{"id":86,"date":"2025-06-03T10:15:56","date_gmt":"2025-06-03T10:15:56","guid":{"rendered":"https:\/\/charming-hypatia.91-134-243-6.plesk.page\/?page_id=86"},"modified":"2025-06-03T10:15:56","modified_gmt":"2025-06-03T10:15:56","slug":"qara","status":"publish","type":"page","link":"https:\/\/circum.artei.fr\/?page_id=86","title":{"rendered":"QARA"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Our&nbsp;<strong>QARA team<\/strong>&nbsp;brings deep expertise in international regulatory frameworks to support your medical device approvals under MDR and other global requirements. We work closely with our clients to&nbsp;<strong>streamline the path to market<\/strong>, reduce time-to-approval, and ensure full compliance throughout the product lifecycle.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">We can be the legal manufacturer for your device or we can support you in your MDR registration and supply you with all the needed technical documentation.<\/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>Our Regulatory &amp; Quality Services include:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Regulatory strategy development<\/strong>&nbsp;tailored to your product and target markets<\/li>\n\n\n\n<li><strong>510(k) submissions<\/strong>&nbsp;for the U.S. FDA<\/li>\n\n\n\n<li><strong>CE Mark technical documentation<\/strong>&nbsp;under MDR<\/li>\n\n\n\n<li><strong>Authorized Representative services<\/strong>&nbsp;(EU \/ UK \/ Switzerland)<\/li>\n\n\n\n<li><strong>Clinical Evaluation Reports (CERs)<\/strong><\/li>\n\n\n\n<li><strong>Biological Evaluation Reports (BERs)<\/strong><\/li>\n\n\n\n<li><strong>Support for other international registrations<\/strong>&nbsp;(e.g. TGA, ANVISA, PMDA)<\/li>\n\n\n\n<li><strong>V&amp;V activities<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">We are also MDSAP certified, which gives you access to the&nbsp;<strong>Canadian market access<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In addition, we manage the&nbsp;<strong>validation of sterilization processes<\/strong>&nbsp;(EtO, Gamma, Beta) in full accordance with applicable ISO standards, supporting both validation and routine release phases.<\/p>\n\n\n\n<p class=\"has-medium-font-size wp-block-paragraph\"><\/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\"><strong><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-light-blue-color\">Our other services<\/mark><\/strong><\/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\">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\">Injection Moulding<\/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\">Laboratory<\/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\">Manufacturing<\/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>Our&nbsp;QARA team&nbsp;brings deep expertise in international regulatory frameworks to support your medical device approvals under MDR and other global requirements. We work closely with our clients to&nbsp;streamline the path to market, reduce time-to-approval, and ensure full compliance throughout the product lifecycle. We can be the legal manufacturer for your device or we can support you [&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-86","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/circum.artei.fr\/index.php?rest_route=\/wp\/v2\/pages\/86","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=86"}],"version-history":[{"count":0,"href":"https:\/\/circum.artei.fr\/index.php?rest_route=\/wp\/v2\/pages\/86\/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=86"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}