{"id":2057,"date":"2026-02-01T16:49:08","date_gmt":"2026-02-01T16:49:08","guid":{"rendered":"https:\/\/circumlifesciences.com\/?page_id=2057"},"modified":"2026-02-01T16:49:08","modified_gmt":"2026-02-01T16:49:08","slug":"qualita-e-affari-regolatori-qara","status":"publish","type":"page","link":"https:\/\/circum.artei.fr\/?page_id=2057","title":{"rendered":"QUALIT\u00c0 E AFFARI REGOLATORI (QARA)"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Il nostro team&nbsp;<strong>QARA (Qualit\u00e0 e Affari Regolatori)<\/strong>&nbsp;possiede una profonda esperienza nei quadri normativi internazionali per supportare l\u2019approvazione dei tuoi dispositivi medici secondo il Regolamento Europeo MDR e altri requisiti globali.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Lavoriamo a stretto contatto con i clienti per semplificare il percorso verso il mercato, ridurre i tempi di approvazione e garantire piena conformit\u00e0 durante tutto il ciclo di vita del prodotto.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Possiamo agire come produttore legale del tuo dispositivo o supportarti nella registrazione MDR fornendo tutta la documentazione tecnica necessaria.<\/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><strong>I nostri servizi QARA includono:<\/strong><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Sviluppo di una strategia regolatoria personalizzata per il tuo prodotto e i mercati target<\/li>\n\n\n\n<li>Depositi 510(k) presso la FDA statunitense<\/li>\n\n\n\n<li>Dossier tecnici CE conformi al MDR europeo<\/li>\n\n\n\n<li>Servizi di Rappresentante Autorizzato (UE \/ Regno Unito \/ Svizzera)<\/li>\n\n\n\n<li>Rapporti di valutazione clinica (CER)<\/li>\n\n\n\n<li>Rapporti di valutazione biologica (BER)<\/li>\n\n\n\n<li>Supporto per registrazioni internazionali (es.\u00a0TGA, ANVISA, PMDA)<\/li>\n\n\n\n<li>Attivit\u00e0 di verifica e validazione (V&amp;V)<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Siamo certificati&nbsp;<strong>MDSAP<\/strong>, che apre l\u2019accesso al mercato canadese.<br>Inoltre, ci occupiamo della validazione dei processi di sterilizzazione (EtO, Gamma, Beta) in piena conformit\u00e0 con le norme ISO applicabili, assicurando sia la fase di validazione iniziale sia la liberazione di routine.<\/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\"><strong>Altri Servizi<\/strong><\/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\"><strong>Progettazione\u00a0<\/strong><\/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\"><strong>Stampaggio a iniezione<\/strong><\/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\"><strong>Laboratorio<\/strong><\/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\"><strong>Produzione<\/strong><\/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>Il nostro team&nbsp;QARA (Qualit\u00e0 e Affari Regolatori)&nbsp;possiede una profonda esperienza nei quadri normativi internazionali per supportare l\u2019approvazione dei tuoi dispositivi medici secondo il Regolamento Europeo MDR e altri requisiti globali. Lavoriamo a stretto contatto con i clienti per semplificare il percorso verso il mercato, ridurre i tempi di approvazione e garantire piena conformit\u00e0 durante tutto [&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-2057","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/circum.artei.fr\/index.php?rest_route=\/wp\/v2\/pages\/2057","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=2057"}],"version-history":[{"count":0,"href":"https:\/\/circum.artei.fr\/index.php?rest_route=\/wp\/v2\/pages\/2057\/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=2057"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}