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i{width:38px;height:38px;font-size:16px}.ss-tb{margin-bottom:16px}.ss-tb-p{padding:20px 24px}.ss-tb-img{height:200px}.ss-tb-lead{font-size:20px}#ss-route .ss-after2{margin-top:16px}}\n@media (max-width:1024px){.ss-tb{grid-template-columns:repeat(3,1fr);gap:12px}.ss-tb-cols{grid-template-columns:1fr 1fr}.ss-tb-img{grid-column:1\/-1;height:220px}}\n@media (max-width:767px){.ss-tb{grid-template-columns:1fr 1fr;gap:10px}.ss .ss-tb-t{padding:14px 12px;gap:10px}.ss .ss-tb-t i{width:34px;height:34px;font-size:15px}.ss .ss-tb-t b{font-size:14px}.ss .ss-tb-t small{font-size:12px}.ss-tb-p{padding:18px;border-left-width:4px}.ss-tb-cols{grid-template-columns:1fr;gap:16px}.ss-tb-img{display:none}.ss-tb-lead{font-size:19px}}\n\n\/* steps tabs: exact behaviour of the Clinical Evidence pillar, no motion (07\/11\/2026) *\/\n.ss button.ss-tb-t,.ss button.ss-tb-t:hover,.ss button.ss-tb-t:focus{display:flex!important;flex-direction:row!important;align-items:center!important;gap:12px!important;text-align:left!important;border:0!important;border-top:5px solid var(--c)!important;border-radius:0 0 14px 14px!important;padding:16px 14px!important;background:transparent!important;min-height:84px;box-shadow:none!important;color:#051B5A!important;transition:none!important;transform:none!important;animation:none!important}\n.ss button.ss-tb-t i{width:34px!important;height:34px!important;flex:0 0 34px!important;border:2px solid var(--c)!important;background:#fff!important;color:var(--c)!important;font-size:15px!important;font-weight:700!important;transition:none!important;transform:none!important}\n.ss button.ss-tb-t b{font-size:15px!important;line-height:1.25!important;font-weight:600!important;color:inherit!important;text-decoration:none!important}\n.ss button.ss-tb-t:hover b{text-decoration:none!important}\n.ss button.ss-tb-t small{font-size:12px!important;color:#7A5B00!important;font-weight:600!important;margin-top:3px!important}\n.ss button.ss-tb-t:not(.is-on):hover{background:#FDF3D6!important}\n.ss button.ss-tb-t.is-on{background:#051B5A!important;color:#fff!important}\n.ss button.ss-tb-t.is-on b{color:#fff!important}\n.ss button.ss-tb-t.is-on i{background:#F2B705!important;border-color:#F2B705!important;color:#051B5A!important}\n.ss button.ss-tb-t.is-on small{color:#F2D27A!important}\n.ss-tb-p,.ss-tb-p.is-on{animation:none!important;background:#F7F5EF;border-radius:24px}\n.ss-tb-k{font-weight:600}\n\n\/* mobile refinements (07\/11\/2026) *\/\n.ss-cal time{background:#EEF1F8!important;color:#051B5A!important}.ss-cal .ss-pend time{background:#FFF3CC!important;color:#7A5A00!important}\n@media (max-width:767px){\n.ss-scard-n{grid-template-columns:1fr!important;gap:14px!important}.ss-scard{min-height:0!important}.ss-scard-in{padding-top:120px!important}\n.ss-tb{display:flex!important;overflow-x:auto;scroll-snap-type:x mandatory;gap:8px!important;padding-bottom:6px;margin-left:-20px;margin-right:-20px;padding-left:20px;padding-right:20px;scrollbar-width:none}\n.ss-tb::-webkit-scrollbar{display:none}\n.ss-tb{scroll-padding-left:20px;scroll-padding-right:20px}\n.ss button.ss-tb-t{flex:0 0 72%!important;scroll-snap-align:start;min-height:72px}\n}\n\n@media (min-width:768px) and (max-width:1024px){.ss-scards{grid-template-columns:1fr}.ss-scard{min-height:300px}}\n<\/style><div class=\"ss\" data-p=\"clin\"><section class=\"ss-sec ss-hero\"><div class=\"ss-in ss-hero-g\"><div class=\"ss-hero-t\"><p class=\"ss-crumb\"><a href=\"https:\/\/sobelconsult.com\/de\/\">Startseite<\/a> \u203a <a href=\"https:\/\/sobelconsult.com\/de\/home\/unsere-losungen-2\/\">L\u00f6sungen<\/a> \u203a <a href=\"https:\/\/sobelconsult.com\/de\/home\/unsere-losungen-2\/medizinprodukte\/\">Medizinprodukte<\/a> \u203a <a href=\"https:\/\/sobelconsult.com\/de\/our-solutions-brazil\/\">Brasilien<\/a> \u203a <span class=\"cur\">Klinische Bewertung<\/span><\/p><p class=\"ss-eye\">Klinische Evidenz \u00b7 Brasilien<\/p><h1 class=\"ss-h1\">Klinische Bewertung f\u00fcr die ANVISA, aufgebaut auf Ihrer vorhandenen <span>Evidenz<\/span><\/h1><p class=\"ss-lead\">Die ANVISA erwartet, dass Indikationen, Leistung und Sicherheit eines Medizinprodukts durch klinische Evidenz belegt sind. Wir erstellen und aktualisieren die klinische Bewertung f\u00fcr Ihr brasilianisches Dossier und bauen auf dem auf, was Sie bereits f\u00fcr die EU oder die USA haben.<\/p><div class=\"ss-btns\"><a class=\"ss-btn\" href=\"#footer-cta\">Erstberatung buchen<\/a><a class=\"ss-more\" href=\"https:\/\/sobelconsult.com\/de\/home\/unsere-losungen-2\/\">Finden Sie Ihren regulatorischen Weg \u2192<\/a><\/div><ul class=\"ss-seals\"><li><i>\ud83c\udfc6<\/i>Top Medical Device Regulatory Consultant \u00b7 LatAm 2025<\/li><li><i>\u2713<\/i>ISO 9001 zertifiziert in Brasilien<\/li><li><i>\ud83c\udf10<\/i>Betreuung auf PT \u00b7 EN \u00b7 DE<\/li><\/ul><\/div><div class=\"ss-hero-p\"><img fetchpriority=\"high\" width=\"800\" height=\"605\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/6b24b715-4e1f-4135-970b-369cd460f364-1024x775.png\" class=\"ss-photo\" alt=\"Klinische Fachkraft pr\u00fcft Studienberichte neben einem sterilen Medizinprodukt\" loading=\"eager\" fetchpriority=\"high\" decoding=\"async\" data-no-lazy=\"1\" sizes=\"(max-width: 1024px) 100vw, 600px\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/6b24b715-4e1f-4135-970b-369cd460f364-1024x775.png 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/6b24b715-4e1f-4135-970b-369cd460f364-300x227.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/6b24b715-4e1f-4135-970b-369cd460f364-768x581.png 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/6b24b715-4e1f-4135-970b-369cd460f364.png 1184w\" \/><\/div><\/div><\/section><section class=\"ss-sec ss-white\" id=\"ss-who\"><div class=\"ss-in\"><div class=\"ss-head ss-c\"><p class=\"ss-eye\">Passt das zu Ihnen?<\/p><h2 class=\"ss-h2\">F\u00fcr wen wir das tun<\/h2><\/div><div class=\"ss-g4\"><div class=\"ss-card\"><b>Registrierung Klasse III oder IV<\/b><span>Ihr ANVISA-Dossier braucht eine Zusammenfassung der klinischen Evidenz.<\/span><\/div><div class=\"ss-card\"><b>CE- oder FDA-Unterlagen vorhanden<\/b><span>Sie haben einen Bericht \u00fcber die klinische Bewertung oder klinische Daten, die angepasst werden sollen.<\/span><\/div><div class=\"ss-card\"><b>Nachforderung der ANVISA<\/b><span>Die ANVISA hat Fragen zur klinischen Evidenz in Ihrer Einreichung gestellt.<\/span><\/div><div class=\"ss-card\"><b>Neues Produkt oder neue Indikation<\/b><span>Sie brauchen eventuell neue klinische Daten. Wir helfen Ihnen zu entscheiden, ob eine Studie n\u00f6tig ist und was sie umfasst.<\/span><\/div><\/div><\/div><\/section><section class=\"ss-sec\" id=\"ss-get\"><div class=\"ss-in ss-split\"><div><p class=\"ss-eye\">Was Sie erhalten<\/p><h2 class=\"ss-h2\">Was Sie erhalten<\/h2><p class=\"ss-sub\">Eine klinische Bewertung, strukturiert f\u00fcr das ANVISA-Dossier.<\/p><ul class=\"ss-check\"><li>Plan der klinischen Bewertung mit Umfang und Protokoll f\u00fcr die Literaturrecherche<\/li><li>Bericht \u00fcber die klinische Bewertung: Literatur, eigene Daten und Erfahrungen nach dem Inverkehrbringen<\/li><li>Analyse vergleichbarer Produkte, wenn Sie sich auf deren Daten st\u00fctzen<\/li><li>Gap-Analyse Ihrer klinischen EU- oder FDA-Unterlagen f\u00fcr das brasilianische Dossier<\/li><li>Zusammenfassung der klinischen Evidenz f\u00fcr das Registrierungsdossier<\/li><li>Antworten auf Nachforderungen der ANVISA und Aktualisierungen nach \u00c4nderungen<\/li><\/ul><\/div><div class=\"ss-split-p\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"605\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-how-we-work-projects-1024x775.png\" class=\"ss-photo2\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-how-we-work-projects-1024x775.png 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-how-we-work-projects-300x227.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-how-we-work-projects-768x581.png 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-how-we-work-projects.png 1184w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/div><\/div><\/section><section class=\"ss-sec ss-white\" id=\"ss-own\"><div class=\"ss-in\"><div class=\"ss-head ss-c\"><h2 class=\"ss-h2\">Worauf die ANVISA achtet<\/h2><p class=\"ss-sub\">Die wichtigsten Punkte hinter dem klinischen Teil Ihres brasilianischen Dossiers. Wie sie gelten, h\u00e4ngt vom Produkt ab.<\/p><\/div><div class=\"ss-g4\"><div class=\"ss-card ss-bar\"><b>Klinische Evidenz f\u00fcr die Aussagen<\/b><span>Indikationen, Leistung und Sicherheit sollten durch relevante klinische Daten belegt sein.<\/span><\/div><div class=\"ss-card ss-bar\"><b>Literatur und eigene Daten<\/b><span>Die Bewertung verbindet in der Regel eine kritische Literaturauswertung mit Ihren eigenen klinischen Daten und Daten nach dem Inverkehrbringen, g\u00fcnstigen wie ung\u00fcnstigen, und wird aktuell gehalten.<\/span><\/div><div class=\"ss-card ss-bar\"><b>Wann eine Studie n\u00f6tig sein kann<\/b><span>Reichen vorhandene Daten nicht aus, etwa bei innovativen Produkten oder neuen Indikationen, kann eine klinische Pr\u00fcfung n\u00f6tig sein.<\/span><\/div><div class=\"ss-card ss-bar\"><b>Studien in Brasilien<\/b><span>Klinische Pr\u00fcfungen in Brasilien folgen den Verfahren der ANVISA und der Ethikkommissionen. Wir helfen Ihnen zu verstehen, was f\u00fcr Ihr Produkt gilt.<\/span><\/div><\/div><\/div><\/section><section class=\"ss-sec\" id=\"ss-how\"><div class=\"ss-in\"><div class=\"ss-head ss-c\"><p class=\"ss-eye\">So funktioniert es<\/p><\/div><ol class=\"ss-steps\"><li><span class=\"ss-num\">1<\/span><b>Analyse<\/b><span>Wir pr\u00fcfen das Produkt, seine Aussagen, seine Klasse und die vorhandenen klinischen Daten.<\/span><\/li><li><span class=\"ss-num\">2<\/span><b>Plan<\/b><span>Wir legen den Umfang, die Nutzung vergleichbarer Produkte und das Protokoll der Literaturrecherche fest.<\/span><\/li><li><span class=\"ss-num\">3<\/span><b>Bericht<\/b><span>Wir verfassen die Bewertung nach der RDC 848\/2024 und dem Leitfaden der ANVISA zur klinischen Bewertung.<\/span><\/li><li><span class=\"ss-num\">4<\/span><b>Einreichung und Aktualisierungen<\/b><span>Wir begleiten die Einreichung, beantworten Nachforderungen und aktualisieren den Bericht nach \u00c4nderungen.<\/span><\/li><\/ol><p class=\"ss-c ss-after\"><a class=\"ss-btn\" href=\"#footer-cta\">Expertenrat anfragen<\/a><\/p><\/div><\/section><section class=\"ss-sec ss-white\" id=\"ss-rel\"><div class=\"ss-in\"><div class=\"ss-head ss-c\"><p class=\"ss-eye\">Verwandte Themen<\/p><h2 class=\"ss-h2\">Weiterlesen<\/h2><\/div><div class=\"ss-g3\"><a class=\"ss-card ss-link\" href=\"https:\/\/sobelconsult.com\/de\/our-solutions-brazil\/\"><b>Medizinprodukte \u00b7 Brasilien<\/b><span>Klassen, Wege und der vollst\u00e4ndige ANVISA-Prozess.<\/span><em>\u2192<\/em><\/a><a class=\"ss-card ss-link\" href=\"https:\/\/sobelconsult.com\/de\/our-solutions-brazil\/brazilian-registration-holder\/\"><b>Registrierungsinhaber in Brasilien<\/b><span>Ein Inhaber \u00fcber unseren qualifizierten Partner, unabh\u00e4ngig von Ihren H\u00e4ndlern.<\/span><em>\u2192<\/em><\/a><a class=\"ss-card ss-link\" href=\"https:\/\/sobelconsult.com\/de\/home\/unsere-losungen-2\/produkt-haengt-bei-der-anvisa-fest\/\"><b>Produkt bei der ANVISA festgefahren?<\/b><span>Abgelehnte oder stockende Einreichungen, analysiert und beantwortet.<\/span><em>\u2192<\/em><\/a><\/div><\/div><\/section><div class=\"ss-why\">\t\t<div data-elementor-type=\"container\" data-elementor-id=\"46190\" class=\"elementor elementor-46190 elementor-46189\" data-elementor-post-type=\"elementor_library\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5fc3d48 e-flex e-con-boxed e-con e-parent\" data-id=\"5fc3d48\" data-element_type=\"container\" data-e-type=\"container\" id=\"why-sobel\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-629f752 sbw-native e-flex e-con-boxed e-con e-child\" data-id=\"629f752\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-f0eb2c5 e-con-full sbw-l e-flex e-con e-child\" data-id=\"f0eb2c5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a36dc14 elementor-widget elementor-widget-heading\" data-id=\"a36dc14\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Warum Sobel<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3c265d3 elementor-widget elementor-widget-heading\" data-id=\"3c265d3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Regulierung als <span class=\"sbw-gold\">Gesch\u00e4ftsentscheidung,<\/span> nicht als Checkliste.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-85f7a25 elementor-widget elementor-widget-text-editor\" data-id=\"85f7a25\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>An jedem Projekt arbeiten vier Fachbereiche im selben Team zusammen \u2013 von der ersten Entscheidung bis hin zur Zeit nach der Markteinf\u00fchrung.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a67f4ac e-con-full e-grid e-con e-child\" data-id=\"a67f4ac\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-693f1b5 e-con-full e-flex e-con e-child\" data-id=\"693f1b5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-85f3478 elementor-widget elementor-widget-heading\" data-id=\"85f3478\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Strategie<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-97525b9 elementor-widget elementor-widget-text-editor\" data-id=\"97525b9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Zun\u00e4chst werden die Klassifizierung und die Marktabfolge festgelegt. Die Wahl der richtigen Klasse vom ersten Tag an verhindert Nacharbeiten.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6495a0a e-con-full e-flex e-con e-child\" data-id=\"6495a0a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-836adaf elementor-widget elementor-widget-heading\" data-id=\"836adaf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Eigene Wissenschaft<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-67ceef1 elementor-widget elementor-widget-text-editor\" data-id=\"67ceef1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Biologische Beurteilung, klinische Bewertung und toxikologische Beurteilung durch unser eigenes Team f\u00fcr klinische Evidenz und Produktsicherheit.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-32f324f e-con-full e-flex e-con e-child\" data-id=\"32f324f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-42f4202 elementor-widget elementor-widget-heading\" data-id=\"42f4202\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Regulierung, f\u00fcnf M\u00e4rkte<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-af07af2 elementor-widget elementor-widget-text-editor\" data-id=\"af07af2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>ANVISA, die FDA, die EU-MDR, die MHRA und Health Canada haben sich untereinander abgestimmt.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-509c85a e-con-full e-flex e-con e-child\" data-id=\"509c85a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e1ba45f elementor-widget elementor-widget-heading\" data-id=\"e1ba45f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Technologie<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2c8184f elementor-widget elementor-widget-text-editor\" data-id=\"2c8184f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Ein engagiertes Technologieteam entwickelt die Arbeitsabl\u00e4ufe, die daf\u00fcr sorgen, dass jedes Projekt nachvollziehbar bleibt und termingerecht abgewickelt wird.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4d1d951 e-con-full sbw-card e-flex e-con e-child\" data-id=\"4d1d951\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-afde0f5 elementor-widget elementor-widget-text-editor\" data-id=\"afde0f5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>\u201eWir wissen, wie Auditoren denken, denn wir waren selbst einmal einer von ihnen.\u201c<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4b051b4 e-con-full e-flex e-con e-child\" data-id=\"4b051b4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ed4939a elementor-widget elementor-widget-image\" data-id=\"ed4939a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"300\" height=\"300\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait-300x300.webp\" class=\"attachment-medium size-medium wp-image-44765\" alt=\"\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait-300x300.webp 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait-150x150.webp 150w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait-768x768.webp 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/maik-endler-portrait.webp 800w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-0a86da7 e-con-full e-flex e-con e-child\" data-id=\"0a86da7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ea43503 elementor-widget elementor-widget-heading\" data-id=\"ea43503\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Maik Endler<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d696004 elementor-widget elementor-widget-heading\" data-id=\"d696004\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Gr\u00fcnder und Gesch\u00e4ftsf\u00fchrer<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7c430b7 elementor-widget elementor-widget-text-editor\" data-id=\"7c430b7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>Maschinenbauingenieur, in Deutschland ausgebildet<\/li><li>Ehemaliger BSI-Auditor (Benannte Stelle)<\/li><li>Branchenerfahrung bei Sirona (jetzt Dentsply Sirona)<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-87729bb elementor-align-left elementor-widget elementor-widget-button\" data-id=\"87729bb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/sobelconsult.com\/de\/home\/about-us\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Lernen Sie das Team kennen \u2192<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-446ce21 elementor-widget elementor-widget-html\" data-id=\"446ce21\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<style>.sbw-gold{color:#F2B705}.sbw-eye .elementor-heading-title{display:flex;align-items:center;gap:10px}.sbw-eye .elementor-heading-title:before{content:\"\";width:9px;height:9px;border-radius:50%;background:#F2B705;flex:none}.sbw-list ul{margin:0;padding-left:18px}.sbw-list li{margin:4px 0}.sbw-list li::marker{color:#F2B705}@media(max-width:1024px){.sbw-native > .sbw-l, .sbw-native > .sbw-card{width:100%!important}}<\/style>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<\/div><section class=\"ss-sec\" id=\"ss-faq\"><div class=\"ss-in ss-faqg\"><div><p class=\"ss-eye\">Fragen und Antworten<\/p><h2 class=\"ss-h2\">H\u00e4ufige Fragen<\/h2><p class=\"ss-rules\"><b>Auf dieser Seite zitierte Vorschriften:<\/b> RDC 848\/2024 \u00b7 RDC 751\/2022 \u00b7 RDC 837\/2023 \u00b7 IN 290\/2024 \u00b7 ANVISA-Leitfaden 31\/2020 \u00b7 ISO 14155<\/p><\/div><div class=\"ss-faq\"><details open><summary>K\u00f6nnen wir unseren EU-Bericht \u00fcber die klinische Bewertung nutzen?<\/summary><p>Ja, als Ausgangspunkt. Ihre EU- oder FDA-Daten k\u00f6nnen die brasilianische Bewertung st\u00fctzen, angepasst an die Erwartungen der ANVISA. Wir ordnen Ihren Bericht dem brasilianischen Dossier zu und erg\u00e4nzen, was fehlt, etwa die in Brasilien angegebenen Indikationen und die Kennzeichnung. F\u00fcr manche Produkte mit h\u00f6herem Risiko, die in bestimmten M\u00e4rkten bereits zugelassen sind, erlauben die ANVISA-Regeln, die Bewertung der ausl\u00e4ndischen Beh\u00f6rde zu ber\u00fccksichtigen; wir pr\u00fcfen, ob Ihr Produkt dies nutzen kann.<\/p><\/details><details><summary>Brauchen Produkte der Klasse I und II eine klinische Bewertung?<\/summary><p>Die Regeln zur klinischen Bewertung gelten f\u00fcr alle Klassen, eingereicht wird aber Unterschiedliches. Bei notifizierten Produkten bleibt die Dokumentation in der Regel beim Inhaber und wird vorgelegt, wenn die ANVISA sie anfordert. Bei registrierten Produkten ist eine Zusammenfassung der klinischen Evidenz Teil des Dossiers.<\/p><\/details><details><summary>Wann ist eine klinische Pr\u00fcfung in Brasilien n\u00f6tig?<\/summary><p>Wenn vorhandene Daten nicht ausreichen, um die Aussagen zu belegen. Studien in Brasilien folgen den Verfahren der ANVISA und der Ethikkommissionen, die je nach Produkt und Studie unterschiedlich sind. Wir bewerten Ihren Fall und helfen Ihnen, den Weg zu planen.<\/p><\/details><details><summary>Ver\u00f6ffentlicht die ANVISA einen Leitfaden zur klinischen Bewertung?<\/summary><p>Ja. Der Leitfaden der ANVISA beschreibt die Literaturrecherche, die Nutzung vergleichbarer Produkte und den Aufbau des Berichts. Wir wenden ihn zusammen mit den geltenden Regeln an.<\/p><\/details><details><summary>Wer erstellt die Bewertung?<\/summary><p>Unsere Fachleute f\u00fcr klinische Evidenz und Produktsicherheit, gemeinsam mit dem Regulatory-Team, das den Rest Ihres ANVISA-Dossiers vorbereitet.<\/p><\/details><\/div><\/div><\/section><\/div><script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"K\\u00f6nnen wir unseren EU-Bericht \\u00fcber die klinische Bewertung nutzen?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Ja, als Ausgangspunkt. Ihre EU- oder FDA-Daten k\\u00f6nnen die brasilianische Bewertung st\\u00fctzen, angepasst an die Erwartungen der ANVISA. Wir ordnen Ihren Bericht dem brasilianischen Dossier zu und erg\\u00e4nzen, was fehlt, etwa die in Brasilien angegebenen Indikationen und die Kennzeichnung. 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