{"id":9617,"date":"2017-11-09T18:07:01","date_gmt":"2017-11-09T18:07:01","guid":{"rendered":"http:\/\/www.fetaldna.it\/certificazioni\/"},"modified":"2022-03-06T22:29:14","modified_gmt":"2022-03-06T22:29:14","slug":"certifications-brevets","status":"publish","type":"page","link":"https:\/\/www.fetaldna.it\/fr\/certifications-brevets\/","title":{"rendered":"CERTIFICATIONS ET BREVETS"},"content":{"rendered":"

[vc_row full_width=”stretch_row” softing_row_overlay_type=”custom” softing_bg_attachment=”fixed” softing_lg_bgpos=”center” css=”.vc_custom_1641315874674{padding-top: 120px !important;padding-bottom: 120px !important;background-image: url(https:\/\/www.fetaldna.it\/wp-content\/uploads\/2021\/12\/Sfondo_Altamedica_grigio-1.png?id=13217) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}” softing_row_overlayclr=”rgba(242,72,62,0.4)”][vc_column][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” softing_row_prepad=”ptb-30″][vc_column][vc_custom_heading text=”CERTIFICATIONS ET BREVETS” font_container=”tag:h2|text_align:center” use_theme_fonts=”yes”][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” full_height=”yes”][vc_column][vc_column_text]<\/p>\n

Le laboratoire ALTAMEDICA, sp\u00e9cialis\u00e9 en G\u00e9n\u00e9tique avec un accent particulier sur la m\u00e9decine pr\u00e9natale, dispose de toutes les certifications qualit\u00e9 requises et recommand\u00e9es<\/h4>\n

[\/vc_column_text][vc_row_inner softing_row_prepad=”ptb-20″][vc_column_inner width=”1\/3″][vc_single_image image=”13066″ img_size=”large” alignment=”center”][vc_column_text]<\/p>\n

Label CE-IVD
\nTest pr\u00e9natal non invasif
\nFetalDNA Altamedica<\/p>\n

[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/3″][vc_single_image image=”13072″ img_size=”large” alignment=”center”][vc_column_text]<\/p>\n

Syst\u00e8me Qualit\u00e9 conforme \u00e0 la norme
\nUNI EN ISO 9001:2015
\nReg. 7662-A<\/p>\n

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Minist\u00e8re du d\u00e9veloppement \u00e9conomique –
\nBrevets nr 102018000005623 et
\nnr 102018000004527<\/p>\n

[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_column_text]FetalDNA est le seul test pr\u00e9natal sur l’ADN f\u0153tal circulant dans le sang maternel qui poss\u00e8de la certification europ\u00e9enne CE-IVD \u00e0 la fois pour le KIT et pour l’ensemble du WORKFLOW, comme soulign\u00e9 sur le site du Minist\u00e8re de la Sant\u00e9 – Espace Dispositifs M\u00e9dicaux.<\/strong><\/p>\n

Vous trouverez ci-dessous le point 4 de la fiche technique “DESCRIPTION GENERALE DE L’APPAREIL”:<\/strong><\/p>\n

FetalDNA est un d\u00e9pistage in vitro pr\u00e9natal non invasif bas\u00e9 sur l’analyse de l’ADN f\u0153tal circulant dans le sang maternel. Il utilise des m\u00e9thodologies de s\u00e9quen\u00e7age g\u00e9nomique de pointe.<\/em><\/p>\n

En utilisant ce test, il est possible d’analyser le cfNDA chez la femme enceinte et les trisomies des chromosomes 13, 18 et 21, le sexe f\u0153tal, l’aneuplo\u00efdie des chromosomes sexuels, l’aneuplo\u00efdie de tous les autres autosomes, l’\u00e9valuation des alt\u00e9rations structurelles li\u00e9es \u00e0 certains syndromes de microd\u00e9l\u00e9tion.<\/em><\/p><\/blockquote>\n

On peut dire que tous les tests disponibles aujourd’hui poss\u00e8dent une simple “d\u00e9claration de conformit\u00e9” partielle qui certifie seulement une partie du processus ou m\u00eame seulement le logiciel. Il est absolument important que le m\u00e9decin prescrive l’ex\u00e9cution de ce test car il est prot\u00e9g\u00e9 par une documentation compl\u00e8te, d\u00e9crivant toutes les proc\u00e9dures (du traitement de l’\u00e9chantillon \u00e0 la validation des r\u00e9sultats \u00e0 l’aide d’un logiciel exclusif).<\/p>\n

Quant au label CE-IVD pour les dispositifs de diagnostic in vitro, il indique clairement que “les dispositifs ne peuvent \u00eatre mis sur le march\u00e9 et\/ou mis en service que s’ils satisfont aux exigences pr\u00e9vues par la directive communautaire” (98\/79\/ CE). Celui-ci a ensuite \u00e9t\u00e9 modifi\u00e9, pour des pr\u00e9cisions formelles, par 2007\/47\/CE.<\/p>\n

R\u00e9cemment, le r\u00e8glement (UE) 2017\/746 du Parlement europ\u00e9en et du Conseil du 5 avril 2017, relatif aux dispositifs m\u00e9dicaux de diagnostic in vitro, abroge progressivement la directive 98\/79\/CE (toujours en vigueur aujourd’hui) et la d\u00e9cision 2010\/227\/ UE de la Commission et il les remplacera compl\u00e8tement d’ici 2023.[\/vc_column_text][vc_separator color=”custom” border_width=”2″ accent_color=”#f2483e” css=”.vc_custom_1641314343647{padding-top: 3% !important;}”][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” full_height=”yes”][vc_column][vc_custom_heading text=”BREVETS” font_container=”tag:h2|text_align:center” use_theme_fonts=”yes” css=”.vc_custom_1646605289308{padding-top: 3% !important;}”][vc_column_text]<\/p>\n

ALTAMEDICA dispose de 2 certifications CE-IVD pour son FetalDNA NIPT:<\/strong><\/h4>\n

– KIT FETALDNA<\/strong><\/h4>\n

– FETALDNA WORKFLOW NIPT CE-IVD POUR TOUTES LES ANEUPLOIDIES AUTOSOMIQUES ET SEXUELLES, LES MICROD\u00c9L\u00c9TIONS ET LES MALADIES MONOG\u00c9NIQUES<\/strong><\/h4>\n

La deuxi\u00e8me certification comprend une documentation d\u00e9taill\u00e9e partag\u00e9e avec le Minist\u00e8re Italien de la Sant\u00e9, d\u00e9crivant toute la proc\u00e9dure (du traitement de l’\u00e9chantillon \u00e0 la validation des r\u00e9sultats \u00e0 l’aide d’un logiciel exclusif).[\/vc_column_text][vc_column_text]<\/p>\n

\"Cercare<\/a><\/p>\n

[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

[vc_row full_width=”stretch_row” softing_row_overlay_type=”custom” softing_bg_attachment=”fixed” softing_lg_bgpos=”center” css=”.vc_custom_1641315874674{padding-top: 120px !important;padding-bottom: 120px !important;background-image: url(https:\/\/www.fetaldna.it\/wp-content\/uploads\/2021\/12\/Sfondo_Altamedica_grigio-1.png?id=13217) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}” softing_row_overlayclr=”rgba(242,72,62,0.4)”][vc_column][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” softing_row_prepad=”ptb-30″][vc_column][vc_custom_heading text=”CERTIFICATIONS ET BREVETS” font_container=”tag:h2|text_align:center” use_theme_fonts=”yes”][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” full_height=”yes”][vc_column][vc_column_text] Le laboratoire ALTAMEDICA, sp\u00e9cialis\u00e9 en G\u00e9n\u00e9tique avec un accent particulier sur la m\u00e9decine pr\u00e9natale, dispose de toutes les certifications qualit\u00e9 requises et recommand\u00e9es [\/vc_column_text][vc_row_inner softing_row_prepad=”ptb-20″][vc_column_inner width=”1\/3″][vc_single_image image=”13066″…<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"custom-page.php","meta":{"footnotes":""},"class_list":["post-9617","page","type-page","status-publish","hentry"," c-blog-1-item nt-post-class"],"yoast_head":"\nCertificazioni test DNA fetale - FetalDNA - Altamedica Roma<\/title>\n<meta name=\"description\" content=\"Elenco certificazioni di qualit\u00e0 per il Test del DNA fetale FetalDNA. 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