\u00e4tsberatung f\u00fcr medizinische Ger\u00e4te | QMS-Unterst\u00fctzung<\/title>\n<meta name=\"description\" content=\"Fachkundige Qualit\u00e4tsberatung f\u00fcr Medizinprodukte zur Anpassung Ihres QMS an FDA 21 CFR 820, ISO 13485 und MDSAP in den USA.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/sobelconsult.com\/de\/our-solutions-usa\/medical-device-quality-consulting\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Unterst\u00fctzung im Qualit\u00e4tsmanagement - USA\" \/>\n<meta property=\"og:description\" content=\"Fachkundige Qualit\u00e4tsberatung f\u00fcr Medizinprodukte zur Anpassung Ihres QMS an FDA 21 CFR 820, ISO 13485 und MDSAP in den USA.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sobelconsult.com\/de\/our-solutions-usa\/medical-device-quality-consulting\/\" \/>\n<meta property=\"og:site_name\" content=\"Sobel\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-02T18:11:59+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Quality-Management.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1000\" \/>\n\t<meta property=\"og:image:height\" content=\"657\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/sobelconsult.com\/de\/our-solutions-usa\/medical-device-quality-consulting\/\",\"url\":\"https:\/\/sobelconsult.com\/de\/our-solutions-usa\/medical-device-quality-consulting\/\",\"name\":\"Qualit\u00e4tsberatung f\u00fcr medizinische Ger\u00e4te | QMS-Unterst\u00fctzung\",\"isPartOf\":{\"@id\":\"https:\/\/sobelconsult.com\/de\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/sobelconsult.com\/de\/our-solutions-usa\/medical-device-quality-consulting\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/sobelconsult.com\/de\/our-solutions-usa\/medical-device-quality-consulting\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Quality-Management.webp\",\"datePublished\":\"2025-06-01T13:00:00+00:00\",\"dateModified\":\"2026-02-02T18:11:59+00:00\",\"description\":\"Fachkundige Qualit\u00e4tsberatung f\u00fcr Medizinprodukte zur Anpassung Ihres QMS an FDA 21 CFR 820, ISO 13485 und MDSAP in den USA.\",\"breadcrumb\":{\"@id\":\"https:\/\/sobelconsult.com\/de\/our-solutions-usa\/medical-device-quality-consulting\/#breadcrumb\"},\"inLanguage\":\"de\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/sobelconsult.com\/de\/our-solutions-usa\/medical-device-quality-consulting\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"de\",\"@id\":\"https:\/\/sobelconsult.com\/de\/our-solutions-usa\/medical-device-quality-consulting\/#primaryimage\",\"url\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Quality-Management.webp\",\"contentUrl\":\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/04\/Quality-Management.webp\",\"width\":1000,\"height\":657,\"caption\":\"Standard quality control collage concept\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/sobelconsult.com\/de\/our-solutions-usa\/medical-device-quality-consulting\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\/\/sobelconsult.com\/de\/home\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Unsere L\u00f6sungen USA\",\"item\":\"https:\/\/sobelconsult.com\/de\/our-solutions-usa\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Unterst\u00fctzung im Qualit\u00e4tsmanagement &#8211; 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