{"id":3008,"date":"2025-12-15T22:09:03","date_gmt":"2025-12-15T22:09:03","guid":{"rendered":"https:\/\/altrion-group.com\/?page_id=3008"},"modified":"2025-12-21T15:23:52","modified_gmt":"2025-12-21T15:23:52","slug":"marcatura-ce-dispositivi-medici","status":"publish","type":"page","link":"https:\/\/altrion-group.com\/it\/marcatura-ce-dispositivi-medici\/","title":{"rendered":"MARCATURA CE"},"content":{"rendered":"<div id='av-layout-grid-1'  class='av-layout-grid-container av-7nloit-088d9e4d481f209b19bd665b92c5c355 entry-content-wrapper main_color av-flex-cells  avia-builder-el-0  el_before_av_section  avia-builder-el-first  av-cell-min-height av-cell-min-height-50  container_wrap fullsize'   data-av_minimum_height_pc='50'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-7iksy5-371b47900e1ae48cdf95b782238e00ce\">\n.flex_cell.av-7iksy5-371b47900e1ae48cdf95b782238e00ce{\nvertical-align:middle;\nbackground:url(https:\/\/altrion-group.com\/wp-content\/uploads\/2023\/01\/marcatura_ce_1030x687.webp) 50% 50% no-repeat scroll #7faccd;\n}\n.responsive #top #wrap_all .flex_cell.av-7iksy5-371b47900e1ae48cdf95b782238e00ce{\npadding:0px 0px 0px 0px !important;\n}\n<\/style>\n<div class='flex_cell av-7iksy5-371b47900e1ae48cdf95b782238e00ce av-gridrow-cell av_one_half no_margin  avia-builder-el-1  el_before_av_cell_one_half  avia-builder-el-first  av-zero-padding avia-full-stretch' ><div class='flex_cell_inner'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lamlndza-867e3767e038d8ce182bfd3131e03a8b\">\n#top .hr.hr-invisible.av-lamlndza-867e3767e038d8ce182bfd3131e03a8b{\nheight:200px;\n}\n<\/style>\n<div  class='hr av-lamlndza-867e3767e038d8ce182bfd3131e03a8b hr-invisible  avia-builder-el-2  avia-builder-el-no-sibling '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n<\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-7eaf2t-13587f053fed9a03a610ec487eca6f29\">\n.flex_cell.av-7eaf2t-13587f053fed9a03a610ec487eca6f29{\nvertical-align:middle;\nbackground-color:#7faccd;\n}\n.responsive #top #wrap_all .flex_cell.av-7eaf2t-13587f053fed9a03a610ec487eca6f29{\npadding:50px 50px 50px 50px !important;\n}\n<\/style>\n<div class='flex_cell av-7eaf2t-13587f053fed9a03a610ec487eca6f29 av-gridrow-cell av_one_half no_margin  avia-builder-el-3  el_after_av_cell_one_half  avia-builder-el-last ' ><div class='flex_cell_inner'><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lamls2p5-def45437252b85f3f33a2c7316ed876d\">\n#top .av-special-heading.av-lamls2p5-def45437252b85f3f33a2c7316ed876d{\npadding-bottom:10px;\ncolor:#ffffff;\nfont-size:34px;\n}\nbody .av-special-heading.av-lamls2p5-def45437252b85f3f33a2c7316ed876d .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-lamls2p5-def45437252b85f3f33a2c7316ed876d .av-special-heading-tag{\nfont-size:34px;\n}\n.av-special-heading.av-lamls2p5-def45437252b85f3f33a2c7316ed876d .special-heading-inner-border{\nborder-color:#ffffff;\n}\n.av-special-heading.av-lamls2p5-def45437252b85f3f33a2c7316ed876d .av-subheading{\nfont-size:15px;\n}\n\n@media only screen and (min-width: 480px) and (max-width: 767px){ \n#top #wrap_all .av-special-heading.av-lamls2p5-def45437252b85f3f33a2c7316ed876d .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n\n@media only screen and (max-width: 479px){ \n#top #wrap_all .av-special-heading.av-lamls2p5-def45437252b85f3f33a2c7316ed876d .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div  class='av-special-heading av-lamls2p5-def45437252b85f3f33a2c7316ed876d av-special-heading-h1 custom-color-heading blockquote modern-quote  avia-builder-el-4  el_before_av_hr  avia-builder-el-first  av-thin-font av-inherit-size'><h1 class='av-special-heading-tag'  itemprop=\"headline\"  ><strong>Marcatura CE<br \/>\ndei dispositivi medici e IVD<\/strong><\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lammyevo-b6b012543a8cd77fa59d26f507e6989a\">\n#top .hr.av-lammyevo-b6b012543a8cd77fa59d26f507e6989a{\nmargin-top:10px;\nmargin-bottom:10px;\n}\n.hr.av-lammyevo-b6b012543a8cd77fa59d26f507e6989a .hr-inner{\nwidth:50px;\nborder-color:#ffffff;\n}\n<\/style>\n<div  class='hr av-lammyevo-b6b012543a8cd77fa59d26f507e6989a hr-custom  avia-builder-el-5  el_after_av_heading  el_before_av_textblock  hr-left hr-icon-no'><span class='hr-inner inner-border-av-border-fat'><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-72sk5p-7799907f0db07ff7d037b986950eade5\">\n#top .av_textblock_section.av-72sk5p-7799907f0db07ff7d037b986950eade5 .avia_textblock{\ncolor:#ffffff;\n}\n<\/style>\n<section  class='av_textblock_section av-72sk5p-7799907f0db07ff7d037b986950eade5'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><p class=\"text-align-center m-size-24 size-30\"><span class=\"m-font-size-24 font-size-30\">Certificazione per l\u2019immissione in commercio<\/span><\/p>\n<p class=\"text-align-center m-size-24 size-30\"><span class=\"m-font-size-24 font-size-30\">di dispositivi medici e IVD in Unione Europea<\/span><\/p>\n<\/div><\/section><\/p>\n<\/div><\/div><\/div><div id='av_section_1'  class='avia-section av-uw1x1-7657275774aaf665c456ddf7d4e909d0 main_color avia-section-default avia-no-border-styling  avia-builder-el-7  el_after_av_layout_row  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-3008'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-syo8d-1f42d04d2346838f771ac9c9ace80e59\">\n.flex_column.av-syo8d-1f42d04d2346838f771ac9c9ace80e59{\n-webkit-border-radius:0px 0px 0px 0px;\n-moz-border-radius:0px 0px 0px 0px;\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class='flex_column av-syo8d-1f42d04d2346838f771ac9c9ace80e59 av_four_fifth  avia-builder-el-8  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding '     ><section  class='av_textblock_section av-a7e1p-6bdefd87f611a2ad6687b37efec4172a'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Per immettere un dispositivo medico sul mercato dell\u2019Unione Europea, i fabbricanti devono conformarsi al\u00a0Regolamento (UE) 2017\/745 (MDR)\u00a0o al\u00a0Regolamento (UE) 2017\/746 (IVDR).<br \/>\nALTRION offre un supporto completo per la\u00a0marcatura CE, dalla preparazione della\u00a0Documentazione Tecnica\u00a0al coordinamento con l\u2019Organismo Notificato\u00a0e alla gestione delle attivit\u00e0 di\u00a0Sorveglianza Post-Market (PMS).<\/p>\n<p><strong>I Nostri Servizi<\/strong><\/p>\n<ul>\n<li>Determinazione della classe del dispositivo (Classe I, Is, Im, IIa, IIb, III)<\/li>\n<li>Preparazione e strutturazione della Documentazione Tecnica (Allegati II e III)<\/li>\n<li>Redazione del Clinical Evaluation Plan (CEP) e del Clinical Evaluation Report (CER) in conformit\u00e0 alle linee guida MDCG<\/li>\n<li>Fascicolo di Gestione del Rischio conforme alla ISO 14971:2019<\/li>\n<li>Ingegneria dell\u2019usabilit\u00e0 (IEC 62366-1) e documentazione del ciclo di vita software (IEC 62304)<\/li>\n<li>Coordinamento con gli Organismi Notificati per le procedure di valutazione della conformit\u00e0 (Allegati IX, X, XI)<\/li>\n<li>Preparazione della Dichiarazione di Conformit\u00e0 UE e della nomina del Rappresentante Autorizzato (EU-REP)<\/li>\n<li>Attivit\u00e0 post-commercializzazione: PMS Plan, PSUR, PMCF e vigilanza<\/li>\n<\/ul>\n<\/div><\/section><\/div>\n<\/p>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lavkffm6-89a19ddf9e9265d6c9bb53d8c559b991\">\n.avia-section.av-lavkffm6-89a19ddf9e9265d6c9bb53d8c559b991{\nbackground-color:#22689e;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_2'  class='avia-section av-lavkffm6-89a19ddf9e9265d6c9bb53d8c559b991 main_color avia-section-default avia-no-border-styling  avia-builder-el-10  el_after_av_section  el_before_av_section  avia-bg-style-scroll av-minimum-height av-minimum-height-20  container_wrap fullsize'   data-av_minimum_height_pc='20'><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-3008'><div class='entry-content-wrapper clearfix'>\n<div class='flex_column av-5ocupa-adf4f9344bafb192a2e6bd8a6777a31c av_one_third  avia-builder-el-11  el_before_av_one_third  avia-builder-el-first  first flex_column_div '     ><\/div><div class='flex_column av-4h150e-095bae0466831e0353062471677caf9b av_one_third  avia-builder-el-12  el_after_av_one_third  el_before_av_one_third  flex_column_div '     ><div  class='avia-button-wrap avia-button-center  avia-builder-el-13  avia-builder-el-no-sibling '>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lavki7rj-12bed064bd5d1ff36e124564a6fea451\">\n#top #wrap_all .avia-button.av-lavki7rj-12bed064bd5d1ff36e124564a6fea451:hover{\ncolor:white;\n-webkit-transition:all 0.4s ease-in-out;\n-moz-transition:all 0.4s ease-in-out;\n-ms-transition:all 0.4s ease-in-out;\n-o-transition:all 0.4s ease-in-out;\ntransition:all 0.4s ease-in-out;\n}\n<\/style>\n<a href='#modulo-contatto' class='av-icon-on-hover avia-color-theme-color avia-font-color-theme-color avia-button avia-button-fullwidth av-lavki7rj-12bed064bd5d1ff36e124564a6fea451 avia-icon_select-yes-right-icon avia-color-theme-color'  ><span class='avia_iconbox_title' >Contattaci<\/span><span class='avia_button_icon avia_button_icon_right' aria-hidden='true' data-av_icon='\ue805' data-av_iconfont='entypo-fontello'><\/span><div class='av-button-description av-button-description-below'><p>Prenota il servizio<\/p>\n<\/div><span class='avia_button_background avia-button avia-button-fullwidth avia-color-theme-color-highlight'><\/span><\/a><\/div><\/div><div class='flex_column av-2sjhy6-df14176a0df0a382aae77749df66c5ae av_one_third  avia-builder-el-14  el_after_av_one_third  avia-builder-el-last  flex_column_div '     ><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lavk1b0k-50841b155ac05d20232abba4632fcbba\">\n.avia-section.av-lavk1b0k-50841b155ac05d20232abba4632fcbba{\nbackground-color:#e6e7e6;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_3'  class='avia-section av-lavk1b0k-50841b155ac05d20232abba4632fcbba main_color avia-section-default avia-no-border-styling  avia-builder-el-15  el_after_av_section  el_before_av_layout_row  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-3008'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2apcny-03ae0a29978934791ae118441d50876c\">\n.flex_column.av-2apcny-03ae0a29978934791ae118441d50876c{\n-webkit-border-radius:0px 0px 0px 0px;\n-moz-border-radius:0px 0px 0px 0px;\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class='flex_column av-2apcny-03ae0a29978934791ae118441d50876c av_four_fifth  avia-builder-el-16  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding '     ><section  class='av_textblock_section av-lavk2t0l-856a369e2f0f62a8578d59a9bc3052af'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><div id=\"1246208796\" class=\"u_1246208796 dmNewParagraph\">\n<div>\n<p><strong>Perch\u00e9 Scegliere ALTRION<\/strong><\/p>\n<ul>\n<li>Oltre 15 anni di esperienza nella transizione al MDR e nelle valutazioni di conformit\u00e0 europee<\/li>\n<li>Team multilingue per la preparazione della documentazione in inglese, francese e italiano<\/li>\n<li>Approfondita esperienza con dispositivi di Classe I\u2013III, IVD e software (SaMD)<\/li>\n<li>Coordinamento fluido tra fabbricante, rappresentante autorizzato (EU-REP) e organismo notificato<\/li>\n<\/ul>\n<p><strong>Risultati forniti<\/strong><\/p>\n<ul>\n<li>Documentazione Tecnica CE\u00a0completa e conforme a MDR\/IVDR<\/li>\n<li>Dichiarazione di Conformit\u00e0 UE<\/li>\n<li>Supporto durante la revisione e l\u2019audit da parte dell\u2019Organismo Notificato<\/li>\n<li>Documentazione di strategia PMS e vigilanza<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div><\/section><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av-layout-grid-2'  class='av-layout-grid-container av-2m8rml-cf1550da75c0a23f15e912f47bff0540 entry-content-wrapper main_color av-flex-cells  avia-builder-el-18  el_after_av_section  avia-builder-el-last  av-cell-min-height av-cell-min-height-25 grid-row-not-first  container_wrap fullsize'   data-av_minimum_height_pc='25'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2c9gfx-e7c714a2c4eecf09731b0ce122b582ff\">\n.flex_cell.av-2c9gfx-e7c714a2c4eecf09731b0ce122b582ff{\nvertical-align:middle;\nbackground-color:#22689e;\n}\n.responsive #top #wrap_all .flex_cell.av-2c9gfx-e7c714a2c4eecf09731b0ce122b582ff{\npadding:50px 50px 50px 50px !important;\n}\n<\/style>\n<div class='flex_cell av-2c9gfx-e7c714a2c4eecf09731b0ce122b582ff av-gridrow-cell av_one_half no_margin  avia-builder-el-19  el_before_av_cell_one_half  avia-builder-el-first  avia-full-stretch' ><div class='flex_cell_inner'><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kguz1-8e92585534b8b6f2169272c9f87ddc3d\">\n#top .av-special-heading.av-kguz1-8e92585534b8b6f2169272c9f87ddc3d{\npadding-bottom:10px;\ncolor:#ffffff;\nfont-size:34px;\n}\nbody .av-special-heading.av-kguz1-8e92585534b8b6f2169272c9f87ddc3d .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-kguz1-8e92585534b8b6f2169272c9f87ddc3d .av-special-heading-tag{\nfont-size:34px;\n}\n.av-special-heading.av-kguz1-8e92585534b8b6f2169272c9f87ddc3d .special-heading-inner-border{\nborder-color:#ffffff;\n}\n.av-special-heading.av-kguz1-8e92585534b8b6f2169272c9f87ddc3d .av-subheading{\nfont-size:15px;\n}\n\n@media only screen and (min-width: 480px) and (max-width: 767px){ \n#top #wrap_all .av-special-heading.av-kguz1-8e92585534b8b6f2169272c9f87ddc3d .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n\n@media only screen and (max-width: 479px){ \n#top #wrap_all .av-special-heading.av-kguz1-8e92585534b8b6f2169272c9f87ddc3d .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div  class='av-special-heading av-kguz1-8e92585534b8b6f2169272c9f87ddc3d av-special-heading-h2 custom-color-heading blockquote modern-quote modern-centered  avia-builder-el-20  el_before_av_hr  avia-builder-el-first  av-thin-font av-inherit-size'><h2 class='av-special-heading-tag'  itemprop=\"headline\"  ><strong>Hai prodotti a cui serve Marcatura CE?<br \/>\nSiamo qui per aiutarti!<\/strong><\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1k8np-a31b6b6b6f0cf69477c7c37e741a2466\">\n#top .hr.av-1k8np-a31b6b6b6f0cf69477c7c37e741a2466{\nmargin-top:10px;\nmargin-bottom:10px;\n}\n.hr.av-1k8np-a31b6b6b6f0cf69477c7c37e741a2466 .hr-inner{\nwidth:50px;\nborder-color:#ffffff;\n}\n<\/style>\n<div  class='hr av-1k8np-a31b6b6b6f0cf69477c7c37e741a2466 hr-custom  avia-builder-el-21  el_after_av_heading  el_before_av_textblock  hr-center hr-icon-no'><span class='hr-inner inner-border-av-border-fat'><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-aasqd-2f8a1807401651b6db6544716e41dc17\">\n#top .av_textblock_section.av-aasqd-2f8a1807401651b6db6544716e41dc17 .avia_textblock{\ncolor:#ffffff;\n}\n<\/style>\n<section  class='av_textblock_section av-aasqd-2f8a1807401651b6db6544716e41dc17'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><p style=\"text-align: center;\">Compila il form con la tua richiesta.<\/p>\n<p style=\"text-align: center;\">Ti contatteremo al pi\u00f9 presto.<\/p>\n<\/div><\/section><\/p>\n<\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2aze9h-e7d67b752f4c05a190c3bec726a2b11c\">\n.flex_cell.av-2aze9h-e7d67b752f4c05a190c3bec726a2b11c{\nvertical-align:middle;\nbackground:url(https:\/\/altrion-group.com\/wp-content\/uploads\/2023\/01\/corporate-buildings-m-1030x687-_1_.webp) 0% 0% no-repeat scroll #22689e;\n}\n.responsive #top #wrap_all .flex_cell.av-2aze9h-e7d67b752f4c05a190c3bec726a2b11c{\npadding:30px 30px 30px 30px !important;\n}\n<\/style>\n<div class='flex_cell av-2aze9h-e7d67b752f4c05a190c3bec726a2b11c av-gridrow-cell av_one_half no_margin  avia-builder-el-23  el_after_av_cell_one_half  avia-builder-el-last  avia-full-stretch' ><div class='flex_cell_inner'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lampn59y-16cdac81044de464c165dfce7cd51d9e\">\n.flex_column.av-lampn59y-16cdac81044de464c165dfce7cd51d9e{\npadding:20px 20px 20px 20px;\nbackground-color:#bfd6e6;\n}\n<\/style>\n<div class='flex_column av-lampn59y-16cdac81044de464c165dfce7cd51d9e av_four_fifth  avia-builder-el-24  avia-builder-el-no-sibling  first flex_column_div '     id=\"modulo-contatto\"  ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lamq769l-6198ca162e9bf78457dec726ab2c95de\">\n#top .av_textblock_section.av-lamq769l-6198ca162e9bf78457dec726ab2c95de .avia_textblock{\ncolor:#ffffff;\n}\n<\/style>\n<section  class='av_textblock_section av-lamq769l-6198ca162e9bf78457dec726ab2c95de'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><h3 style=\"text-align: center;\"><strong>Form di contatto<\/strong><\/h3>\n<\/div><\/section><br \/>\n<form action=\"https:\/\/altrion-group.com\/it\/marcatura-ce-dispositivi-medici\/\" method=\"post\"  class=\"avia_ajax_form av-form-labels-hidden   avia-builder-el-26  el_after_av_textblock  avia-builder-el-last   \" data-avia-form-id=\"1\" data-avia-redirect='https:\/\/altrion-group.com\/it\/messaggio-inviato\/' ><fieldset><p class='  first_form  form_element form_fullwidth' id='element_avia_1_1'><label for=\"avia_1_1\">Nome e Cognome <abbr class=\"required\" title=\"richiesto\">*<\/abbr><\/label> <input name=\"avia_1_1\" class=\"text_input is_empty\" type=\"text\" id=\"avia_1_1\" value=\"\"  placeholder='Nome e 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