{"id":36066,"date":"2023-09-08T07:59:42","date_gmt":"2023-09-08T14:59:42","guid":{"rendered":"https:\/\/www.arenasolutions.com\/conformite-des-dispositifs-medicaux\/"},"modified":"2025-10-17T09:00:11","modified_gmt":"2025-10-17T16:00:11","slug":"conformite-des-dispositifs-medicaux","status":"publish","type":"page","link":"https:\/\/www.arenasolutions.com\/fr\/solutions\/compliance-management\/medical-devices\/","title":{"rendered":"Conformit\u00e9 des dispositifs m\u00e9dicaux"},"content":{"rendered":"<p>[et_pb_section fb_built=\u00a0\u00bb1&Prime; admin_label=\u00a0\u00bbhero section\u00a0\u00bb module_class=\u00a0\u00bbhero-section\u00a0\u00bb _builder_version=\u00a0\u00bb4.17.4&Prime; background_image=\u00a0\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Hero-solutions-medical-devices-1.jpg\u00a0\u00bb custom_padding=\u00a0\u00bb30px||30px||true|false\u00a0\u00bb background_last_edited=\u00a0\u00bbon|tablet\u00a0\u00bb background_image_tablet=\u00a0\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/dark-purple-background.jpg\u00a0\u00bb background_enable_image_tablet=\u00a0\u00bbon\u00a0\u00bb collapsed=\u00a0\u00bbon\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb title_text_tablet=\u00a0\u00bbdark-purple-background\u00a0\u00bb alt_tablet=\u00a0\u00bbDark Purple Background\u00a0\u00bb][et_pb_row column_structure=\u00a0\u00bb1_2,1_2&Prime; _builder_version=\u00a0\u00bb4.16&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_column type=\u00a0\u00bb1_2&Prime; _builder_version=\u00a0\u00bb4.16&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_text _builder_version=\u00a0\u00bb4.16&Prime; header_text_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb header_3_text_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb header_4_font=\u00a0\u00bbOpen Sans|600|||||||\u00a0\u00bb header_4_text_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb custom_margin=\u00a0\u00bb||0px||false|false\u00a0\u00bb custom_padding=\u00a0\u00bb||0px|||\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<h1>Conformit\u00e9 <br class=\"hidden-on-mobile\" \/>r\u00e9glementaire des <br class=\"hidden-on-mobile\" \/>dispositifs m\u00e9dicaux<\/h1>\n<p>[\/et_pb_text][et_pb_text _builder_version=\u00a0\u00bb4.16&Prime; header_4_text_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb custom_padding=\u00a0\u00bb0px|||||\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<h4>Simplifier la conformit\u00e9 FDA, MDR et ISO<\/h4>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00a0\u00bb1_2&Prime; _builder_version=\u00a0\u00bb4.16&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00a0\u00bb1&Prime; _builder_version=\u00a0\u00bb4.16&Prime; custom_padding=\u00a0\u00bb15px||55px|||\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_row _builder_version=\u00a0\u00bb4.16&Prime; custom_padding=\u00a0\u00bb||18px|||\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_column type=\u00a0\u00bb4_4&Prime; _builder_version=\u00a0\u00bb4.16&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_text _builder_version=\u00a0\u00bb4.18.0&Prime; header_2_text_align=\u00a0\u00bbcenter\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<h2 style=\"text-align: center;\" class=\"dark-green\"><span>ACC\u00c9L\u00c9RER LA PR\u00c9PARATION AUX R\u00c9GLEMENTATIONS ET AUX EXIGENCES<\/span><\/h2>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00a0\u00bb1_2,1_2&Prime; make_equal=\u00a0\u00bbon\u00a0\u00bb _builder_version=\u00a0\u00bb4.16&Prime; custom_margin=\u00a0\u00bb||50px||false|false\u00a0\u00bb custom_padding=\u00a0\u00bb||||false|false\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_column type=\u00a0\u00bb1_2&Prime; _builder_version=\u00a0\u00bb4.16&Prime; custom_css_main_element=\u00a0\u00bbdisplay: grid;\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_image src=\u00a0\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Med-Dev-Expedite-Readiness.jpg\u00a0\u00bb alt=\u00a0\u00bbMedical Device Compliance Safety\u00a0\u00bb title_text=\u00a0\u00bbMed-Dev-Expedite-Readiness\u00a0\u00bb align=\u00a0\u00bbcenter\u00a0\u00bb _builder_version=\u00a0\u00bb4.18.0&Prime; max_width=\u00a0\u00bb575px\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][\/et_pb_image][\/et_pb_column][et_pb_column type=\u00a0\u00bb1_2&Prime; _builder_version=\u00a0\u00bb4.16&Prime; custom_css_main_element=\u00a0\u00bbdisplay: grid;||align-items: center;\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_text _builder_version=\u00a0\u00bb4.16&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<p><span>Pour garantir la s\u00e9curit\u00e9 des patients, les fabricants de dispositifs m\u00e9dicaux doivent mettre en place et maintenir des syst\u00e8mes de qualit\u00e9 r\u00e9pondant aux exigences de conformit\u00e9 r\u00e9glementaire sp\u00e9cifi\u00e9es par la <a href=\"https:\/\/www.arenasolutions.com\/resources\/glossary\/fda-compliance\/\">FDA<\/a>, la <a href=\"https:\/\/www.arenasolutions.com\/resources\/glossary\/european-union-medical-device-regulation\/\">MDR de l&rsquo;UE<\/a>, l&rsquo;<a href=\"https:\/\/www.arenasolutions.com\/resources\/glossary\/iso\/\">ISO<\/a> et d&rsquo;autres organismes de r\u00e9glementation. Le respect de r\u00e9glementations telles que la partie\u00a0820 du titre\u00a021 du CFR de la FDA et la norme ISO\u00a013485 est essentiel \u00e0 la r\u00e9ussite de la mise sur le march\u00e9 de vos produits.<\/span><\/p>\n<p><span>Le logiciel QMS dans le cloud d&rsquo;Arena vous permet de mettre en place et de g\u00e9rer des <a href=\"https:\/\/www.arenasolutions.com\/fr\/solutions\/design-controls\/\">contr\u00f4les de conception<\/a> robustes. Il simplifie la gestion des proc\u00e9dures op\u00e9rationnelles normalis\u00e9es (SOP), des dossiers de conception (DHF), des dossiers de d\u00e9veloppement (DMR), des dossiers de formation et de l&rsquo;ensemble du dossier produit en reliant les donn\u00e9es produit et qualit\u00e9 tout au long des phases de d\u00e9veloppement et d&rsquo;introduction de nouveaux produits.<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00a0\u00bb1&Prime; admin_label=\u00a0\u00bbEXPLORE ARENA&rsquo;S COMPREHENSIVE PLM PLATFORM\u00a0\u00bb _builder_version=\u00a0\u00bb4.16&Prime; background_image=\u00a0\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/gray-bg-1.jpg\u00a0\u00bb custom_padding=\u00a0\u00bb26px||54px|||\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_row _builder_version=\u00a0\u00bb4.16&Prime; custom_padding=\u00a0\u00bb||0px|||\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_column type=\u00a0\u00bb4_4&Prime; _builder_version=\u00a0\u00bb4.16&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_text _builder_version=\u00a0\u00bb4.18.0&Prime; text_text_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb header_2_text_align=\u00a0\u00bbcenter\u00a0\u00bb header_2_text_color=\u00a0\u00bb#000000&Prime; text_orientation=\u00a0\u00bbcenter\u00a0\u00bb custom_margin=\u00a0\u00bb||0px|||\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<h2 class=\"dark-green\" style=\"text-align: center;\"><span style=\"color: #00890b;\">LA GESTION DE LA QUALIT\u00c9 DANS LE CLOUD SIMPLIFIE LA CONFORMIT\u00c9 R\u00c9GLEMENTAIRE<\/span><\/h2>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=\u00a0\u00bb4.16&Prime; custom_padding=\u00a0\u00bb16px||32px|||\u00a0\u00bb custom_css_main_element=\u00a0\u00bbmax-width: 1100px !important;\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_column type=\u00a0\u00bb4_4&Prime; _builder_version=\u00a0\u00bb4.16&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_text _builder_version=\u00a0\u00bb4.16&Prime; text_orientation=\u00a0\u00bbcenter\u00a0\u00bb module_alignment=\u00a0\u00bbcenter\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<p><span>L&rsquo;introduction sur le march\u00e9 d&rsquo;un <a href=\"https:\/\/www.arenasolutions.com\/fr\/medical-device\/\">dispositif m\u00e9dical s\u00fbr, conforme et innovant<\/a> n&rsquo;est pas une mince affaire. Pour y parvenir, les fabricants de dispositifs m\u00e9dicaux doivent coordonner leurs \u00e9quipes qualit\u00e9, ing\u00e9nierie et op\u00e9rations, ainsi que leurs partenaires de la cha\u00eene d&rsquo;approvisionnement.&nbsp;<\/span><span>Le logiciel de gestion de la qualit\u00e9 <a href=\"https:\/\/www.arenasolutions.com\/fr\/platform\/qms\/\">Arena QMS<\/a> vous fournit un syst\u00e8me unique de v\u00e9rit\u00e9 pour d\u00e9velopper et commercialiser des dispositifs m\u00e9dicaux, tout en \u00e9liminant les risques de non-conformit\u00e9.<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00a0\u00bb1_3,1_3,1_3&Prime; use_custom_gutter=\u00a0\u00bbon\u00a0\u00bb gutter_width=\u00a0\u00bb1&Prime; make_equal=\u00a0\u00bbon\u00a0\u00bb module_class=\u00a0\u00bbfive-column-boxes white-boxes-row\u00a0\u00bb _builder_version=\u00a0\u00bb4.16&Prime; max_width=\u00a0\u00bb1200px\u00a0\u00bb module_alignment=\u00a0\u00bbcenter\u00a0\u00bb custom_padding=\u00a0\u00bb6px||6px||true|false\u00a0\u00bb custom_css_main_element=\u00a0\u00bbmax-width: 990px !important;\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_column type=\u00a0\u00bb1_3&Prime; _builder_version=\u00a0\u00bb4.16&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_blurb image=\u00a0\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icon-QUALITY-TEAMS.svg\u00a0\u00bb alt=\u00a0\u00bbQuality Assurance icon\u00a0\u00bb _builder_version=\u00a0\u00bb4.27.4&Prime; header_font=\u00a0\u00bb|700|||||||\u00a0\u00bb header_text_align=\u00a0\u00bbcenter\u00a0\u00bb header_text_color=\u00a0\u00bb#00890b\u00a0\u00bb background_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb text_orientation=\u00a0\u00bbcenter\u00a0\u00bb height=\u00a0\u00bb100%\u00a0\u00bb custom_padding=\u00a0\u00bb30px|20px|30px|20px|true|true\u00a0\u00bb hover_enabled=\u00a0\u00bb0&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb title_text=\u00a0\u00bbIcon-QUALITY TEAMS\u00a0\u00bb sticky_enabled=\u00a0\u00bb0&Prime;]<\/p>\n<h4><span style=\"color: #00890b;\">LES \u00c9QUIPES D&rsquo;ASSURANCE<\/span><br \/><span style=\"color: #00890b;\">QUALIT\u00c9<\/span><\/h4>\n<p>suivent des <a href=\"https:\/\/www.arenasolutions.com\/fr\/solutions\/quality-management\/\">processus qualit\u00e9<\/a> en boucle ferm\u00e9e afin d&rsquo;am\u00e9liorer la tra\u00e7abilit\u00e9<\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][et_pb_column type=\u00a0\u00bb1_3&Prime; _builder_version=\u00a0\u00bb4.16&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_blurb image=\u00a0\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icon-Change-Analysts.svg\u00a0\u00bb alt=\u00a0\u00bbIcon-Change-Analysts\u00a0\u00bb _builder_version=\u00a0\u00bb4.27.4&Prime; header_font=\u00a0\u00bb|700|||||||\u00a0\u00bb header_text_align=\u00a0\u00bbcenter\u00a0\u00bb header_text_color=\u00a0\u00bb#00890b\u00a0\u00bb background_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb text_orientation=\u00a0\u00bbcenter\u00a0\u00bb height=\u00a0\u00bb100%\u00a0\u00bb custom_padding=\u00a0\u00bb30px|20px|30px|20px|true|true\u00a0\u00bb hover_enabled=\u00a0\u00bb0&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb sticky_enabled=\u00a0\u00bb0&Prime; title_text=\u00a0\u00bbIcon-Change-Analysts\u00a0\u00bb]<\/p>\n<h4><span style=\"color: #00890b;\">LES \u00c9QUIPES CHARG\u00c9ES<\/span><br \/><span style=\"color: #00890b;\">DE LA CONFORMIT\u00c9 R\u00c9GLEMENTAIRE<\/span><\/h4>\n<p>\u00e9tablissent des contr\u00f4les de conception stricts pour garantir la conformit\u00e9 r\u00e9glementaire<\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][et_pb_column type=\u00a0\u00bb1_3&Prime; _builder_version=\u00a0\u00bb4.16&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_blurb image=\u00a0\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icon-MGMT-Teams.svg\u00a0\u00bb alt=\u00a0\u00bbIcon-MGMT-Teams\u00a0\u00bb _builder_version=\u00a0\u00bb4.27.4&Prime; header_font=\u00a0\u00bb|700|||||||\u00a0\u00bb header_text_align=\u00a0\u00bbcenter\u00a0\u00bb header_text_color=\u00a0\u00bb#00890b\u00a0\u00bb background_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb text_orientation=\u00a0\u00bbcenter\u00a0\u00bb height=\u00a0\u00bb100%\u00a0\u00bb custom_padding=\u00a0\u00bb30px|20px|30px|20px|true|true\u00a0\u00bb hover_enabled=\u00a0\u00bb0&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb title_text=\u00a0\u00bbIcon-MGMT-Teams\u00a0\u00bb sticky_enabled=\u00a0\u00bb0&Prime;]<\/p>\n<h4><span style=\"color: #00890b;\">LES \u00c9QUIPES<\/span><br \/><span style=\"color: #00890b;\">DE GESTION<\/span><\/h4>\n<p>am\u00e9liorent le respect des <a href=\"https:\/\/www.arenasolutions.com\/fr\/solutions\/training-management\/\">dossiers de formation<\/a>, des proc\u00e9dures op\u00e9rationnelles normalis\u00e9es (SOP), etc.<\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00a0\u00bb1_3,1_3,1_3&Prime; use_custom_gutter=\u00a0\u00bbon\u00a0\u00bb gutter_width=\u00a0\u00bb1&Prime; make_equal=\u00a0\u00bbon\u00a0\u00bb module_class=\u00a0\u00bbfive-column-boxes white-boxes-row\u00a0\u00bb _builder_version=\u00a0\u00bb4.16&Prime; max_width=\u00a0\u00bb1200px\u00a0\u00bb module_alignment=\u00a0\u00bbcenter\u00a0\u00bb custom_padding=\u00a0\u00bb6px||6px||true|false\u00a0\u00bb custom_css_main_element=\u00a0\u00bbmax-width: 990px !important;\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_column type=\u00a0\u00bb1_3&Prime; _builder_version=\u00a0\u00bb4.16&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_blurb image=\u00a0\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icon-ENGINEERING-TEAMS.svg\u00a0\u00bb alt=\u00a0\u00bbengineering teams icon\u00a0\u00bb _builder_version=\u00a0\u00bb4.27.4&Prime; header_font=\u00a0\u00bb|700|||||||\u00a0\u00bb header_text_align=\u00a0\u00bbcenter\u00a0\u00bb header_text_color=\u00a0\u00bb#00890b\u00a0\u00bb background_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb text_orientation=\u00a0\u00bbcenter\u00a0\u00bb height=\u00a0\u00bb100%\u00a0\u00bb custom_padding=\u00a0\u00bb30px|20px|30px|20px|true|true\u00a0\u00bb hover_enabled=\u00a0\u00bb0&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb title_text=\u00a0\u00bbIcon-ENGINEERING TEAMS\u00a0\u00bb sticky_enabled=\u00a0\u00bb0&Prime;]<\/p>\n<h4><span style=\"color: #00890b;\">LES \u00c9QUIPES<br \/>TECHNIQUES<\/span><\/h4>\n<p><span>b\u00e9n\u00e9ficient d&rsquo;une meilleure visibilit\u00e9 pour am\u00e9liorer sans cesse la conformit\u00e9 des conceptions&nbsp;<\/span><\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][et_pb_column type=\u00a0\u00bb1_3&Prime; _builder_version=\u00a0\u00bb4.16&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_blurb image=\u00a0\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icon-Doc-Mgmt.svg\u00a0\u00bb alt=\u00a0\u00bbDocument Control icon\u00a0\u00bb _builder_version=\u00a0\u00bb4.27.4&Prime; header_font=\u00a0\u00bb|700|||||||\u00a0\u00bb header_text_align=\u00a0\u00bbcenter\u00a0\u00bb header_text_color=\u00a0\u00bb#00890b\u00a0\u00bb background_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb text_orientation=\u00a0\u00bbcenter\u00a0\u00bb height=\u00a0\u00bb100%\u00a0\u00bb custom_padding=\u00a0\u00bb30px|20px|30px|20px|true|true\u00a0\u00bb hover_enabled=\u00a0\u00bb0&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb title_text=\u00a0\u00bbIcon-Document Management\u00a0\u00bb sticky_enabled=\u00a0\u00bb0&Prime;]<\/p>\n<h4><span style=\"color: #00890b;\">LES \u00c9QUIPES DE<\/span><br \/><span style=\"color: #00890b;\"> CONTR\u00d4LE DES DOCUMENTS<\/span><\/h4>\n<p>peuvent se pr\u00e9parer aux audits internes, ISO, MDR ou <a href=\"https:\/\/www.arenasolutions.com\/resources\/articles\/fda-audit-tips\/\">FDA<\/a><\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][et_pb_column type=\u00a0\u00bb1_3&Prime; _builder_version=\u00a0\u00bb4.16&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_blurb image=\u00a0\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icons-EXECUTIVE-MANAGEMENT.svg\u00a0\u00bb alt=\u00a0\u00bbExecutive Icon\u00a0\u00bb _builder_version=\u00a0\u00bb4.27.4&Prime; header_font=\u00a0\u00bb|700|||||||\u00a0\u00bb header_text_align=\u00a0\u00bbcenter\u00a0\u00bb header_text_color=\u00a0\u00bb#00890b\u00a0\u00bb background_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb text_orientation=\u00a0\u00bbcenter\u00a0\u00bb height=\u00a0\u00bb100%\u00a0\u00bb custom_padding=\u00a0\u00bb30px|20px|30px|20px|true|true\u00a0\u00bb hover_enabled=\u00a0\u00bb0&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb title_text=\u00a0\u00bbIcons-EXECUTIVE MANAGEMENT\u00a0\u00bb sticky_enabled=\u00a0\u00bb0&Prime;]<\/p>\n<h4><span style=\"color: #00890b;\">LES \u00c9QUIPES DE DIRECTION<\/span><\/h4>\n<p>peuvent prendre de meilleures d\u00e9cisions afin d&rsquo;acc\u00e9l\u00e9rer la mise sur le march\u00e9<\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00a0\u00bb1&Prime; _builder_version=\u00a0\u00bb4.16&Prime; custom_padding=\u00a0\u00bb||60px|||\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_row _builder_version=\u00a0\u00bb4.16&Prime; custom_padding=\u00a0\u00bb||15px|||\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_column type=\u00a0\u00bb4_4&Prime; _builder_version=\u00a0\u00bb4.16&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_text admin_label=\u00a0\u00bbH2&Prime; _builder_version=\u00a0\u00bb4.18.0&Prime; header_2_text_align=\u00a0\u00bbcenter\u00a0\u00bb custom_margin=\u00a0\u00bb||17px|||\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<h2 style=\"text-align: center;\" class=\"dark-green\">DES PROCESSUS DE GESTION DE LA QUALIT\u00c9 COORDONN\u00c9S<\/h2>\n<p>[\/et_pb_text][et_pb_text admin_label=\u00a0\u00bbparagraph\u00a0\u00bb _builder_version=\u00a0\u00bb4.16&Prime; text_orientation=\u00a0\u00bbcenter\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<p><span>Dans un environnement r\u00e9glement\u00e9, la commercialisation de nouveaux produits conformes repose essentiellement sur la coordination des dossiers produit et qualit\u00e9. Le logiciel Cloud QMS d&rsquo;Arena offre une approche ax\u00e9e sur le produit qui relie les dossiers qualit\u00e9, formations, fournisseurs et audits \u00e0 l&rsquo;int\u00e9gralit\u00e9 de la nomenclature.<br \/><\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00a0\u00bb1_3,1_3,1_3&Prime; use_custom_gutter=\u00a0\u00bbon\u00a0\u00bb gutter_width=\u00a0\u00bb2&Prime; make_equal=\u00a0\u00bbon\u00a0\u00bb _builder_version=\u00a0\u00bb4.18.0&Prime; width=\u00a0\u00bb90%\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_column type=\u00a0\u00bb1_3&Prime; module_class=\u00a0\u00bbhover-copy-column red\u00a0\u00bb _builder_version=\u00a0\u00bb4.18.0&Prime; background_enable_color=\u00a0\u00bboff\u00a0\u00bb background_image=\u00a0\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/quality-process.jpg\u00a0\u00bb custom_padding=\u00a0\u00bb||||true|true\u00a0\u00bb background_last_edited=\u00a0\u00bbon|desktop\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb background__hover_enabled=\u00a0\u00bbon|hover\u00a0\u00bb background_color__hover=\u00a0\u00bb#dc5000&Prime; background_enable_color__hover=\u00a0\u00bbon\u00a0\u00bb][et_pb_text admin_label=\u00a0\u00bbPre-hover copy\u00a0\u00bb module_class=\u00a0\u00bbpre-hover-copy red\u00a0\u00bb _builder_version=\u00a0\u00bb4.19.0&Prime; header_2_text_align=\u00a0\u00bbcenter\u00a0\u00bb header_2_text_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb header_4_text_align=\u00a0\u00bbcenter\u00a0\u00bb header_4_text_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb width=\u00a0\u00bb100%\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<h4>OPTIMISATION <br \/>DES PROCESSUS QUALIT\u00c9<br \/>EN BOUCLE FERM\u00c9E<\/h4>\n<p>[\/et_pb_text][et_pb_text admin_label=\u00a0\u00bbHover copy\u00a0\u00bb module_class=\u00a0\u00bbhover-copy red\u00a0\u00bb _builder_version=\u00a0\u00bb4.18.0&Prime; text_text_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<ul>\n<li><span>Fournit un acc\u00e8s ais\u00e9 et une meilleure tra\u00e7abilit\u00e9 \u00e0 toutes les \u00e9quipes afin de simplifier l&rsquo;analyse des probl\u00e8mes et d&rsquo;acc\u00e9l\u00e9rer leur r\u00e9solution<\/span><\/li>\n<li><span>Relie les processus qualit\u00e9 et CAPA au dossier produit afin d&rsquo;identifier, d&rsquo;analyser et de r\u00e9soudre rapidement les probl\u00e8mes<\/span><\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00a0\u00bb1_3&Prime; module_class=\u00a0\u00bbhover-copy-column orange\u00a0\u00bb _builder_version=\u00a0\u00bb4.18.0&Prime; background_enable_color=\u00a0\u00bboff\u00a0\u00bb background_image=\u00a0\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/issue-resolution.jpg\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb background__hover_enabled=\u00a0\u00bbon|hover\u00a0\u00bb background_color__hover=\u00a0\u00bb#f99238&Prime; background_enable_color__hover=\u00a0\u00bbon\u00a0\u00bb][et_pb_text admin_label=\u00a0\u00bbPre-hover copy\u00a0\u00bb module_class=\u00a0\u00bbpre-hover-copy orange\u00a0\u00bb _builder_version=\u00a0\u00bb4.19.0&Prime; header_2_text_align=\u00a0\u00bbcenter\u00a0\u00bb header_2_text_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb header_4_text_align=\u00a0\u00bbcenter\u00a0\u00bb header_4_text_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb width=\u00a0\u00bb100%\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<h4>R\u00c9DUCTION DES RISQUES <br \/>D&rsquo;AUDITS <br \/>INTERNES ET EXTERNES<\/h4>\n<p>[\/et_pb_text][et_pb_text admin_label=\u00a0\u00bbHover copy\u00a0\u00bb module_class=\u00a0\u00bbhover-copy orange\u00a0\u00bb _builder_version=\u00a0\u00bb4.18.0&Prime; text_text_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<ul>\n<li><span>Relie et indexe l&rsquo;ensemble du dossier produit, y compris les dossiers de d\u00e9veloppement (DMR) et de conception (DHF) afin de faciliter les recherches<\/span><\/li>\n<li><span>R\u00e9duit le risque d&rsquo;infractions, notamment les lettres d&rsquo;avertissement et les observations sur le formulaire\u00a0483<\/span><\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00a0\u00bb1_3&Prime; module_class=\u00a0\u00bbhover-copy-column blue\u00a0\u00bb _builder_version=\u00a0\u00bb4.18.0&Prime; background_enable_color=\u00a0\u00bboff\u00a0\u00bb background_image=\u00a0\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/single-system-of-truth.jpg\u00a0\u00bb background_last_edited=\u00a0\u00bbon|desktop\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb background__hover_enabled=\u00a0\u00bbon|desktop\u00a0\u00bb background_color__hover=\u00a0\u00bb#7b7bc1&Prime; background_enable_color__hover=\u00a0\u00bbon\u00a0\u00bb][et_pb_text admin_label=\u00a0\u00bbPre-hover copy\u00a0\u00bb module_class=\u00a0\u00bbpre-hover-copy blue\u00a0\u00bb _builder_version=\u00a0\u00bb4.19.0&Prime; header_2_text_align=\u00a0\u00bbcenter\u00a0\u00bb header_2_text_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb header_4_text_align=\u00a0\u00bbcenter\u00a0\u00bb header_4_text_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb width=\u00a0\u00bb100%\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<h4>SIMPLIFICATION <br \/>DE LA VALIDATION <br \/>DES SYST\u00c8MES LOGICIELS<\/h4>\n<p>[\/et_pb_text][et_pb_text admin_label=\u00a0\u00bbHover copy\u00a0\u00bb module_class=\u00a0\u00bbhover-copy blue\u00a0\u00bb _builder_version=\u00a0\u00bb4.18.0&Prime; text_text_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<ul>\n<li><span>Envoie les r\u00e9sultats des tests de validation de chaque mise \u00e0 niveau de produit \u00e0 tous les abonn\u00e9s<\/span><\/li>\n<li><span>R\u00e9duit la dur\u00e9e et le co\u00fbt de l&rsquo;\u00e9laboration et de l&rsquo;ex\u00e9cution des cas de test<\/span><\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row module_class=\u00a0\u00bblocale-hide-cn\u00a0\u00bb _builder_version=\u00a0\u00bb4.20.0&Prime; custom_padding=\u00a0\u00bb29px||21px|||\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_column type=\u00a0\u00bb4_4&Prime; _builder_version=\u00a0\u00bb4.16&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_text _builder_version=\u00a0\u00bb4.16&Prime; text_orientation=\u00a0\u00bbcenter\u00a0\u00bb custom_margin=\u00a0\u00bb||5px||false|false\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<p><span>D\u00e9couvrez comment les sept principes de la gestion de la qualit\u00e9 ax\u00e9e sur le produit simplifient la conformit\u00e9 r\u00e9glementaire<\/span>.<\/p>\n<p>[\/et_pb_text][et_pb_button button_url=\u00a0\u00bbhttps:\/\/www.arenasolutions.com\/white-papers\/7-principles-qms\/\u00a0\u00bb button_text=\u00a0\u00bbEN SAVOIR PLUS\u00a0\u00bb button_alignment=\u00a0\u00bbcenter\u00a0\u00bb _builder_version=\u00a0\u00bb4.17.4&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00a0\u00bb1&Prime; admin_label=\u00a0\u00bbQuality Talk Video-Sanjay Banerjee\u00a0\u00bb _builder_version=\u00a0\u00bb4.19.0&Prime; background_image=\u00a0\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/dark-purple-background.jpg\u00a0\u00bb custom_padding=\u00a0\u00bb30px||30px||true|\u00a0\u00bb locked=\u00a0\u00bboff\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_row column_structure=\u00a0\u00bb1_3,2_3&Prime; use_custom_gutter=\u00a0\u00bbon\u00a0\u00bb gutter_width=\u00a0\u00bb1&Prime; make_equal=\u00a0\u00bbon\u00a0\u00bb _builder_version=\u00a0\u00bb4.16&Prime; custom_padding=\u00a0\u00bb0px||0px||true|false\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_column type=\u00a0\u00bb1_3&Prime; _builder_version=\u00a0\u00bb4.16&Prime; custom_padding=\u00a0\u00bb|40px|||false|false\u00a0\u00bb custom_padding_tablet=\u00a0\u00bb|0px|||false|false\u00a0\u00bb custom_padding_phone=\u00a0\u00bb\u00a0\u00bb custom_padding_last_edited=\u00a0\u00bbon|tablet\u00a0\u00bb custom_css_main_element=\u00a0\u00bbdisplay: grid;||align-content: center;\u00a0\u00bb border_color_right=\u00a0\u00bb#FFFFFF\u00a0\u00bb border_width_right_tablet=\u00a0\u00bb0px\u00a0\u00bb border_width_right_phone=\u00a0\u00bb\u00a0\u00bb border_width_right_last_edited=\u00a0\u00bbon|tablet\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_text _builder_version=\u00a0\u00bb4.18.0&Prime; header_2_text_align=\u00a0\u00bbright\u00a0\u00bb header_2_text_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb header_2_font_size=\u00a0\u00bb36px\u00a0\u00bb text_orientation=\u00a0\u00bbcenter\u00a0\u00bb custom_padding=\u00a0\u00bb||||false|true\u00a0\u00bb link_option_url=\u00a0\u00bb\/wp-content\/uploads\/Customer-Success-Sanjay-Banerjee-v01.mp4&Prime; header_2_text_align_tablet=\u00a0\u00bbcenter\u00a0\u00bb header_2_text_align_phone=\u00a0\u00bb\u00a0\u00bb header_2_text_align_last_edited=\u00a0\u00bbon|tablet\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<p><a class=\"video-popup-button\" href=\"\/wp-content\/uploads\/Customer-Success-Sanjay-Banerjee-v01.mp4\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-16760 size-medium\" src=\"https:\/\/www.arenasolutions.com\/wp-content\/uploads\/Sanjay-Video-Thumbnail-FR.jpg\" alt=\"\" width=\"300\" height=\"169\"\/><\/a><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00a0\u00bb2_3&Prime; _builder_version=\u00a0\u00bb4.16&Prime; custom_padding=\u00a0\u00bb30px||30px|40px|true|false\u00a0\u00bb custom_padding_tablet=\u00a0\u00bb|||0px|false|false\u00a0\u00bb custom_padding_phone=\u00a0\u00bb\u00a0\u00bb custom_padding_last_edited=\u00a0\u00bbon|tablet\u00a0\u00bb custom_css_main_element=\u00a0\u00bbdisplay: grid;||align-content: center;\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_text _builder_version=\u00a0\u00bb4.25.0&Prime; text_text_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb custom_padding=\u00a0\u00bb||||false|false\u00a0\u00bb header_2_text_align_tablet=\u00a0\u00bbcenter\u00a0\u00bb header_2_text_align_phone=\u00a0\u00bb\u00a0\u00bb header_2_text_align_last_edited=\u00a0\u00bbon|tablet\u00a0\u00bb text_orientation_tablet=\u00a0\u00bbcenter\u00a0\u00bb text_orientation_phone=\u00a0\u00bb\u00a0\u00bb text_orientation_last_edited=\u00a0\u00bbon|tablet\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<h2>D\u00c9BAT AUTOUR DE LA QUALIT\u00c9<\/h2>\n<p>Sanjay Banerjee, COO chez Potrero Medical, nous parle des strat\u00e9gies de gestion de la qualit\u00e9 et de la conformit\u00e9.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00a0\u00bb1&Prime; _builder_version=\u00a0\u00bb4.18.0&Prime; custom_margin=\u00a0\u00bb||||false|false\u00a0\u00bb custom_padding=\u00a0\u00bb0px|||||\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_row _builder_version=\u00a0\u00bb4.16&Prime; custom_padding=\u00a0\u00bb0px||18px|||\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_column type=\u00a0\u00bb4_4&Prime; _builder_version=\u00a0\u00bb4.16&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_text admin_label=\u00a0\u00bbFACE AUDITS WITH CONFIDENCE\u00a0\u00bb _builder_version=\u00a0\u00bb4.18.0&Prime; header_2_text_align=\u00a0\u00bbcenter\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<h2 style=\"text-align: center;\" class=\"dark-green\">ABORDER LES AUDITS AVEC S\u00c9R\u00c9NIT\u00c9<\/h2>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00a0\u00bb1_2,1_2&Prime; use_custom_gutter=\u00a0\u00bbon\u00a0\u00bb gutter_width=\u00a0\u00bb4&Prime; make_equal=\u00a0\u00bbon\u00a0\u00bb _builder_version=\u00a0\u00bb4.16&Prime; custom_margin=\u00a0\u00bb||50px||false|false\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_column type=\u00a0\u00bb1_2&Prime; _builder_version=\u00a0\u00bb4.16&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_image src=\u00a0\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Face-Audits.jpg\u00a0\u00bb alt=\u00a0\u00bbMedical Device Audit\u00a0\u00bb title_text=\u00a0\u00bbFace-Audits\u00a0\u00bb _builder_version=\u00a0\u00bb4.18.0&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][\/et_pb_image][\/et_pb_column][et_pb_column type=\u00a0\u00bb1_2&Prime; _builder_version=\u00a0\u00bb4.16&Prime; custom_css_main_element=\u00a0\u00bbdisplay: grid;||align-content: center;\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_text _builder_version=\u00a0\u00bb4.16&Prime; header_4_text_align=\u00a0\u00bbleft\u00a0\u00bb custom_margin=\u00a0\u00bb||0px||false|false\u00a0\u00bb header_4_text_align_tablet=\u00a0\u00bbright\u00a0\u00bb header_4_text_align_phone=\u00a0\u00bb\u00a0\u00bb header_4_text_align_last_edited=\u00a0\u00bbon|tablet\u00a0\u00bb text_orientation_tablet=\u00a0\u00bbright\u00a0\u00bb text_orientation_phone=\u00a0\u00bbleft\u00a0\u00bb text_orientation_last_edited=\u00a0\u00bbon|tablet\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<p><span>La solution Arena QMS permet aux <a href=\"https:\/\/www.arenasolutions.com\/resources\/articles\/medical-device-development\/\">fabricants de dispositifs m\u00e9dicaux<\/a> de classes\u00a0I, II et III de r\u00e9pondre aux exigences des parties\u00a0820 et\u00a011 du titre\u00a021 du CFR de la FDA et de la norme ISO\u00a013485. Nous vous aidons \u00e0 mieux g\u00e9rer vos dossiers de d\u00e9veloppement (DMR), dossiers de conception (DHF), proc\u00e9dures op\u00e9rationnelles normalis\u00e9es (SOP) et dossiers de formation afin de r\u00e9ussir les audits internes ou ceux de la <a href=\"https:\/\/www.arenasolutions.com\/blog\/fdas-adoption-iso-13485-what-medical-device-manufacturers-should-know\/\">FDA<\/a>.<\/span><\/p>\n<p>[\/et_pb_text][et_pb_button button_url=\u00a0\u00bb\/resources\/articles\/fda-audit-tips\/\u00a0\u00bb button_text=\u00a0\u00bb5\u00a0conseils pour r\u00e9ussir les audits FDA ou ISO en toute confiance\u00a0\u00bb module_class=\u00a0\u00bblocale-hide-cn\u00a0\u00bb _builder_version=\u00a0\u00bb4.20.0&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00a0\u00bb1&Prime; admin_label=\u00a0\u00bbPurpose-built PLM\u00a0\u00bb module_class=\u00a0\u00bbquote-section\u00a0\u00bb _builder_version=\u00a0\u00bb4.18.0&Prime; background_image=\u00a0\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/dark-purple-background.jpg\u00a0\u00bb custom_padding=\u00a0\u00bb19px||19px||true|\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_row use_custom_gutter=\u00a0\u00bbon\u00a0\u00bb gutter_width=\u00a0\u00bb1&Prime; make_equal=\u00a0\u00bbon\u00a0\u00bb _builder_version=\u00a0\u00bb4.16&Prime; custom_padding=\u00a0\u00bb20px||20px||true|false\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_column type=\u00a0\u00bb4_4&Prime; _builder_version=\u00a0\u00bb4.16&Prime; custom_padding=\u00a0\u00bb30px||30px|40px|true|false\u00a0\u00bb custom_padding_tablet=\u00a0\u00bb|||0px|false|false\u00a0\u00bb custom_padding_phone=\u00a0\u00bb\u00a0\u00bb custom_padding_last_edited=\u00a0\u00bbon|tablet\u00a0\u00bb custom_css_main_element=\u00a0\u00bbdisplay: grid;||align-content: center;\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_text _builder_version=\u00a0\u00bb4.16&Prime; text_text_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb text_orientation=\u00a0\u00bbcenter\u00a0\u00bb max_width=\u00a0\u00bb985px\u00a0\u00bb module_alignment=\u00a0\u00bbcenter\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<p><span>\u00ab\u00a0Bien que l&rsquo;\u00e9quipe d&rsquo;Arena n&rsquo;ait pas particip\u00e9 \u00e0 l&rsquo;inspection de la FDA, leur solution nous a permis de trouver et d&rsquo;extraire rapidement les informations demand\u00e9es avant l&rsquo;inspection. Merci d&rsquo;avoir cr\u00e9\u00e9 une solution qui r\u00e9pond \u00e0 tous nos besoins et tient toutes ses promesses\u00a0!\u00a0\u00bb<\/span><\/p>\n<p>[\/et_pb_text][et_pb_text _builder_version=\u00a0\u00bb4.18.0&Prime; text_text_color=\u00a0\u00bb#afb1ff\u00a0\u00bb text_orientation=\u00a0\u00bbcenter\u00a0\u00bb custom_margin=\u00a0\u00bb24px||||false|false\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<p><span style=\"color: #ffffff;\"><strong style=\"letter-spacing: 0 !important;\">Michelle J. Potvin&nbsp;&nbsp;<\/strong>ASQ CQA, Director, Quality Assurance &amp; Regulatory Affairs, Swan Valley Medical<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00a0\u00bb1&Prime; module_id=\u00a0\u00bbcustomer-logo-slider\u00a0\u00bb _builder_version=\u00a0\u00bb4.24.2&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_row _builder_version=\u00a0\u00bb4.16&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_column type=\u00a0\u00bb4_4&Prime; _builder_version=\u00a0\u00bb4.16&Prime; global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][et_pb_text _builder_version=\u00a0\u00bb4.18.0&Prime; header_2_text_align=\u00a0\u00bbcenter\u00a0\u00bb text_orientation=\u00a0\u00bbcenter\u00a0\u00bb custom_margin=\u00a0\u00bb||10px||false|false\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<h2 style=\"text-align: center;\" class=\"dark-green\">VENEZ REJOINDRE CES CLIENTS INNOVANTS<\/h2>\n<p>[\/et_pb_text][mt-divi-logo-slider images=\u00a0\u00bb10033,10031,10032,10383,10029,10028,10021,10025,10023,10020,10026,13718,32928,67326&Prime; 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header_2_text_align=\u00a0\u00bbright\u00a0\u00bb header_2_text_color=\u00a0\u00bb#FFFFFF\u00a0\u00bb header_2_font_size=\u00a0\u00bb36px\u00a0\u00bb custom_padding=\u00a0\u00bb||||false|true\u00a0\u00bb header_2_text_align_tablet=\u00a0\u00bbcenter\u00a0\u00bb header_2_text_align_phone=\u00a0\u00bbcenter\u00a0\u00bb header_2_text_align_last_edited=\u00a0\u00bbon|tablet\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb]<\/p>\n<h2>VOIR Arena<br \/> <span style=\"font-family: 'acier-bat-outline';\">EN ACTION<\/span><\/h2>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00a0\u00bb1_2&Prime; _builder_version=\u00a0\u00bb4.16&Prime; custom_padding=\u00a0\u00bb25px|||40px|false|false\u00a0\u00bb custom_padding_tablet=\u00a0\u00bb10px|||0px|false|false\u00a0\u00bb custom_padding_phone=\u00a0\u00bb\u00a0\u00bb custom_padding_last_edited=\u00a0\u00bbon|tablet\u00a0\u00bb custom_css_main_element=\u00a0\u00bbdisplay: grid;||align-content: center;\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb custom_css_main_element_last_edited=\u00a0\u00bbon|tablet\u00a0\u00bb custom_css_main_element_tablet=\u00a0\u00bbpadding-top: 25px !important;\u00a0\u00bb custom_css_main_element_phone=\u00a0\u00bbpadding-top: 25px !important;\u00a0\u00bb][et_pb_button button_url=\u00a0\u00bbhttps:\/\/www.arenasolutions.com\/fr\/qms-demo\/\u00a0\u00bb button_text=\u00a0\u00bbD\u00c9MO\u00a0\u00bb button_alignment=\u00a0\u00bbleft\u00a0\u00bb button_alignment_tablet=\u00a0\u00bbcenter\u00a0\u00bb button_alignment_phone=\u00a0\u00bb\u00a0\u00bb button_alignment_last_edited=\u00a0\u00bbon|phone\u00a0\u00bb _builder_version=\u00a0\u00bb4.16&Prime; custom_margin=\u00a0\u00bb||||false|false\u00a0\u00bb custom_margin_tablet=\u00a0\u00bb\u00a0\u00bb custom_margin_phone=\u00a0\u00bb25px||||false|false\u00a0\u00bb custom_margin_last_edited=\u00a0\u00bbon|phone\u00a0\u00bb global_colors_info=\u00a0\u00bb{}\u00a0\u00bb][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Conformit\u00e9 r\u00e9glementaire des dispositifs m\u00e9dicaux Simplifier la conformit\u00e9 FDA, MDR et ISO ACC\u00c9L\u00c9RER LA PR\u00c9PARATION AUX R\u00c9GLEMENTATIONS ET AUX EXIGENCES Pour garantir la s\u00e9curit\u00e9 des patients, les&#8230;<\/p>\n","protected":false},"author":55,"featured_media":36068,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"divi.php","meta":{"_acf_changed":false,"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"class_list":["post-36066","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Logiciel de gestion de la conformit\u00e9 r\u00e9glementaire des dispositifs m\u00e9dicaux | Arena<\/title>\n<meta name=\"description\" content=\"Le logiciel Arena QMS vous permet de vous conformer aux r\u00e9glementations FDA et ISO. Nous simplifions la conformit\u00e9 \u00e0 la partie\u00a0820 du titre\u00a021 du CFR de la FDA et \u00e0 la norme ISO\u00a013485. Arena g\u00e8re de mani\u00e8re centralis\u00e9e les proc\u00e9dures op\u00e9rationnelles normalis\u00e9es (SOP), les dossiers de conception (DHF), les dossiers de d\u00e9veloppement (DMR), les dossiers de formation, et bien plus encore.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.arenasolutions.com\/fr\/solutions\/compliance-management\/medical-devices\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Conformit\u00e9 des dispositifs m\u00e9dicaux\" \/>\n<meta property=\"og:description\" content=\"Le logiciel Arena QMS vous permet de vous conformer aux r\u00e9glementations FDA et ISO. Nous simplifions la conformit\u00e9 \u00e0 la partie\u00a0820 du titre\u00a021 du CFR de la FDA et \u00e0 la norme ISO\u00a013485. 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