{"id":1841,"date":"2025-11-13T08:02:10","date_gmt":"2025-11-13T08:02:10","guid":{"rendered":"https:\/\/circumlifesciences.com\/?page_id=1841"},"modified":"2025-11-13T08:02:10","modified_gmt":"2025-11-13T08:02:10","slug":"qualite-et-affaires-reglementaires","status":"publish","type":"page","link":"https:\/\/circum.artei.fr\/?page_id=1841","title":{"rendered":"QUALITE ET AFFAIRES REGLEMENTAIRES"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Notre \u00e9quipe QARA<\/strong>&nbsp;(Qualit\u00e9 et Affaires R\u00e9glementaires) poss\u00e8de une expertise approfondie des cadres r\u00e9glementaires internationaux afin de soutenir l\u2019approbation de vos dispositifs m\u00e9dicaux selon le&nbsp;<strong>R\u00e8glement Europ\u00e9en MDR<\/strong>&nbsp;et d\u2019autres exigences mondiales.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nous travaillons en \u00e9troite collaboration avec nos clients pour&nbsp;<strong>simplifier le parcours vers la mise sur le march\u00e9<\/strong>,&nbsp;<strong>r\u00e9duire les d\u00e9lais d\u2019approbation<\/strong>&nbsp;et&nbsp;<strong>assurer la conformit\u00e9 totale<\/strong>&nbsp;tout au long du cycle de vie du produit.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nous pouvons agir en tant que&nbsp;<strong>fabricant l\u00e9gal<\/strong>&nbsp;de votre dispositif, ou bien&nbsp;<strong>vous accompagner dans votre enregistrement MDR<\/strong>&nbsp;en vous fournissant l\u2019ensemble de la&nbsp;<strong>documentation technique n\u00e9cessaire<\/strong>.<\/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>Nos services en Affaires R\u00e9glementaires et Qualit\u00e9 comprennent :<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Support pour les enregistrements internationaux<\/strong>&nbsp;(ex. TGA, ANVISA, PMDA)<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u00c9laboration d\u2019une&nbsp;<strong>strat\u00e9gie r\u00e9glementaire<\/strong>&nbsp;adapt\u00e9e \u00e0 votre produit et \u00e0 vos march\u00e9s cibles<\/li>\n\n\n\n<li><strong>D\u00e9p\u00f4ts 510(k)<\/strong>&nbsp;aupr\u00e8s de la&nbsp;<strong>FDA am\u00e9ricaine<\/strong><\/li>\n\n\n\n<li><strong>Dossiers techniques CE<\/strong>&nbsp;conformes au&nbsp;<strong>MDR europ\u00e9en<\/strong><\/li>\n\n\n\n<li><strong>Services de Repr\u00e9sentant Autoris\u00e9<\/strong>&nbsp;(UE \/ Royaume-Uni \/ Suisse)<\/li>\n\n\n\n<li><strong>Rapports d\u2019\u00e9valuation clinique (CER)<\/strong><\/li>\n\n\n\n<li><strong><strong>Rapports d\u2019\u00e9valuation biologique (BER)<\/strong><\/strong><\/li>\n\n\n\n<li><strong>Support pour les enregistrements internationaux<\/strong>&nbsp;(ex. TGA, ANVISA, PMDA)<\/li>\n\n\n\n<li><strong><strong>Activit\u00e9s de v\u00e9rification et validation (V&amp;V) <\/strong><\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Nous sommes \u00e9galement&nbsp;<strong>certifi\u00e9s MDSAP<\/strong>, ce qui vous ouvre l\u2019acc\u00e8s au&nbsp;<strong>march\u00e9 canadien<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">De plus, nous prenons en charge la&nbsp;<strong>validation des proc\u00e9d\u00e9s de st\u00e9rilisation<\/strong>&nbsp;(EtO, Gamma, B\u00eata) en stricte conformit\u00e9 avec les&nbsp;<strong>normes ISO applicables<\/strong>, en assurant \u00e0 la fois les phases de&nbsp;<strong>validation initiale<\/strong>&nbsp;et de&nbsp;<strong>lib\u00e9ration de routine<\/strong>.<\/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\">Nos autres 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\" href=\"https:\/\/circum.artei.fr\/fr\/conception\/\">CONCEPTION<\/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\/fr\/moulage-par-injection\/\">MOULAGE PAR INJECTION<\/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\/fr\/laboratoire\/\">LaboratoIRE<\/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\/fr\/assemblage\/\">ASSEMBLAGE<\/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>Notre \u00e9quipe QARA&nbsp;(Qualit\u00e9 et Affaires R\u00e9glementaires) poss\u00e8de une expertise approfondie des cadres r\u00e9glementaires internationaux afin de soutenir l\u2019approbation de vos dispositifs m\u00e9dicaux selon le&nbsp;R\u00e8glement Europ\u00e9en MDR&nbsp;et d\u2019autres exigences mondiales. Nous travaillons en \u00e9troite collaboration avec nos clients pour&nbsp;simplifier le parcours vers la mise sur le march\u00e9,&nbsp;r\u00e9duire les d\u00e9lais d\u2019approbation&nbsp;et&nbsp;assurer la conformit\u00e9 totale&nbsp;tout au long du [&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-1841","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/circum.artei.fr\/index.php?rest_route=\/wp\/v2\/pages\/1841","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=1841"}],"version-history":[{"count":0,"href":"https:\/\/circum.artei.fr\/index.php?rest_route=\/wp\/v2\/pages\/1841\/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=1841"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}