{"id":1884,"date":"2025-11-16T09:00:03","date_gmt":"2025-11-16T09:00:03","guid":{"rendered":"https:\/\/circumlifesciences.com\/?page_id=1884"},"modified":"2025-11-16T09:00:03","modified_gmt":"2025-11-16T09:00:03","slug":"qualitat-und-regulatorische-angelegenheiten-qara","status":"publish","type":"page","link":"https:\/\/circum.artei.fr\/?page_id=1884","title":{"rendered":"QUALIT\u00c4T UND REGULATORISCHE ANGELEGENHEITEN (QARA)"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Unser QARA-Team verf\u00fcgt \u00fcber tiefgehende Expertise in internationalen regulatorischen Rahmenbedingungen zur Unterst\u00fctzung der Zulassung Ihrer Medizinprodukte gem\u00e4\u00df MDR und weiteren globalen Anforderungen.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Wir arbeiten eng mit unseren Kunden zusammen, um den Weg zur Markteinf\u00fchrung zu vereinfachen, die Genehmigungszeiten zu verk\u00fcrzen und die vollst\u00e4ndige Konformit\u00e4t \u00fcber den gesamten Produktlebenszyklus sicherzustellen.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Wir k\u00f6nnen als legaler Hersteller Ihres Produkts fungieren oder Sie bei der MDR-Registrierung unterst\u00fctzen und alle notwendigen technischen Dokumente bereitstellen.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u200b<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"560\" height=\"414\" src=\"https:\/\/circum.artei.fr\/wp-content\/uploads\/2025\/07\/Quality-Regulatory-Affairs-1-1_edited.png.avif\" alt=\"\" class=\"wp-image-1460\" style=\"width:295px;height:auto\" srcset=\"https:\/\/circum.artei.fr\/wp-content\/uploads\/2025\/07\/Quality-Regulatory-Affairs-1-1_edited.png.avif 560w, https:\/\/circum.artei.fr\/wp-content\/uploads\/2025\/07\/Quality-Regulatory-Affairs-1-1_edited.png-300x222.jpg 300w\" sizes=\"auto, (max-width: 560px) 100vw, 560px\" \/><\/figure>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\"><strong>Unsere QARA-Dienstleistungen umfassen:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Entwicklung regulatorischer Strategien f\u00fcr Produkt und Zielm\u00e4rkte<\/li>\n\n\n\n<li>510(k)-Einreichungen bei der FDA<\/li>\n\n\n\n<li>CE-konforme technische Unterlagen gem\u00e4\u00df MDR<\/li>\n\n\n\n<li>Dienste als Bevollm\u00e4chtigter (EU\/UK\/Schweiz)<\/li>\n\n\n\n<li>Klinische Bewertungsberichte (CER)<\/li>\n\n\n\n<li>Biologische Bewertungsberichte (BER)<\/li>\n\n\n\n<li>Unterst\u00fctzung bei internationalen Registrierungen (z.B. TGA, ANVISA, PMDA)<\/li>\n\n\n\n<li>V&amp;V-Aktivit\u00e4ten<\/li>\n<\/ul>\n\n\n\n<p class=\"has-medium-font-size wp-block-paragraph\">Wir sind zudem MDSAP-zertifiziert, was den Zugang zum kanadischen Markt erm\u00f6glicht.<br>Wir \u00fcbernehmen auch die Validierung von Sterilisationsprozessen (EtO, Gamma, Beta) gem\u00e4\u00df ISO-Normen, inklusive Initial- und Routinefreigabe.<\/p>\n\n\n\n<div class=\"wp-block-columns alignfull has-titan-white-background-color has-background is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<p class=\"wp-block-paragraph\" style=\"font-size:28px\"><\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-cover\" style=\"min-height:200px;aspect-ratio:unset;\"><img loading=\"lazy\" decoding=\"async\" width=\"2560\" height=\"1707\" class=\"wp-block-cover__image-background wp-image-1258 size-full\" alt=\"\" src=\"https:\/\/circum.artei.fr\/wp-content\/uploads\/2025\/06\/Artist_Working_On_3D_Model_original_1203182-scaled-1.jpg\" style=\"object-position:48% 0%\" data-object-fit=\"cover\" data-object-position=\"48% 0%\" srcset=\"https:\/\/circum.artei.fr\/wp-content\/uploads\/2025\/06\/Artist_Working_On_3D_Model_original_1203182-scaled-1.jpg 2560w, https:\/\/circum.artei.fr\/wp-content\/uploads\/2025\/06\/Artist_Working_On_3D_Model_original_1203182-scaled-1-300x200.jpg 300w, https:\/\/circum.artei.fr\/wp-content\/uploads\/2025\/06\/Artist_Working_On_3D_Model_original_1203182-scaled-1-1024x683.jpg 1024w, https:\/\/circum.artei.fr\/wp-content\/uploads\/2025\/06\/Artist_Working_On_3D_Model_original_1203182-scaled-1-768x512.jpg 768w, https:\/\/circum.artei.fr\/wp-content\/uploads\/2025\/06\/Artist_Working_On_3D_Model_original_1203182-scaled-1-1536x1024.jpg 1536w, https:\/\/circum.artei.fr\/wp-content\/uploads\/2025\/06\/Artist_Working_On_3D_Model_original_1203182-scaled-1-2048x1366.jpg 2048w\" sizes=\"auto, (max-width: 2560px) 100vw, 2560px\" \/><span aria-hidden=\"true\" class=\"wp-block-cover__background has-background-dim\" style=\"background-color:#535b66\"><\/span><div class=\"wp-block-cover__inner-container is-layout-constrained wp-block-cover-is-layout-constrained\">\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-fe48e5de wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-fill\"><a class=\"wp-block-button__link has-white-color has-light-blue-background-color has-text-color has-background has-link-color wp-element-button\" href=\"https:\/\/circum.artei.fr\/de\/design\/\">Design<\/a><\/div>\n<\/div>\n<\/div><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-cover is-light\" style=\"min-height:200px;aspect-ratio:unset;\"><img loading=\"lazy\" decoding=\"async\" width=\"683\" height=\"343\" class=\"wp-block-cover__image-background wp-image-732 size-full\" alt=\"\" src=\"https:\/\/circum.artei.fr\/wp-content\/uploads\/2025\/06\/Machine-1.png\" data-object-fit=\"cover\" srcset=\"https:\/\/circum.artei.fr\/wp-content\/uploads\/2025\/06\/Machine-1.png 683w, https:\/\/circum.artei.fr\/wp-content\/uploads\/2025\/06\/Machine-1-300x151.png 300w\" sizes=\"auto, (max-width: 683px) 100vw, 683px\" \/><span aria-hidden=\"true\" class=\"wp-block-cover__background has-background-dim\" style=\"background-color:#c0cec9\"><\/span><div class=\"wp-block-cover__inner-container is-layout-constrained wp-block-cover-is-layout-constrained\">\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-fe48e5de wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-white-color has-light-blue-background-color has-text-color has-background has-link-color wp-element-button\" href=\"https:\/\/circum.artei.fr\/de\/spritzguss\/\">Spritzguss<\/a><\/div>\n<\/div>\n<\/div><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-cover is-light\" style=\"min-height:200px;aspect-ratio:unset;\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"683\" class=\"wp-block-cover__image-background wp-image-154 size-large\" alt=\"\" src=\"https:\/\/circum.artei.fr\/wp-content\/uploads\/2025\/06\/Crystal_Structure_In_Petri_Dish_original_545123-1024x683.jpg\" data-object-fit=\"cover\" srcset=\"https:\/\/circum.artei.fr\/wp-content\/uploads\/2025\/06\/Crystal_Structure_In_Petri_Dish_original_545123-1024x683.jpg 1024w, https:\/\/circum.artei.fr\/wp-content\/uploads\/2025\/06\/Crystal_Structure_In_Petri_Dish_original_545123-300x200.jpg 300w, https:\/\/circum.artei.fr\/wp-content\/uploads\/2025\/06\/Crystal_Structure_In_Petri_Dish_original_545123-768x512.jpg 768w, https:\/\/circum.artei.fr\/wp-content\/uploads\/2025\/06\/Crystal_Structure_In_Petri_Dish_original_545123-1536x1024.jpg 1536w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><span aria-hidden=\"true\" class=\"wp-block-cover__background has-background-dim\" style=\"background-color:#9dbfc8\"><\/span><div class=\"wp-block-cover__inner-container is-layout-constrained wp-block-cover-is-layout-constrained\">\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-fe48e5de wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-fill\"><a class=\"wp-block-button__link has-white-color has-light-blue-background-color has-text-color has-background has-link-color wp-element-button\" href=\"https:\/\/circum.artei.fr\/de\/labor\/\">LABOR<\/a><\/div>\n<\/div>\n<\/div><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-cover is-light\" style=\"min-height:200px;aspect-ratio:unset;\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"683\" class=\"wp-block-cover__image-background wp-image-1710 size-large\" alt=\"\" src=\"https:\/\/circum.artei.fr\/wp-content\/uploads\/2025\/09\/Designer-2-1024x683.png\" data-object-fit=\"cover\" srcset=\"https:\/\/circum.artei.fr\/wp-content\/uploads\/2025\/09\/Designer-2-1024x683.png 1024w, https:\/\/circum.artei.fr\/wp-content\/uploads\/2025\/09\/Designer-2-300x200.png 300w, https:\/\/circum.artei.fr\/wp-content\/uploads\/2025\/09\/Designer-2-768x512.png 768w, https:\/\/circum.artei.fr\/wp-content\/uploads\/2025\/09\/Designer-2.png 1536w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><span aria-hidden=\"true\" class=\"wp-block-cover__background has-background-dim\" style=\"background-color:#8b8b8a\"><\/span><div class=\"wp-block-cover__inner-container is-layout-constrained wp-block-cover-is-layout-constrained\">\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-fe48e5de wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-white-color has-light-blue-background-color has-text-color has-background has-link-color wp-element-button\" href=\"https:\/\/circum.artei.fr\/de\/montage\/\">MONTAGE<\/a><\/div>\n<\/div>\n<\/div><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Unser QARA-Team verf\u00fcgt \u00fcber tiefgehende Expertise in internationalen regulatorischen Rahmenbedingungen zur Unterst\u00fctzung der Zulassung Ihrer Medizinprodukte gem\u00e4\u00df MDR und weiteren globalen Anforderungen. Wir arbeiten eng mit unseren Kunden zusammen, um den Weg zur Markteinf\u00fchrung zu vereinfachen, die Genehmigungszeiten zu verk\u00fcrzen und die vollst\u00e4ndige Konformit\u00e4t \u00fcber den gesamten Produktlebenszyklus sicherzustellen. Wir k\u00f6nnen als legaler Hersteller Ihres [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":147,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-1884","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/circum.artei.fr\/index.php?rest_route=\/wp\/v2\/pages\/1884","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/circum.artei.fr\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/circum.artei.fr\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/circum.artei.fr\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/circum.artei.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1884"}],"version-history":[{"count":0,"href":"https:\/\/circum.artei.fr\/index.php?rest_route=\/wp\/v2\/pages\/1884\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/circum.artei.fr\/index.php?rest_route=\/wp\/v2\/media\/147"}],"wp:attachment":[{"href":"https:\/\/circum.artei.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1884"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}