{"id":46407,"date":"2026-10-27T13:35:37","date_gmt":"2026-10-27T16:35:37","guid":{"rendered":"https:\/\/sobelconsult.com\/?page_id=46407"},"modified":"2026-10-27T13:35:40","modified_gmt":"2026-10-27T16:35:40","slug":"regulatory-qualitaet","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/de\/regulatory-qualitaet\/","title":{"rendered":"Regulatory &#038; Qualit\u00e4t"},"content":{"rendered":"<style id=\"sobel-pl-css\">\/* Sobel service page model (Blueprint 26\/10\/2026) *\/\n.ss{overflow-x:clip;background:#FAF7F2;color:#2B2E34;font-family:'Host Grotesk',system-ui,sans-serif}\n.ss *{box-sizing:border-box}\n.ss-sec{padding:64px 0;scroll-margin-top:74px;background:#FAF7F2}\n.ss-white{background:#fff}\n.ss-in{width:100%;max-width:1264px;margin:0 auto;padding:0 32px}\n.ss-crumb{margin:0 0 24px;font-size:13px;line-height:18px;font-weight:500;color:#4F535B}\n.ss-crumb a{color:#4F535B!important;text-decoration:none!important;font-weight:500;font-size:13px}.ss-crumb 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(max-width:1024px){.pl-crossg{grid-template-columns:1fr;gap:28px}}\n#pl-chain .ss-head{margin-bottom:26px}\n.pl-cpanel{padding:24px 28px}\n.pl-seg{margin-bottom:18px}\n@media (min-width:1025px) and (max-height:840px){.pl-hint{display:none}.pl-need .pl-panel{padding:20px 22px}}\n<\/style><div class=\"ss pl\" data-p=\"rq\"><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 <span class=\"cur\">Regulatory &amp; Qualit\u00e4t<\/span><\/p><p class=\"ss-eye\">Regulatory &amp; Qualit\u00e4t<\/p><h1 class=\"ss-h1\">Marktzugang und ein Qualit\u00e4tsmanagementsystem, das im Audit <span>besteht<\/span>.<\/h1><p class=\"ss-lead\">Zulassung, Qualit\u00e4tsmanagement, Risikomanagement und Audits gemeinsam geplant, damit die Arbeit f\u00fcr einen Markt zur Grundlage f\u00fcr den n\u00e4chsten wird.<\/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=\"645\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-regulatory-quality-audit-1024x825.jpg\" class=\"ss-photo\" alt=\"Qualit\u00e4tsexpertin pr\u00fcft die Dokumentation eines Medizinprodukts in einer Produktionsst\u00e4tte\" 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\/sobel-regulatory-quality-audit-1024x825.jpg 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-regulatory-quality-audit-300x242.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-regulatory-quality-audit-768x619.jpg 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-regulatory-quality-audit-1536x1237.jpg 1536w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-regulatory-quality-audit.jpg 1600w\" \/><\/div><\/div><\/section><section class=\"ss-sec ss-white\" id=\"pl-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>Erste Zulassung<\/b><span>Sie brauchen Klassifizierung, Strategie und ein Qualit\u00e4tsmanagementsystem, das die Beh\u00f6rde akzeptiert.<\/span><\/div><div class=\"ss-card\"><b>System aufbauen oder anpassen<\/b><span>Ihr System deckt ISO 13485, MDSAP, ANVISA-GMP oder die FDA QMSR noch nicht ab.<\/span><\/div><div class=\"ss-card\"><b>Audit oder Inspektion steht an<\/b><span>Sie m\u00f6chten das System pr\u00fcfen, bevor Zertifizierer oder Inspektoren kommen.<\/span><\/div><div class=\"ss-card\"><b>Lieferanten qualifizieren<\/b><span>Sie m\u00fcssen Lieferanten in Brasilien oder im Ausland auditieren.<\/span><\/div><\/div><\/div><\/section><section class=\"ss-sec pl-numsec\" id=\"pl-numbers\"><div class=\"ss-in\"><div class=\"ss-head ss-c\"><p class=\"ss-eye\">In Zahlen<\/p><h2 class=\"ss-h2\">Wo Qualit\u00e4t gepr\u00fcft wird<\/h2><\/div><div class=\"pl-nums\"><div class=\"pl-num\"><b>31.215<\/b><strong>ISO-13485-Zertifikate weltweit<\/strong><span>an 43.957 zertifizierten Standorten. Sie sind die h\u00e4ufigste Grundlage, um ein Qualit\u00e4tsmanagementsystem f\u00fcr Medizinprodukte nachzuweisen.<\/span><\/div><div class=\"pl-num\"><b>31.426<\/b><strong>MDSAP-Audits durchgef\u00fchrt<\/strong><span>von 2018 bis Mai 2025, in 82 L\u00e4ndern. Ein Audit wird von den f\u00fcnf Beh\u00f6rden des Programms genutzt, darunter ANVISA, FDA und Health Canada.<\/span><\/div><div class=\"pl-num\"><b>Nr. 1<\/b><strong>CAPA ist der h\u00e4ufigste FDA-Befund<\/strong><span>279 von 2.660 Beobachtungen bei Inspektionen von Medizinprodukten im Haushaltsjahr 2025. Beschwerden (211) folgen.<\/span><\/div><\/div><p class=\"pl-src\">Quellen: ISO Survey 2024 (ISO); MDSAP Today, IMDRF, 2026; FDA, Inspection Observations, Haushaltsjahr 2025.<\/p><\/div><\/section><section class=\"ss-sec ss-white\" id=\"pl-need\"><div class=\"ss-in\"><div class=\"ss-head\"><p class=\"ss-eye\">Was brauchen Sie?<\/p><h2 class=\"ss-h2\">W\u00e4hlen Sie ein Thema und sehen Sie, was es meist umfasst<\/h2><\/div><div class=\"pl-need\" data-pl-tabs><div class=\"pl-list\" role=\"tablist\" aria-label=\"Was brauchen Sie?\"><button type=\"button\" role=\"tab\" class=\"pl-it on\" aria-selected=\"true\" aria-controls=\"pl-p-registration\" data-pl-t=\"registration\"><span class=\"pl-ic\"><svg width=\"22\" height=\"22\" viewBox=\"0 0 24 24\" aria-hidden=\"true\" fill=\"none\" stroke=\"#051B5A\" stroke-width=\"1.8\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M6 3h9l4 4v14H6z\"\/><path d=\"M14 3v5h5\"\/><path d=\"M9 14l2 2 4-4\"\/><\/svg><\/span><span><b>Zulassung und Marktzugang<\/b><small>ANVISA, EU, UK, FDA, Health Canada<\/small><\/span><em aria-hidden=\"true\">\u203a<\/em><\/button><button type=\"button\" role=\"tab\" class=\"pl-it\" aria-selected=\"false\" aria-controls=\"pl-p-quality-systems\" data-pl-t=\"quality-systems\"><span class=\"pl-ic\"><svg width=\"22\" height=\"22\" viewBox=\"0 0 24 24\" aria-hidden=\"true\" fill=\"none\" stroke=\"#051B5A\" stroke-width=\"1.8\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M12 3l7 3v6c0 4.5-3 7.5-7 9-4-1.5-7-4.5-7-9V6z\"\/><path d=\"M9 12l2 2 4-4\"\/><\/svg><\/span><span><b>Qualit\u00e4tsmanagementsysteme<\/b><small>ISO 13485, MDSAP, ANVISA-GMP, QMSR<\/small><\/span><em aria-hidden=\"true\">\u203a<\/em><\/button><button type=\"button\" role=\"tab\" class=\"pl-it\" aria-selected=\"false\" aria-controls=\"pl-p-risk-management\" data-pl-t=\"risk-management\"><span class=\"pl-ic\"><svg width=\"22\" height=\"22\" viewBox=\"0 0 24 24\" aria-hidden=\"true\" fill=\"none\" stroke=\"#051B5A\" stroke-width=\"1.8\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M12 3 2.5 20h19z\"\/><path d=\"M12 10v4\"\/><path d=\"M12 17h.01\"\/><\/svg><\/span><span><b>Risikomanagement<\/b><small>ISO 14971<\/small><\/span><em aria-hidden=\"true\">\u203a<\/em><\/button><button type=\"button\" role=\"tab\" class=\"pl-it\" aria-selected=\"false\" aria-controls=\"pl-p-audits\" data-pl-t=\"audits\"><span class=\"pl-ic\"><svg width=\"22\" height=\"22\" viewBox=\"0 0 24 24\" aria-hidden=\"true\" fill=\"none\" stroke=\"#051B5A\" stroke-width=\"1.8\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><rect x=\"6\" y=\"4\" width=\"12\" height=\"17\" rx=\"2\"\/><path d=\"M9 3h6v3H9z\"\/><path d=\"M9 13l2 2 4-4\"\/><\/svg><\/span><span><b>Audits<\/b><small>Interne, Lieferanten- und Probeaudits<\/small><\/span><em aria-hidden=\"true\">\u203a<\/em><\/button><button type=\"button\" role=\"tab\" class=\"pl-it\" aria-selected=\"false\" aria-controls=\"pl-p-training\" data-pl-t=\"training\"><span class=\"pl-ic\"><svg width=\"22\" height=\"22\" viewBox=\"0 0 24 24\" aria-hidden=\"true\" fill=\"none\" stroke=\"#051B5A\" stroke-width=\"1.8\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M2 9l10-5 10 5-10 5z\"\/><path d=\"M6 11v5c0 2 12 2 12 0v-5\"\/><path d=\"M22 9v6\"\/><\/svg><\/span><span><b>Schulungen<\/b><small>Inhouse, f\u00fcr Regulatory- und Qualit\u00e4tsteams<\/small><\/span><em aria-hidden=\"true\">\u203a<\/em><\/button><\/div><div class=\"pl-panels\"><div class=\"pl-panel\" role=\"tabpanel\" id=\"pl-p-registration\" data-pl-p=\"registration\"><span class=\"pl-anchor\" id=\"registration\"><\/span><h3 class=\"ss-h3\">Zulassung und Marktzugang<\/h3><p class=\"pl-d\">Klassifizierung, Marktstrategie und ein Dossier im Format jeder Beh\u00f6rde. Den Weg Ihres Produkts, Markt f\u00fcr Markt, zeigt das Tool Sobel Route.<\/p><div class=\"pl-cols\"><div><p class=\"pl-lbl\">Umfasst in der Regel<\/p><ul class=\"ss-check\"><li>Klassifizierung und regulatorischer Weg<\/li><li>Marktreihenfolge, die auf Vorhandenem aufbaut<\/li><li>Technisches Dossier im Format jeder Beh\u00f6rde<\/li><li>Begleitung von Beh\u00f6rdenanfragen<\/li><\/ul><\/div><div><p class=\"pl-lbl\">Referenzen<\/p><p class=\"pl-chips\"><span>RDC 751\/2022<\/span><span>EU MDR<\/span><span>FDA<\/span><span>Health Canada<\/span><\/p><\/div><\/div><p class=\"pl-act\"><a class=\"ss-more\" href=\"https:\/\/sobelconsult.com\/de\/home\/unsere-losungen-2\/\">Finden Sie Ihren regulatorischen Weg \u2192<\/a><\/p><\/div><div class=\"pl-panel\" role=\"tabpanel\" id=\"pl-p-quality-systems\" data-pl-p=\"quality-systems\" hidden><span class=\"pl-anchor\" id=\"quality-systems\"><\/span><h3 class=\"ss-h3\">Qualit\u00e4tsmanagementsysteme<\/h3><p class=\"pl-d\">Aufbau, Anpassung oder Integration Ihres Qualit\u00e4tsmanagementsystems, ausgelegt, um mehrere M\u00e4rkte von derselben Grundlage aus zu bedienen.<\/p><div class=\"pl-cols\"><div><p class=\"pl-lbl\">Umfasst in der Regel<\/p><ul class=\"ss-check\"><li>Bewertung Ihres aktuellen Systems<\/li><li>Handbuch, Verfahren und Aufzeichnungen<\/li><li>Integration mit dem Risikomanagement<\/li><li>Vorbereitung auf Zertifizierung oder Inspektion<\/li><\/ul><\/div><div><p class=\"pl-lbl\">Referenzen<\/p><p class=\"pl-chips\"><span>ISO 13485:2016<\/span><span>MDSAP<\/span><span>RDC 665\/2022<\/span><span>FDA QMSR<\/span><span>ISO 22716<\/span><\/p><\/div><\/div><p class=\"pl-act\"><a class=\"ss-more\" href=\"#footer-cta\">Sprechen Sie mit uns dar\u00fcber \u2192<\/a><\/p><\/div><div class=\"pl-panel\" role=\"tabpanel\" id=\"pl-p-risk-management\" data-pl-p=\"risk-management\" hidden><span class=\"pl-anchor\" id=\"risk-management\"><\/span><h3 class=\"ss-h3\">Risikomanagement<\/h3><p class=\"pl-d\">Ein Risikomanagementprozess, der das Produkt von der Entwicklung bis nach dem Inverkehrbringen begleitet und mit der \u00fcbrigen technischen Dokumentation verkn\u00fcpft ist.<\/p><div class=\"pl-cols\"><div><p class=\"pl-lbl\">Umfasst in der Regel<\/p><ul class=\"ss-check\"><li>Risikomanagementplan und -bericht<\/li><li>Risikoanalyse, zum Beispiel FMEA<\/li><li>Verkn\u00fcpfung mit Gebrauchstauglichkeit, Biokompatibilit\u00e4t und Marktbeobachtung<\/li><li>Pr\u00fcfung bestehender Unterlagen<\/li><\/ul><\/div><div><p class=\"pl-lbl\">Referenzen<\/p><p class=\"pl-chips\"><span>ISO 14971:2019<\/span><span>ISO\/TR 24971<\/span><\/p><\/div><\/div><p class=\"pl-act\"><a class=\"ss-more\" href=\"#footer-cta\">Sprechen Sie mit uns dar\u00fcber \u2192<\/a><\/p><\/div><div class=\"pl-panel\" role=\"tabpanel\" id=\"pl-p-audits\" data-pl-p=\"audits\" hidden><span class=\"pl-anchor\" id=\"audits\"><\/span><h3 class=\"ss-h3\">Audits<\/h3><p class=\"pl-d\">Audits von Menschen, die die andere Seite des Tisches kennen. Vor Ort, remote oder hybrid, f\u00fcr Medizinprodukte und Kosmetik.<\/p><div class=\"pl-cols\"><div><p class=\"pl-lbl\">Umfasst in der Regel<\/p><ul class=\"ss-check\"><li>Internes Audit des Qualit\u00e4tsmanagementsystems<\/li><li>Lieferantenqualifizierung und -audits<\/li><li>Probeaudit vor Zertifizierung oder Inspektion<\/li><li>Bericht mit Abweichungen und Priorit\u00e4ten<\/li><\/ul><\/div><div><p class=\"pl-lbl\">Referenzen<\/p><p class=\"pl-chips\"><span>ISO 19011<\/span><span>ISO 13485<\/span><span>MDSAP<\/span><span>RDC 665\/2022<\/span><span>ISO 22716<\/span><\/p><\/div><\/div><p class=\"pl-act\"><a class=\"ss-more\" href=\"#footer-cta\">Sprechen Sie mit uns dar\u00fcber \u2192<\/a><\/p><\/div><div class=\"pl-panel\" role=\"tabpanel\" id=\"pl-p-training\" data-pl-p=\"training\" hidden><span class=\"pl-anchor\" id=\"training\"><\/span><h3 class=\"ss-h3\">Schulungen<\/h3><p class=\"pl-d\">Ma\u00dfgeschneiderte Schulungen mit Ihren eigenen Dokumenten und F\u00e4llen, damit das Team sie am n\u00e4chsten Tag anwenden kann.<\/p><div class=\"pl-cols\"><div><p class=\"pl-lbl\">Umfasst in der Regel<\/p><ul class=\"ss-check\"><li>Inhouse-Schulung<\/li><li>Live online<\/li><li>Workshops mit Ihren Dokumenten<\/li><\/ul><\/div><div><p class=\"pl-lbl\">Referenzen<\/p><p class=\"pl-chips\"><span>ISO 13485<\/span><span>ISO 14971<\/span><span>EU MDR<\/span><span>RDC 665\/2022<\/span><\/p><\/div><\/div><p class=\"pl-act\"><a class=\"ss-more\" href=\"#footer-cta\">Sprechen Sie mit uns dar\u00fcber \u2192<\/a><\/p><\/div><\/div><\/div><p class=\"pl-hint\">Tippen Sie auf ein Thema, um Details zu sehen.<\/p><\/div><\/section><section class=\"ss-sec\" id=\"pl-markets\"><div class=\"ss-in\"><div class=\"ss-head\"><p class=\"ss-eye\">In jedem Markt<\/p><h2 class=\"ss-h2\">Die Qualit\u00e4tsreferenz, die jede Beh\u00f6rde meist nutzt<\/h2><p class=\"ss-sub\">Eine gut aufgebaute Grundlage dient meist mehreren M\u00e4rkten. Was sich \u00e4ndert, ist der Nachweis.<\/p><\/div><div class=\"pl-mk\" data-pl-tabs><div class=\"pl-mtabs\" role=\"tablist\"><button type=\"button\" role=\"tab\" class=\"pl-mt on\" aria-selected=\"true\" data-pl-t=\"mk-br\"><svg class=\"pl-flag\" viewBox=\"0 0 30 20\" width=\"24\" height=\"16\" aria-hidden=\"true\"><rect width=\"30\" height=\"20\" fill=\"#229E45\"\/><path d=\"M3 10 15 2 27 10 15 18Z\" fill=\"#F8E509\"\/><circle cx=\"15\" cy=\"10\" r=\"4.5\" fill=\"#2B49A3\"\/><\/svg><span>Brasilien<\/span><\/button><button type=\"button\" role=\"tab\" class=\"pl-mt\" aria-selected=\"false\" data-pl-t=\"mk-eu\"><svg class=\"pl-flag\" viewBox=\"0 0 30 20\" width=\"24\" height=\"16\" aria-hidden=\"true\"><rect width=\"30\" height=\"20\" fill=\"#003399\"\/><g fill=\"#FFCC00\"><circle cx=\"21.5\" cy=\"10\" r=\"1.2\"\/><circle cx=\"20.63\" cy=\"13.25\" r=\"1.2\"\/><circle cx=\"18.25\" cy=\"15.63\" r=\"1.2\"\/><circle cx=\"15\" cy=\"16.5\" r=\"1.2\"\/><circle cx=\"11.75\" cy=\"15.63\" r=\"1.2\"\/><circle cx=\"9.37\" cy=\"13.25\" r=\"1.2\"\/><circle cx=\"8.5\" cy=\"10\" r=\"1.2\"\/><circle cx=\"9.37\" cy=\"6.75\" r=\"1.2\"\/><circle cx=\"11.75\" cy=\"4.37\" r=\"1.2\"\/><circle cx=\"15\" cy=\"3.5\" r=\"1.2\"\/><circle cx=\"18.25\" cy=\"4.37\" r=\"1.2\"\/><circle cx=\"20.63\" cy=\"6.75\" r=\"1.2\"\/><\/g><\/svg><span>Europ\u00e4ische Union<\/span><\/button><button type=\"button\" role=\"tab\" class=\"pl-mt\" aria-selected=\"false\" data-pl-t=\"mk-uk\"><svg class=\"pl-flag\" viewBox=\"0 0 30 20\" width=\"24\" height=\"16\" aria-hidden=\"true\"><rect width=\"30\" height=\"20\" fill=\"#012169\"\/><path d=\"M0 0h4l26 17v3h-4L0 3Z M30 0v3L4 20H0v-3L26 0Z\" fill=\"#fff\"\/><path d=\"M11 0h8v20h-8Z M0 6h30v8H0Z\" fill=\"#fff\"\/><path d=\"M12.8 0h4.4v20h-4.4Z M0 7.8h30v4.4H0Z\" fill=\"#C8102E\"\/><\/svg><span>Vereinigtes K\u00f6nigreich<\/span><\/button><button type=\"button\" role=\"tab\" class=\"pl-mt\" aria-selected=\"false\" data-pl-t=\"mk-us\"><svg class=\"pl-flag\" viewBox=\"0 0 30 20\" width=\"24\" height=\"16\" aria-hidden=\"true\"><rect y=\"0\" width=\"30\" height=\"2.86\" fill=\"#B22234\"\/><rect y=\"2.86\" width=\"30\" height=\"2.86\" fill=\"#fff\"\/><rect y=\"5.71\" width=\"30\" height=\"2.86\" fill=\"#B22234\"\/><rect y=\"8.57\" width=\"30\" height=\"2.86\" fill=\"#fff\"\/><rect y=\"11.43\" width=\"30\" height=\"2.86\" fill=\"#B22234\"\/><rect y=\"14.29\" width=\"30\" height=\"2.86\" fill=\"#fff\"\/><rect y=\"17.14\" width=\"30\" height=\"2.86\" fill=\"#B22234\"\/><rect width=\"13\" height=\"11.43\" fill=\"#3C3B6E\"\/><\/svg><span>USA<\/span><\/button><button type=\"button\" role=\"tab\" class=\"pl-mt\" aria-selected=\"false\" data-pl-t=\"mk-ca\"><svg class=\"pl-flag\" viewBox=\"0 0 30 20\" width=\"24\" height=\"16\" aria-hidden=\"true\"><rect width=\"30\" height=\"20\" fill=\"#fff\"\/><rect width=\"7.5\" height=\"20\" fill=\"#D80621\"\/><rect x=\"22.5\" width=\"7.5\" height=\"20\" fill=\"#D80621\"\/><path d=\"M15 4l2 4 3-1-2 5h-2v4h-2v-4h-2l-2-5 3 1Z\" fill=\"#D80621\"\/><\/svg><span>Kanada<\/span><\/button><\/div><div class=\"pl-panel pl-mpanel\" role=\"tabpanel\" data-pl-p=\"mk-br\"><p class=\"pl-reg\"><svg class=\"pl-flag\" viewBox=\"0 0 30 20\" width=\"24\" height=\"16\" aria-hidden=\"true\"><rect width=\"30\" height=\"20\" fill=\"#229E45\"\/><path d=\"M3 10 15 2 27 10 15 18Z\" fill=\"#F8E509\"\/><circle cx=\"15\" cy=\"10\" r=\"4.5\" fill=\"#2B49A3\"\/><\/svg>Brasilien \u00b7 ANVISA<\/p><div class=\"pl-rows\"><div class=\"pl-row pl-rmd\"><p class=\"pl-lbl\">Medizinprodukte<\/p><p>ANVISA wendet eigene Gute Herstellungspraxis an (RDC 665\/2022). F\u00fcr Produkte der Klassen III und IV erfordert die Registrierung meist das ANVISA-GMP-Zertifikat (CBPF), und MDSAP-Berichte k\u00f6nnen diesen Prozess unterst\u00fctzen.<\/p><\/div><div class=\"pl-row pl-rcos\"><p class=\"pl-lbl\">Kosmetik<\/p><p>Gute Herstellungspraxis f\u00fcr Kosmetik (RDC 48\/2013).<\/p><\/div><\/div><\/div><div class=\"pl-panel pl-mpanel\" role=\"tabpanel\" data-pl-p=\"mk-eu\" hidden><p class=\"pl-reg\"><svg class=\"pl-flag\" viewBox=\"0 0 30 20\" width=\"24\" height=\"16\" aria-hidden=\"true\"><rect width=\"30\" height=\"20\" fill=\"#003399\"\/><g fill=\"#FFCC00\"><circle cx=\"21.5\" cy=\"10\" r=\"1.2\"\/><circle cx=\"20.63\" cy=\"13.25\" r=\"1.2\"\/><circle cx=\"18.25\" cy=\"15.63\" r=\"1.2\"\/><circle cx=\"15\" cy=\"16.5\" r=\"1.2\"\/><circle cx=\"11.75\" cy=\"15.63\" r=\"1.2\"\/><circle cx=\"9.37\" cy=\"13.25\" r=\"1.2\"\/><circle cx=\"8.5\" cy=\"10\" r=\"1.2\"\/><circle cx=\"9.37\" cy=\"6.75\" r=\"1.2\"\/><circle cx=\"11.75\" cy=\"4.37\" r=\"1.2\"\/><circle cx=\"15\" cy=\"3.5\" r=\"1.2\"\/><circle cx=\"18.25\" cy=\"4.37\" r=\"1.2\"\/><circle cx=\"20.63\" cy=\"6.75\" r=\"1.2\"\/><\/g><\/svg>Europ\u00e4ische Union \u00b7 EU MDR<\/p><div class=\"pl-rows\"><div class=\"pl-row pl-rmd\"><p class=\"pl-lbl\">Medizinprodukte<\/p><p>Die MDR verlangt vom Hersteller ein Qualit\u00e4tsmanagementsystem. ISO 13485 ist die am h\u00e4ufigsten genutzte harmonisierte Norm f\u00fcr den Nachweis, und die Benannte Stelle bewertet das System je nach Klasse und Verfahren.<\/p><\/div><div class=\"pl-row pl-rcos\"><p class=\"pl-lbl\">Kosmetik<\/p><p>Die Verordnung (EG) 1223\/2009 verlangt Gute Herstellungspraxis, und ISO 22716 ist die harmonisierte Referenz.<\/p><\/div><\/div><\/div><div class=\"pl-panel pl-mpanel\" role=\"tabpanel\" data-pl-p=\"mk-uk\" hidden><p class=\"pl-reg\"><svg class=\"pl-flag\" viewBox=\"0 0 30 20\" width=\"24\" height=\"16\" aria-hidden=\"true\"><rect width=\"30\" height=\"20\" fill=\"#012169\"\/><path d=\"M0 0h4l26 17v3h-4L0 3Z M30 0v3L4 20H0v-3L26 0Z\" fill=\"#fff\"\/><path d=\"M11 0h8v20h-8Z M0 6h30v8H0Z\" fill=\"#fff\"\/><path d=\"M12.8 0h4.4v20h-4.4Z M0 7.8h30v4.4H0Z\" fill=\"#C8102E\"\/><\/svg>Vereinigtes K\u00f6nigreich \u00b7 MHRA<\/p><div class=\"pl-rows\"><div class=\"pl-row pl-rmd\"><p class=\"pl-lbl\">Medizinprodukte<\/p><p>Das Vereinigte K\u00f6nigreich hat eigene Regeln f\u00fcr Medizinprodukte, angewendet von der MHRA. ISO 13485 ist meist die Grundlage des Systems, das von der UK Approved Body bewertet oder \u00fcber die Anerkennung der CE-Kennzeichnung akzeptiert wird, je nach Fall.<\/p><\/div><div class=\"pl-row pl-rcos\"><p class=\"pl-lbl\">Kosmetik<\/p><p>Die britischen Kosmetikregeln verlangen Gute Herstellungspraxis, und ISO 22716 ist meist die Referenz.<\/p><\/div><\/div><\/div><div class=\"pl-panel pl-mpanel\" role=\"tabpanel\" data-pl-p=\"mk-us\" hidden><p class=\"pl-reg\"><svg class=\"pl-flag\" viewBox=\"0 0 30 20\" width=\"24\" height=\"16\" aria-hidden=\"true\"><rect y=\"0\" width=\"30\" height=\"2.86\" fill=\"#B22234\"\/><rect y=\"2.86\" width=\"30\" height=\"2.86\" fill=\"#fff\"\/><rect y=\"5.71\" width=\"30\" height=\"2.86\" fill=\"#B22234\"\/><rect y=\"8.57\" width=\"30\" height=\"2.86\" fill=\"#fff\"\/><rect y=\"11.43\" width=\"30\" height=\"2.86\" fill=\"#B22234\"\/><rect y=\"14.29\" width=\"30\" height=\"2.86\" fill=\"#fff\"\/><rect y=\"17.14\" width=\"30\" height=\"2.86\" fill=\"#B22234\"\/><rect width=\"13\" height=\"11.43\" fill=\"#3C3B6E\"\/><\/svg>USA \u00b7 FDA<\/p><div class=\"pl-rows\"><div class=\"pl-row pl-rmd\"><p class=\"pl-lbl\">Medizinprodukte<\/p><p>Seit Februar 2026 \u00fcbernimmt die FDA-Verordnung f\u00fcr Qualit\u00e4tsmanagementsysteme (QMSR) ISO 13485:2016 per Verweis, mit einigen FDA-spezifischen Anforderungen.<\/p><\/div><div class=\"pl-row pl-rcos\"><p class=\"pl-lbl\">Kosmetik<\/p><p>MoCRA sieht GMP-Regeln der FDA f\u00fcr Kosmetik vor. Bis dahin ist ISO 22716 meist die Referenz.<\/p><\/div><\/div><\/div><div class=\"pl-panel pl-mpanel\" role=\"tabpanel\" data-pl-p=\"mk-ca\" hidden><p class=\"pl-reg\"><svg class=\"pl-flag\" viewBox=\"0 0 30 20\" width=\"24\" height=\"16\" aria-hidden=\"true\"><rect width=\"30\" height=\"20\" fill=\"#fff\"\/><rect width=\"7.5\" height=\"20\" fill=\"#D80621\"\/><rect x=\"22.5\" width=\"7.5\" height=\"20\" fill=\"#D80621\"\/><path d=\"M15 4l2 4 3-1-2 5h-2v4h-2v-4h-2l-2-5 3 1Z\" fill=\"#D80621\"\/><\/svg>Kanada \u00b7 Health Canada<\/p><div class=\"pl-rows\"><div class=\"pl-row pl-rmd\"><p class=\"pl-lbl\">Medizinprodukte<\/p><p>Health Canada verlangt f\u00fcr Lizenzen von Produkten der Klassen II, III und IV meist ein MDSAP-Zertifikat.<\/p><\/div><div class=\"pl-row pl-rcos\"><p class=\"pl-lbl\">Kosmetik<\/p><p>ISO 22716 ist meist die Referenz f\u00fcr gute Praxis bei Kosmetik.<\/p><\/div><\/div><\/div><p class=\"pl-note\">Die genaue Anforderung h\u00e4ngt vom Produkt, der Klasse und dem gew\u00e4hlten Weg ab. Wir best\u00e4tigen sie in Ihrer Erstberatung.<\/p><\/div><\/div><\/section><section class=\"ss-sec ss-white\" id=\"pl-how\"><div class=\"ss-in\"><div class=\"ss-head ss-c\"><p class=\"ss-eye\">So arbeiten wir<\/p><h2 class=\"ss-h2\">Von der Bestandsaufnahme zum Audit, in f\u00fcnf Schritten<\/h2><p class=\"ss-sub\">Sie verfolgen jeden Schritt im Sobel Client Workspace.<\/p><\/div><ol class=\"ss-steps pl-how\"><li><span class=\"ss-num\">1<\/span><b>Bestandsaufnahme<\/b><span>Wir betrachten Produkt, M\u00e4rkte und Ihr bestehendes System.<\/span><em class=\"pl-who\">Sobel<\/em><\/li><li><span class=\"ss-num\">2<\/span><b>Priorisierter Plan<\/b><span>Was zuerst kommt, f\u00fcr welchen Markt und mit welchem Aufwand.<\/span><em class=\"pl-who\">Sobel<\/em><\/li><li><span class=\"ss-num\">3<\/span><b>Umsetzung mit Ihrem Team<\/b><span>Dokumente, Prozesse und Schulung, im Tempo Ihres Unternehmens.<\/span><em class=\"pl-who\">Sobel und Sie<\/em><\/li><li><span class=\"ss-num\">4<\/span><b>Internes Audit oder Probeaudit<\/b><span>Wir pr\u00fcfen das System, bevor Zertifizierer oder Inspektoren kommen.<\/span><em class=\"pl-who\">Sobel<\/em><\/li><li><span class=\"ss-num\">5<\/span><b>Zertifizierung und Pflege<\/b><span>Begleitung im Audit oder in der Inspektion und bei den Folgema\u00dfnahmen.<\/span><em class=\"pl-who\">Sobel und Sie<\/em><\/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\" id=\"pl-cross\"><div class=\"ss-in pl-crossg\"><div class=\"pl-crossp\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"598\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-supplier-audit-1024x765.jpg\" class=\"ss-photo2\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-supplier-audit-1024x765.jpg 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-supplier-audit-300x224.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-supplier-audit-768x574.jpg 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-supplier-audit-1536x1147.jpg 1536w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/sobel-supplier-audit.jpg 1600w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/div><div><p class=\"ss-eye\">Von Anfang an gemeinsam<\/p><h2 class=\"ss-h2\">Regulatorische Strategie und Sicherheitsnachweise in einem Plan<\/h2><p class=\"ss-sub\">Viele Verz\u00f6gerungen beginnen, wenn regulatorische Strategie und Sicherheitsnachweise getrennt geplant werden. Bei Sobel arbeiten beide Teams am selben Dossier.<\/p><div class=\"pl-clist\"><a class=\"ss-card ss-link\" href=\"https:\/\/sobelconsult.com\/de\/klinische-evidenz-produktsicherheit\/\"><b>Klinische Evidenz &amp; Produktsicherheit<\/b><span>Biologische Beurteilung, Toxikologie und klinische Bewertung.<\/span><em>\u2192<\/em><\/a><a class=\"ss-card ss-link\" href=\"https:\/\/sobelconsult.com\/de\/home\/unsere-losungen-2\/\"><b>Sobel Route<\/b><span>Sehen Sie, was wir in jedem Markt tun, und stellen Sie Ihren Weg zusammen.<\/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 ANVISA blockiert?<\/b><span>Abgelehnt, mit Auflage oder ins Stocken geraten.<\/span><em>\u2192<\/em><\/a><\/div><\/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 und die IVDR, die MHRA sowie Health Canada haben ihre Ma\u00dfnahmen aufeinander 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 und Dentsply<\/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=\"pl-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> ISO 13485:2016 \u00b7 ISO 14971:2019 \u00b7 ISO 19011 \u00b7 ISO 22716 \u00b7 RDC 665\/2022 \u00b7 RDC 48\/2013 \u00b7 RDC 751\/2022 \u00b7 FDA QMSR \u00b7 MDSAP<\/p><\/div><div class=\"ss-faq\"><details open><summary>Stellt Sobel ISO-13485- oder MDSAP-Zertifikate aus?<\/summary><p>Nein. Die Zertifizierung erfolgt durch akkreditierte Zertifizierungsstellen oder, beim MDSAP, durch von den Beh\u00f6rden anerkannte Auditorganisationen. Sobel bereitet System, Dokumentation und Team auf dieses Audit vor.<\/p><\/details><details><summary>Kann ein einziges Qualit\u00e4tsmanagementsystem mehrere M\u00e4rkte bedienen?<\/summary><p>In der Regel ja. Eine ISO-13485-Grundlage ist meist der Ausgangspunkt, erg\u00e4nzt um die eigenen Anforderungen jeder Beh\u00f6rde. Was jeder Markt in Ihrem Fall verlangt, best\u00e4tigen wir in Ihrer Erstberatung.<\/p><\/details><details><summary>Auditieren Sie Lieferanten au\u00dferhalb Brasiliens?<\/summary><p>Ja. Audits k\u00f6nnen vor Ort, remote oder hybrid stattfinden, je nach Lieferant und Risiko.<\/p><\/details><details><summary>Arbeiten Sie mit Kosmetikherstellern?<\/summary><p>Ja. F\u00fcr Kosmetik arbeiten wir mit Guter Herstellungspraxis und ISO 22716 sowie mit Lieferantenaudits.<\/p><\/details><details><summary>In welchen Sprachen arbeiten Sie?<\/summary><p>Auf Portugiesisch, Englisch und Deutsch.<\/p><\/details><\/div><\/div><\/section><\/div><script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Stellt Sobel ISO-13485- oder MDSAP-Zertifikate aus?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Nein. Die Zertifizierung erfolgt durch akkreditierte Zertifizierungsstellen oder, beim MDSAP, durch von den Beh\\u00f6rden anerkannte Auditorganisationen. Sobel bereitet System, Dokumentation und Team auf dieses Audit vor.\"}},{\"@type\":\"Question\",\"name\":\"Kann ein einziges Qualit\\u00e4tsmanagementsystem mehrere M\\u00e4rkte bedienen?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"In der Regel ja. 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