{"id":19343,"date":"2022-10-31T17:12:19","date_gmt":"2022-10-31T16:12:19","guid":{"rendered":"https:\/\/qualificagroup.it\/site\/?p=19343"},"modified":"2022-10-31T17:40:52","modified_gmt":"2022-10-31T16:40:52","slug":"certificazione-iso-13485","status":"publish","type":"post","link":"https:\/\/qualificagroup.it\/consulenza\/certificazione-iso-13485\/","title":{"rendered":"ISO 13485"},"content":{"rendered":"<p><section id=\"bt_bb_section6a31fea93ad3b\" class=\"bt_bb_section bt_bb_layout_wide bt_bb_vertical_align_top bt_bb_top_spacing_none bt_bb_bottom_spacing_none\"  data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><div class=\"bt_bb_port\"><div class=\"bt_bb_cell\"><div class=\"bt_bb_cell_inner\"><div class=\"bt_bb_row \"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><div  class=\"bt_bb_column col-xl-6 col-xs-12 col-sm-6 col-md-6 col-lg-6 bt_bb_align_left bt_bb_vertical_align_middle bt_bb_padding_normal\"  data-width=\"6\" data-bt-override-class=\"{&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_left&quot;,&quot;def&quot;:&quot;left&quot;,&quot;xl&quot;:&quot;left&quot;},&quot;bt_bb_padding_&quot;:{&quot;current_class&quot;:&quot;bt_bb_padding_normal&quot;,&quot;def&quot;:&quot;normal&quot;,&quot;xl&quot;:&quot;normal&quot;}}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_slider bt_bb_height_auto bt_bb_animation_fade animate bt_bb_arrows_size_normal\"><div class=\"slick-slider fade\"  data-slick='{ \"lazyLoad\": \"progressive\", \"cssEase\": \"ease-out\", \"speed\": \"300\", \"fade\": true, \"adaptiveHeight\": true, \"prevArrow\": \"\", \"nextArrow\": \"\", \"autoplay\": true, \"autoplaySpeed\": 1500}' ><div class=\"bt_bb_slider_item\" data-src-full=\"https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2022\/10\/Qualifica__ISO-13485-.jpg\"><img decoding=\"async\" data-src=\"https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2022\/10\/Qualifica__ISO-13485-.jpg\" alt=\"Certificazione ISO 13485 dispositivi medici - - -\"  title=\"Certificazione ISO 13485 dispositivi medici - - -\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" class=\"lazyload\" style=\"--smush-placeholder-width: 2500px; --smush-placeholder-aspect-ratio: 2500\/1668;\"><\/div><div class=\"bt_bb_slider_item\" data-src-full=\"https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2022\/10\/Qualifica__ISO-17025-.jpg\"><img decoding=\"async\" data-src=\"https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2022\/10\/Qualifica__ISO-17025-.jpg\" alt=\"certificazione ISO 17025\"  title=\"certificazione ISO 17025\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" class=\"lazyload\" style=\"--smush-placeholder-width: 2500px; --smush-placeholder-aspect-ratio: 2500\/1667;\"><\/div><\/div><\/div><\/div><\/div><div  class=\"bt_bb_column col-xl-6 col-xs-12 col-sm-6 col-md-6 col-lg-6 bt_bb_align_left bt_bb_vertical_align_middle bt_bb_padding_normal\"  data-width=\"6\" data-bt-override-class=\"{&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_left&quot;,&quot;def&quot;:&quot;left&quot;,&quot;xl&quot;:&quot;left&quot;},&quot;bt_bb_padding_&quot;:{&quot;current_class&quot;:&quot;bt_bb_padding_normal&quot;,&quot;def&quot;:&quot;normal&quot;,&quot;xl&quot;:&quot;normal&quot;}}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_raw_content\"><blockquote><span style=\"font-size: 1em;\"><strong><span style=\"color: #ef7d00;\">ISO 13485<\/span><\/strong> -   Dispositivi Medici.<\/span><\/blockquote>\n<h4 style=\"color: #2a4170;\">La Certificazione per i Dispositivi Medici<\/h4><\/div><div  class=\"bt_bb_text\" ><\/p>\n<p>La norma specifica i requisiti per un Sistema di Gestione per la Qualit\u00e0 che permette ad una organizzazione di dimostrare la sua capacit\u00e0 di fornire\u00a0<strong>Dispositivi Medici<\/strong>\u00a0e relativi servizi che siano conformi ai requisiti dei clienti e ai requisiti regolamentari applicabili a tali dispositivi medici.<\/p>\n<p>\n<\/div><div class=\"bt_bb_separator bt_bb_border_style_none bt_bb_top_spacing_normal bt_bb_bottom_spacing_none\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;,&quot;xl&quot;:&quot;normal&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><\/div><div class=\"bt_bb_button bt_bb_color_scheme_6 bt_bb_icon_position_left bt_bb_style_filled bt_bb_size_small bt_bb_width_inline bt_bb_shape_inherit bt_bb_target_self bt_bb_align_inherit\" style=\"; --primary-color:#ffffff; --secondary-color:#ef7d00;\" data-bt-override-class=\"{&quot;bt_bb_size_&quot;:{&quot;current_class&quot;:&quot;bt_bb_size_small&quot;,&quot;def&quot;:&quot;small&quot;,&quot;xl&quot;:&quot;small&quot;},&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;,&quot;xl&quot;:&quot;inherit&quot;}}\"><a href=\"#form_iso\" target=\"_self\" class=\"bt_bb_link\" title=\"CHIEDI UNA CONSULENZA\"><span class=\"bt_bb_button_text\" >CHIEDI UNA CONSULENZA<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div><!-- cell_inner --><\/div><!-- cell --><\/div><!-- port --><\/section><section id=\"bt_bb_section6a31fea93b4a9\" class=\"bt_bb_section bt_bb_layout_wide bt_bb_vertical_align_top bt_bb_top_spacing_none bt_bb_bottom_spacing_none\"  data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><div class=\"bt_bb_port\"><div class=\"bt_bb_cell\"><div class=\"bt_bb_cell_inner\"><div class=\"bt_bb_row \"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><div  class=\"bt_bb_column col-xl-12 col-xs-12 col-sm-12 col-md-12 col-lg-12 bt_bb_align_left bt_bb_vertical_align_top bt_bb_padding_normal\"  data-width=\"12\" data-bt-override-class=\"{}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_separator bt_bb_border_style_none bt_bb_top_spacing_medium bt_bb_bottom_spacing_none\" style=\"color: orange; border-width: 5px; border-color: transparent; border-style: solid;\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_medium&quot;,&quot;def&quot;:&quot;medium&quot;,&quot;xl&quot;:&quot;medium&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><\/div><header class=\"bt_bb_headline bt_bb_dash_bottom bt_bb_size_inherit bt_bb_align_inherit\" style=\";font-family:&#039;Montserrat&#039;;color:rgb(42,65,112);border-color:rgb(42,65,112);\" data-bt-override-class=\"{&quot;bt_bb_size_&quot;:{&quot;current_class&quot;:&quot;bt_bb_size_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;,&quot;xl&quot;:&quot;inherit&quot;},&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;,&quot;xl&quot;:&quot;inherit&quot;}}\"><h3 style=\"font-family:&#039;Montserrat&#039;\" class=\"bt_bb_headline_tag\"><span class=\"bt_bb_headline_content\"><span>A chi \u00e8 rivolta<\/span><\/span><\/h3><\/header><div class=\"bt_bb_separator bt_bb_border_style_none bt_bb_top_spacing_normal bt_bb_bottom_spacing_none\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;,&quot;xl&quot;:&quot;normal&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><\/div><div  class=\"bt_bb_text\" style=\"text-align: justify;\"><\/p>\n<p>L\u2019\u00a0<strong>ISO 13485:2016<\/strong>\u00a0\u00e8 uno standard che pu\u00f2 essere adottato da a tutte le aziende coinvolte nella:<\/p>\n<ul>\n<li><i>Progettazione<\/i><\/li>\n<li><i>Produzione (produttori di dispositivi soggetti a Marcatura CE)<\/i><\/li>\n<li><i>Installazione<\/i><\/li>\n<li><i>Manutenzione<\/i><\/li>\n<li><i>Distribuzione (aziende che commercializzano dispositivi medici)\u00a0<\/i>dei dispositivi medici e relativi servizi<\/li>\n<\/ul>\n<p>La conformit\u00e0 allo standard\u00a0<strong>ISO 13485<\/strong>\u00a0\u00e8 un requisito necessario all\u2019ottenimento della Marcatura CE (per DM di classe III) ai sensi delle direttive europee precedentemente menzionate. Inoltre, avere un sistema di gestione della qualit\u00e0 conforme \u00e8 un requisito necessario per i fabbricanti ma anche per i fornitori critici, mandatari, importatori e distributori in relazione a quanto stabilito dall\u2019MDR (UE) 2017\/745 per i dispositivi medici e dall\u2019IVDR (UE) 2017\/746.<\/p>\n<p>Sebbene la\u00a0<strong>ISO 13485<\/strong>\u00a0non sia uno standard di prodotto, la norma specifica i requisiti tecnici che una buona gestione aziendale deve rispettare per raggiungere un\u2019alta probabilit\u00e0 di ottenere qualit\u00e0 del servizio\/prodotto, per i tipi di prodotto identificati (ad esempio, requisiti per dispositivi medici sterili, o dei dispositivi medici impiantabili).<\/p>\n<p>Con la certificazione\u00a0<strong>ISO 13485<\/strong>\u00a0l\u2019azienda dimostra di essere in grado di immettere sul mercato dispositivi medici (o offrire servizi) sicuri ed efficaci. Si mostra l\u2019impegno che l\u2019azienda ha nel miglioramento continuo dei propri processi e nel raggiungimento di una certa efficacia, mostrando affidabilit\u00e0 sul mercato.<\/p>\n<p>\n<\/div><div class=\"bt_bb_separator bt_bb_border_style_none bt_bb_top_spacing_normal bt_bb_bottom_spacing_none\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;,&quot;xl&quot;:&quot;normal&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><\/div><\/div><\/div><\/div><\/div><\/div><!-- cell_inner --><\/div><!-- cell --><\/div><!-- port --><\/section><section id=\"bt_bb_section6a31fea93b7ec\" class=\"bt_bb_section bt_bb_layout_wide bt_bb_vertical_align_top bt_bb_top_spacing_none bt_bb_bottom_spacing_none bt_bb_hidden_xs bt_bb_hidden_ms\"  data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><div class=\"bt_bb_port\"><div class=\"bt_bb_cell\"><div class=\"bt_bb_cell_inner\"><div class=\"bt_bb_row \"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><div  class=\"bt_bb_column col-xl-12 col-xs-12 col-sm-12 col-md-12 col-lg-12 bt_bb_align_left bt_bb_vertical_align_top bt_bb_padding_normal\"  data-width=\"12\" data-bt-override-class=\"{}\"><div class=\"bt_bb_column_content\"><header class=\"bt_bb_headline bt_bb_dash_bottom bt_bb_size_inherit bt_bb_align_inherit\" style=\";font-family:&#039;Montserrat&#039;;color:rgb(42,65,112);border-color:rgb(42,65,112);\" data-bt-override-class=\"{&quot;bt_bb_size_&quot;:{&quot;current_class&quot;:&quot;bt_bb_size_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;,&quot;xl&quot;:&quot;inherit&quot;},&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;,&quot;xl&quot;:&quot;inherit&quot;}}\"><h3 style=\"font-family:&#039;Montserrat&#039;\" class=\"bt_bb_headline_tag\"><span class=\"bt_bb_headline_content\"><span>La Norma ISO 13485<\/span><\/span><\/h3><\/header><div class=\"bt_bb_separator bt_bb_border_style_none bt_bb_top_spacing_normal bt_bb_bottom_spacing_none\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;,&quot;xl&quot;:&quot;normal&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><\/div><div class=\" bt_bb_row_inner bt_bb_column_inner_gap_normal\"   data-bt-override-class=\"{}\"><div class=\"bt_bb_row_inner_holder\"  ><div  class=\"bt_bb_column_inner col-xl-4 col-xs-12 col-sm-12 col-md-12 col-lg-4 bt_bb_align_left bt_bb_vertical_align_top\"  data-width=\"4\" data-bt-override-class=\"{}\"><div class=\"bt_bb_column_inner_content\"><div class=\"bt_bb_image bt_bb_shape_square bt_bb_target_self bt_bb_align_inherit bt_bb_hover_style_simple bt_bb_content_display_always bt_bb_content_align_middle bt_bb_fill_background_color_full\" data-bt-override-class=\"{&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;,&quot;xl&quot;:&quot;inherit&quot;}}\"><span><img decoding=\"async\" width=\"2500\" height=\"1667\" data-src=\"https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2022\/10\/Qualifica__ISO-17025-.jpg\" class=\"attachment-full size-full lazyload\" alt=\"certificazione ISO 17025\" data-full_image_data-src=\"https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2022\/10\/Qualifica__ISO-17025-.jpg\" title=\"certificazione ISO 17025\" data-srcset=\"https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2022\/10\/Qualifica__ISO-17025-.jpg 2500w, https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2022\/10\/Qualifica__ISO-17025--640x427.jpg 640w, https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2022\/10\/Qualifica__ISO-17025--1280x854.jpg 1280w, https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2022\/10\/Qualifica__ISO-17025--768x512.jpg 768w, https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2022\/10\/Qualifica__ISO-17025--1536x1024.jpg 1536w, https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2022\/10\/Qualifica__ISO-17025--2048x1366.jpg 2048w, https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2022\/10\/Qualifica__ISO-17025--320x213.jpg 320w\" data-sizes=\"(max-width: 2500px) 100vw, 2500px\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" style=\"--smush-placeholder-width: 2500px; --smush-placeholder-aspect-ratio: 2500\/1667;\" \/><\/span><\/div><\/div><\/div><div  class=\"bt_bb_column_inner col-xl-8 col-xs-12 col-sm-12 col-md-12 col-lg-8 bt_bb_align_left bt_bb_vertical_align_top bt_bb_padding_normal\" style=\"text-akign: justify\" data-width=\"8\" data-bt-override-class=\"{&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_left&quot;,&quot;def&quot;:&quot;left&quot;,&quot;xl&quot;:&quot;left&quot;},&quot;bt_bb_padding_&quot;:{&quot;current_class&quot;:&quot;bt_bb_padding_normal&quot;,&quot;def&quot;:&quot;normal&quot;,&quot;xl&quot;:&quot;normal&quot;}}\"><div class=\"bt_bb_column_inner_content\"><div  class=\"bt_bb_text\" style=\"text-align: justify;\"><\/p>\n<p>La\u00a0<strong>UNI CEI EN ISO 13485<\/strong>\u00a0rappresenta lo standard di Sistema di Gestione Qualit\u00e0 specifico per qualsiasi organizzazione del Settore Biomedicale, siano esse fabbricanti o distributori di dispositivi medici, con un occhio di riguardo alla progettazione ed alla commercializzazione dei dispositivi medici, nonch\u00e9 all\u2019erogazione di servizi annessi.<\/p>\n<p>La UNI EN ISO 13485 \u00e8 considerata una norma armonizzata in relazione alle direttive concernenti il settore biomedicale, quali:<\/p>\n<ul>\n<li>Direttiva 2007\/47\/CE che modifica la Direttiva 90\/385\/CEE \u201cDispositivi medici impiantabili\u201d<\/li>\n<li>Direttiva MDD 93\/42\/CEE \u201cDispositivi Medici\u201d<\/li>\n<li>La direttiva 98\/79\/CE \u201cDispositivi medici Diagnostici in vitro (IVD)\u201d<\/li>\n<\/ul>\n<p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"bt_bb_separator bt_bb_border_style_none bt_bb_top_spacing_normal bt_bb_bottom_spacing_none\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;,&quot;xl&quot;:&quot;normal&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><\/div><\/div><\/div><\/div><\/div><div class=\"bt_bb_row \"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><\/div><\/div><\/div><!-- cell_inner --><\/div><!-- cell --><\/div><!-- port --><\/section><section id=\"bt_bb_section6a31fea93be0c\" class=\"bt_bb_section bt_bb_layout_wide bt_bb_vertical_align_middle bt_bb_top_spacing_medium bt_bb_bottom_spacing_medium bt_bb_hidden_sm bt_bb_hidden_md bt_bb_hidden_lg\"  data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_medium&quot;,&quot;def&quot;:&quot;medium&quot;,&quot;xl&quot;:&quot;medium&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_medium&quot;,&quot;def&quot;:&quot;medium&quot;,&quot;xl&quot;:&quot;medium&quot;}}\"><div class=\"bt_bb_background_image_holder_wrapper\"><div class=\"bt_bb_background_image_holder btLazyLoadBackground bt_bb_parallax lazyload\"  data-background_image_src=\"https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2022\/10\/img-portfolio-03-copia.webp\" data-parallax=\"0.7\" data-parallax-offset=\"0\" data-parallax-zoom-start=\"1\" data-parallax-zoom-end=\"1\" data-parallax-blur-start=\"0\" data-parallax-blur-end=\"0\" data-parallax-opacity-start=\"1\" data-parallax-opacity-end=\"1\" style=\" background-image:inherit;\" data-bg-image=\"url(&#039;https:\/\/qualificagroup.it\/consulenza\/wp-content\/plugins\/bold-page-builder\/img\/blank.gif&#039;)\"><\/div><\/div><div class=\"bt_bb_port\"><div class=\"bt_bb_cell\"><div class=\"bt_bb_cell_inner\"><div class=\"bt_bb_row \"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><div  class=\"bt_bb_column col-xl-12 col-xs-12 col-sm-12 col-md-12 col-lg-12 bt_bb_align_left bt_bb_vertical_align_top bt_bb_padding_normal\"  data-width=\"12\" data-bt-override-class=\"{}\"><div class=\"bt_bb_column_content\"><div id=\"torna_su\" class=\"bt_bb_image bt_bb_shape_square bt_bb_target_self bt_bb_align_center bt_bb_hover_style_simple bt_bb_content_display_always bt_bb_content_align_middle bt_bb_animation_zoom_in animate bt_bb_fill_background_color_full\" data-bt-override-class=\"{&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_center&quot;,&quot;def&quot;:&quot;center&quot;,&quot;xl&quot;:&quot;center&quot;}}\"><span><img decoding=\"async\" width=\"600\" height=\"200\" data-src=\"https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2022\/10\/1-Logo-Qualifica.png\" class=\"attachment-full size-full lazyload\" alt=\"Qualifica Group\" data-full_image_data-src=\"https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2022\/10\/1-Logo-Qualifica.png\" title=\"Qualifica Group\" data-srcset=\"https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2022\/10\/1-Logo-Qualifica.png 600w, https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2022\/10\/1-Logo-Qualifica-320x107.png 320w\" data-sizes=\"(max-width: 600px) 100vw, 600px\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" style=\"--smush-placeholder-width: 600px; --smush-placeholder-aspect-ratio: 600\/200;\" \/><\/span><\/div><\/div><\/div><\/div><\/div><\/div><!-- cell_inner --><\/div><!-- cell --><\/div><!-- port --><\/section><section id=\"bt_bb_section6a31fea93c0b5\" class=\"bt_bb_section bt_bb_layout_wide bt_bb_vertical_align_top bt_bb_top_spacing_none bt_bb_bottom_spacing_none bt_bb_hidden_xs bt_bb_hidden_ms\"  data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><div class=\"bt_bb_port\"><div class=\"bt_bb_cell\"><div class=\"bt_bb_cell_inner\"><div class=\"bt_bb_row \"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><div  class=\"bt_bb_column col-xl-12 col-xs-12 col-sm-12 col-md-12 col-lg-12 bt_bb_align_left bt_bb_vertical_align_top bt_bb_padding_normal\"  data-width=\"12\" data-bt-override-class=\"{}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_separator bt_bb_border_style_none bt_bb_top_spacing_normal bt_bb_bottom_spacing_none\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;,&quot;xl&quot;:&quot;normal&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><\/div><header class=\"bt_bb_headline bt_bb_dash_bottom bt_bb_size_inherit bt_bb_align_inherit\" style=\";font-family:&#039;Montserrat&#039;;color:rgb(42,65,112);border-color:rgb(42,65,112);\" data-bt-override-class=\"{&quot;bt_bb_size_&quot;:{&quot;current_class&quot;:&quot;bt_bb_size_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;,&quot;xl&quot;:&quot;inherit&quot;},&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;,&quot;xl&quot;:&quot;inherit&quot;}}\"><h3 style=\"font-family:&#039;Montserrat&#039;\" class=\"bt_bb_headline_tag\"><span class=\"bt_bb_headline_content\"><span>La Proposta<\/span><\/span><\/h3><\/header><div class=\"bt_bb_separator bt_bb_border_style_none bt_bb_top_spacing_normal bt_bb_bottom_spacing_none\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;,&quot;xl&quot;:&quot;normal&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><\/div><div  class=\"bt_bb_text\" style=\"text-align: justify;\"><\/p>\n<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-33c3353 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"33c3353\" data-element_type=\"section\">\n<div class=\"elementor-container elementor-column-gap-no\">\n<div class=\"elementor-row\">\n<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-a919e31\" data-id=\"a919e31\" data-element_type=\"column\">\n<div class=\"elementor-column-wrap elementor-element-populated\">\n<div class=\"elementor-widget-wrap\">\n<div class=\"elementor-element elementor-element-ead3c1b elementor-widget elementor-widget-text-editor\" data-id=\"ead3c1b\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n<div class=\"elementor-widget-container\">\n<div class=\"elementor-text-editor elementor-clearfix\">\n<p>Qualifica Group, operante nel settore biomedico da oltre 10 anni, \u00e8 la scelta migliore per supportarvi durante l\u2019iter di certificazione EN ISO 13485:2016. Da sempre il miglior alleato per la tua azienda, Qualifica Group \u00e8 in grado di valorizzare le attivit\u00e0 e le risorse aziendali, riducendo gli sprechi e incrementando le performances aziendali interne ed esterne, con focus sulla sicurezza dei dispositivi medici dalla fase di progettazione fino alla fabbricazione, mediante:<\/p>\n<ol>\n<li>Check- Up Aziendale con sopralluogo tecnico per verificare le attivit\u00e0, i processi, ruoli e funzioni aziendali<\/li>\n<li>Classificazione del dispositivo medico (allegato, classi di appartenenza, modulo)<\/li>\n<li>Supporto nella scelta dell\u2019Organismo di Certificazione (OdC)<\/li>\n<li>Monitoraggio delle attivit\u00e0 di Design and Development del dispositivo medico<\/li>\n<li>Gestione delle Azioni Correttive e Preventive (CAPA)<\/li>\n<li>Aggiornamento continuo dei requisiti normativi (UE 90\/385\/CEE, UE 93\/42\/CEE, UE 98\/97\/CE)<\/li>\n<li>Monitoraggio dei processi di scelta e controllo fornitori<\/li>\n<li>Gestione e procedure di Rilascio e\/o controllo dei prodotti<\/li>\n<li>Attenzione alla procedura di risk management (secondo la Norma EN 1441 o la EN 14971) durante tutte le fasi di realizzazione del prodotto<\/li>\n<li>Implementazione\/stesura della seguente documentazione:<br \/>\n10.1 \u2013 Fascicolo tecnico<br \/>\n10.2 \u2013 Manuale d\u2019uso e manutenzione<br \/>\n10.3 \u2013 Istruzioni d\u2019uso (IFU) ed etichetta di commercializzazione<br \/>\n10.4 \u2013 Modello di Dichiarazione del Fabbricante<\/li>\n<li>Audit interni atti a verificare la conformit\u00e0 alla norma ISO 13485 ed alla Direttiva 93\/42\/CE<\/li>\n<li>Formazione del personale sulla normativa EN ISO 13485 e Direttiva 93\/42\/CEE \u2013 Principi base<\/li>\n<\/ol>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-482a4e4 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"482a4e4\" data-element_type=\"section\">\n<div class=\"elementor-container elementor-column-gap-default\">\n<div class=\"elementor-row\">\n<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-11d3719\" data-id=\"11d3719\" data-element_type=\"column\">\n<div class=\"elementor-column-wrap elementor-element-populated\">\n<div class=\"elementor-widget-wrap\">\n<div class=\"elementor-element elementor-element-6fc51ba elementor-widget elementor-widget-menu-anchor\" data-id=\"6fc51ba\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\"><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<p>\n<\/div><div class=\"bt_bb_separator bt_bb_border_style_none bt_bb_top_spacing_normal bt_bb_bottom_spacing_none\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;,&quot;xl&quot;:&quot;normal&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><\/div><\/div><\/div><\/div><\/div><div class=\"bt_bb_row \"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><\/div><\/div><\/div><!-- cell_inner --><\/div><!-- cell --><\/div><!-- port --><\/section><section id=\"bt_bb_section6a31fea93c446\" class=\"bt_bb_section bt_bb_layout_wide bt_bb_vertical_align_top bt_bb_top_spacing_none bt_bb_bottom_spacing_none bt_bb_hidden_xs bt_bb_hidden_ms\"  data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><div class=\"bt_bb_port\"><div class=\"bt_bb_cell\"><div class=\"bt_bb_cell_inner\"><div class=\"bt_bb_row \"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><div  class=\"bt_bb_column col-xl-12 col-xs-12 col-sm-12 col-md-12 col-lg-12 bt_bb_align_left bt_bb_vertical_align_top bt_bb_padding_normal\"  data-width=\"12\" data-bt-override-class=\"{}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_separator bt_bb_border_style_none bt_bb_top_spacing_normal bt_bb_bottom_spacing_none\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;,&quot;xl&quot;:&quot;normal&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><\/div><header class=\"bt_bb_headline bt_bb_dash_bottom bt_bb_size_inherit bt_bb_align_inherit\" style=\";font-family:&#039;Montserrat&#039;;color:rgb(42,65,112);border-color:rgb(42,65,112);\" data-bt-override-class=\"{&quot;bt_bb_size_&quot;:{&quot;current_class&quot;:&quot;bt_bb_size_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;,&quot;xl&quot;:&quot;inherit&quot;},&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;,&quot;xl&quot;:&quot;inherit&quot;}}\"><h3 style=\"font-family:&#039;Montserrat&#039;\" class=\"bt_bb_headline_tag\"><span class=\"bt_bb_headline_content\"><span>I Vantaggi<\/span><\/span><\/h3><\/header><div class=\"bt_bb_separator bt_bb_border_style_none bt_bb_top_spacing_normal bt_bb_bottom_spacing_none\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;,&quot;xl&quot;:&quot;normal&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><\/div><div  class=\"bt_bb_text\" style=\"text-align: justify;\"><\/p>\n<p>La certificazione EN ISO 13485 offre i seguenti vantaggi:<\/p>\n<ul>\n<li>Di partecipare a gare pubbliche della pubblica amministrazione per le aziende che commercializzano o distribuiscono dispositivi medici o per aziende che forniscono servizi associati a dispositivi<\/li>\n<li>Di essere il punto di partenza per l\u2019applicazione dei GMP internazionali<\/li>\n<li>Una maggiore credibilit\u00e0 sul mercato conseguente vantaggio competitivo<\/li>\n<li>Di aumentare l\u2019efficacia con l\u2019introduzione di processi strutturati<\/li>\n<\/ul>\n<p>\n<\/div><div class=\"bt_bb_separator bt_bb_border_style_none bt_bb_top_spacing_normal bt_bb_bottom_spacing_none\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;,&quot;xl&quot;:&quot;normal&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><\/div><\/div><\/div><\/div><\/div><\/div><!-- cell_inner --><\/div><!-- cell --><\/div><!-- port --><\/section><section id=\"bt_bb_section6a31fea93c670\" class=\"bt_bb_section bt_bb_layout_wide bt_bb_vertical_align_top bt_bb_top_spacing_none bt_bb_bottom_spacing_none bt_bb_hidden_md bt_bb_hidden_lg\"  data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><div class=\"bt_bb_port\"><div class=\"bt_bb_cell\"><div class=\"bt_bb_cell_inner\"><div class=\"bt_bb_row \"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><div  class=\"bt_bb_column col-xl-12 col-xs-12 col-sm-12 col-md-12 col-lg-12 bt_bb_align_left bt_bb_vertical_align_top bt_bb_padding_normal\"  data-width=\"12\" data-bt-override-class=\"{}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_tabs bt_bb_color_scheme_4 bt_bb_style_outline bt_bb_shape_round\" style=\"text-align: justify; --tabs-primary-color:#ef7d00; --tabs-secondary-color:#ffffff;\" data-bt-override-class=\"{}\"><ul class=\"bt_bb_tabs_header\"><li><span>La Norma ISO 13485<\/span><\/li><li><span>La Proposta<\/span><\/li><li><span>I Vantaggi<\/span><\/li><\/ul><div class=\"bt_bb_tabs_tabs\"><div class=\"bt_bb_tab_item\">\n\t\t\t<div class=\"bt_bb_tab_content\"><div class=\"bt_bb_separator bt_bb_border_style_none bt_bb_top_spacing_medium bt_bb_bottom_spacing_none\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_medium&quot;,&quot;def&quot;:&quot;medium&quot;,&quot;xl&quot;:&quot;medium&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><\/div><header class=\"bt_bb_headline bt_bb_dash_bottom bt_bb_size_inherit bt_bb_align_inherit\" style=\";font-family:&#039;Montserrat&#039;;color:rgb(42,65,112);border-color:rgb(42,65,112);\" data-bt-override-class=\"{&quot;bt_bb_size_&quot;:{&quot;current_class&quot;:&quot;bt_bb_size_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;,&quot;xl&quot;:&quot;inherit&quot;},&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;,&quot;xl&quot;:&quot;inherit&quot;}}\"><h3 style=\"font-family:&#039;Montserrat&#039;\" class=\"bt_bb_headline_tag\"><span class=\"bt_bb_headline_content\"><span>La Norma ISO 13485<\/span><\/span><\/h3><\/header><div class=\"bt_bb_separator bt_bb_border_style_none bt_bb_top_spacing_normal bt_bb_bottom_spacing_none\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;,&quot;xl&quot;:&quot;normal&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><\/div><div  class=\"bt_bb_text\" style=\"text-align: justify;\"><\/p>\n<p>La\u00a0<strong>UNI CEI EN ISO 13485<\/strong>\u00a0rappresenta lo standard di Sistema di Gestione Qualit\u00e0 specifico per qualsiasi organizzazione del Settore Biomedicale, siano esse fabbricanti o distributori di dispositivi medici, con un occhio di riguardo alla progettazione ed alla commercializzazione dei dispositivi medici, nonch\u00e9 all\u2019erogazione di servizi annessi.<\/p>\n<p>La UNI EN ISO 13485 \u00e8 considerata una norma armonizzata in relazione alle direttive concernenti il settore biomedicale, quali:<\/p>\n<ul>\n<li>Direttiva 2007\/47\/CE che modifica la Direttiva 90\/385\/CEE \u201cDispositivi medici impiantabili\u201d<\/li>\n<li>Direttiva MDD 93\/42\/CEE \u201cDispositivi Medici\u201d<\/li>\n<li>La direttiva 98\/79\/CE \u201cDispositivi medici Diagnostici in vitro (IVD)\u201d<\/li>\n<\/ul>\n<p>\n<\/div><\/div>\n\t\t<\/div><div class=\"bt_bb_tab_item\">\n\t\t\t<div class=\"bt_bb_tab_content\"><div class=\"bt_bb_separator bt_bb_border_style_none bt_bb_top_spacing_medium bt_bb_bottom_spacing_none\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_medium&quot;,&quot;def&quot;:&quot;medium&quot;,&quot;xl&quot;:&quot;medium&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><\/div><header class=\"bt_bb_headline bt_bb_dash_bottom bt_bb_size_inherit bt_bb_align_inherit\" style=\";font-family:&#039;Montserrat&#039;;color:rgb(42,65,112);border-color:rgb(42,65,112);\" data-bt-override-class=\"{&quot;bt_bb_size_&quot;:{&quot;current_class&quot;:&quot;bt_bb_size_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;,&quot;xl&quot;:&quot;inherit&quot;},&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;,&quot;xl&quot;:&quot;inherit&quot;}}\"><h3 style=\"font-family:&#039;Montserrat&#039;\" class=\"bt_bb_headline_tag\"><span class=\"bt_bb_headline_content\"><span>La Proposta<\/span><\/span><\/h3><\/header><div class=\"bt_bb_separator bt_bb_border_style_none bt_bb_top_spacing_normal bt_bb_bottom_spacing_none\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;,&quot;xl&quot;:&quot;normal&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><\/div><div  class=\"bt_bb_text\" style=\"text-align: justify;\"><\/p>\n<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-33c3353 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"33c3353\" data-element_type=\"section\">\n<div class=\"elementor-container elementor-column-gap-no\">\n<div class=\"elementor-row\">\n<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-a919e31\" data-id=\"a919e31\" data-element_type=\"column\">\n<div class=\"elementor-column-wrap elementor-element-populated\">\n<div class=\"elementor-widget-wrap\">\n<div class=\"elementor-element elementor-element-ead3c1b elementor-widget elementor-widget-text-editor\" data-id=\"ead3c1b\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n<div class=\"elementor-widget-container\">\n<div class=\"elementor-text-editor elementor-clearfix\">\n<p>Qualifica Group, operante nel settore biomedico da oltre 10 anni, \u00e8 la scelta migliore per supportarvi durante l\u2019iter di certificazione EN ISO 13485:2016. Da sempre il miglior alleato per la tua azienda, Qualifica Group \u00e8 in grado di valorizzare le attivit\u00e0 e le risorse aziendali, riducendo gli sprechi e incrementando le performances aziendali interne ed esterne, con focus sulla sicurezza dei dispositivi medici dalla fase di progettazione fino alla fabbricazione, mediante:<\/p>\n<ol>\n<li>Check- Up Aziendale con sopralluogo tecnico per verificare le attivit\u00e0, i processi, ruoli e funzioni aziendali<\/li>\n<li>Classificazione del dispositivo medico (allegato, classi di appartenenza, modulo)<\/li>\n<li>Supporto nella scelta dell\u2019Organismo di Certificazione (OdC)<\/li>\n<li>Monitoraggio delle attivit\u00e0 di Design and Development del dispositivo medico<\/li>\n<li>Gestione delle Azioni Correttive e Preventive (CAPA)<\/li>\n<li>Aggiornamento continuo dei requisiti normativi (UE 90\/385\/CEE, UE 93\/42\/CEE, UE 98\/97\/CE)<\/li>\n<li>Monitoraggio dei processi di scelta e controllo fornitori<\/li>\n<li>Gestione e procedure di Rilascio e\/o controllo dei prodotti<\/li>\n<li>Attenzione alla procedura di risk management (secondo la Norma EN 1441 o la EN 14971) durante tutte le fasi di realizzazione del prodotto<\/li>\n<li>Implementazione\/stesura della seguente documentazione:<br \/>\n10.1 \u2013 Fascicolo tecnico<br \/>\n10.2 \u2013 Manuale d\u2019uso e manutenzione<br \/>\n10.3 \u2013 Istruzioni d\u2019uso (IFU) ed etichetta di commercializzazione<br \/>\n10.4 \u2013 Modello di Dichiarazione del Fabbricante<\/li>\n<li>Audit interni atti a verificare la conformit\u00e0 alla norma ISO 13485 ed alla Direttiva 93\/42\/CE<\/li>\n<li>Formazione del personale sulla normativa EN ISO 13485 e Direttiva 93\/42\/CEE \u2013 Principi base<\/li>\n<\/ol>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-482a4e4 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"482a4e4\" data-element_type=\"section\">\n<div class=\"elementor-container elementor-column-gap-default\">\n<div class=\"elementor-row\">\n<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-11d3719\" data-id=\"11d3719\" data-element_type=\"column\">\n<div class=\"elementor-column-wrap elementor-element-populated\">\n<div class=\"elementor-widget-wrap\">\n<div class=\"elementor-element elementor-element-6fc51ba elementor-widget elementor-widget-menu-anchor\" data-id=\"6fc51ba\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\"><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<p>\n<\/div><\/div>\n\t\t<\/div><div class=\"bt_bb_tab_item\">\n\t\t\t<div class=\"bt_bb_tab_content\"><div class=\"bt_bb_separator bt_bb_border_style_none bt_bb_top_spacing_medium bt_bb_bottom_spacing_none\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_medium&quot;,&quot;def&quot;:&quot;medium&quot;,&quot;xl&quot;:&quot;medium&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><\/div><header class=\"bt_bb_headline bt_bb_dash_bottom bt_bb_size_inherit bt_bb_align_inherit\" style=\";font-family:&#039;Montserrat&#039;;color:rgb(42,65,112);border-color:rgb(42,65,112);\" data-bt-override-class=\"{&quot;bt_bb_size_&quot;:{&quot;current_class&quot;:&quot;bt_bb_size_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;,&quot;xl&quot;:&quot;inherit&quot;},&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;,&quot;xl&quot;:&quot;inherit&quot;}}\"><h3 style=\"font-family:&#039;Montserrat&#039;\" class=\"bt_bb_headline_tag\"><span class=\"bt_bb_headline_content\"><span>Vantaggi<\/span><\/span><\/h3><\/header><div class=\"bt_bb_separator bt_bb_border_style_none bt_bb_top_spacing_normal bt_bb_bottom_spacing_none\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;,&quot;xl&quot;:&quot;normal&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><\/div><div  class=\"bt_bb_text\" style=\"text-align: justify;\"><\/p>\n<p>La certificazione EN ISO 13485 offre i seguenti vantaggi:<\/p>\n<ul>\n<li>Di partecipare a gare pubbliche della pubblica amministrazione per le aziende che commercializzano o distribuiscono dispositivi medici o per aziende che forniscono servizi associati a dispositivi<\/li>\n<li>Di essere il punto di partenza per l\u2019applicazione dei GMP internazionali<\/li>\n<li>Una maggiore credibilit\u00e0 sul mercato conseguente vantaggio competitivo<\/li>\n<li>Di aumentare l\u2019efficacia con l\u2019introduzione di processi strutturati<\/li>\n<\/ul>\n<p>\n<\/div><\/div>\n\t\t<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><!-- cell_inner --><\/div><!-- cell --><\/div><!-- port --><\/section><section id=\"bt_bb_section6a31fea93ce39\" class=\"bt_bb_section bt_bb_layout_boxed_1200 bt_bb_vertical_align_top bt_bb_top_spacing_small bt_bb_bottom_spacing_none bt_bb_hidden_sm bt_bb_hidden_md bt_bb_hidden_lg\"  data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_small&quot;,&quot;def&quot;:&quot;small&quot;,&quot;xl&quot;:&quot;small&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><div class=\"bt_bb_port\"><div class=\"bt_bb_cell\"><div class=\"bt_bb_cell_inner\"><div class=\"bt_bb_row \"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><div  class=\"bt_bb_column col-xl-12 col-xs-12 col-sm-12 col-md-12 col-lg-12 bt_bb_align_left bt_bb_vertical_align_middle bt_bb_padding_double\"  data-width=\"12\" data-bt-override-class=\"{&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_left&quot;,&quot;def&quot;:&quot;left&quot;,&quot;xl&quot;:&quot;left&quot;},&quot;bt_bb_padding_&quot;:{&quot;current_class&quot;:&quot;bt_bb_padding_double&quot;,&quot;def&quot;:&quot;double&quot;,&quot;xl&quot;:&quot;double&quot;}}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_button bt_bb_color_scheme_6 bt_bb_icon_position_left bt_bb_style_filled bt_bb_size_medium bt_bb_width_inline bt_bb_shape_inherit bt_bb_target_self bt_bb_align_center\" style=\"; --primary-color:#ffffff; --secondary-color:#ef7d00;\" data-bt-override-class=\"{&quot;bt_bb_size_&quot;:{&quot;current_class&quot;:&quot;bt_bb_size_medium&quot;,&quot;def&quot;:&quot;medium&quot;,&quot;xl&quot;:&quot;medium&quot;},&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_center&quot;,&quot;def&quot;:&quot;center&quot;,&quot;xl&quot;:&quot;center&quot;}}\"><a href=\"#torna_su\" target=\"_self\" class=\"bt_bb_link\" title=\"Torna Su\"><span class=\"bt_bb_button_text\" >Torna Su<\/span><span  data-ico-fontawesome=\"&#xf0aa;\" class=\"bt_bb_icon_holder\"><\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div><!-- cell_inner --><\/div><!-- cell --><\/div><!-- port --><\/section><section id=\"form_iso\" class=\"bt_bb_section bt_bb_layout_wide bt_bb_vertical_align_top bt_bb_top_spacing_none bt_bb_bottom_spacing_none\"  data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><div class=\"bt_bb_port\"><div class=\"bt_bb_cell\"><div class=\"bt_bb_cell_inner\"><div class=\"bt_bb_row  bt_bb_column_gap_medium\"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><div  class=\"bt_bb_column col-xl-6 col-xs-12 col-sm-6 col-md-6 col-lg-6 bt_bb_align_left bt_bb_vertical_align_top bt_bb_padding_normal\"  data-width=\"6\" data-bt-override-class=\"{}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_separator bt_bb_border_style_none bt_bb_top_spacing_medium bt_bb_bottom_spacing_none\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_medium&quot;,&quot;def&quot;:&quot;medium&quot;,&quot;xl&quot;:&quot;medium&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><\/div><div class=\"bt_bb_image bt_bb_shape_square bt_bb_target_self bt_bb_align_inherit bt_bb_hover_style_simple bt_bb_content_display_always bt_bb_content_align_middle bt_bb_fill_background_color_full\" data-bt-override-class=\"{&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;,&quot;xl&quot;:&quot;inherit&quot;}}\"><span><img decoding=\"async\" width=\"817\" height=\"798\" data-src=\"https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2019\/04\/img-quote.png\" class=\"attachment-full size-full lazyload\" alt=\"https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2019\/04\/img-quote.png\" data-full_image_data-src=\"https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2019\/04\/img-quote.png\" data-srcset=\"https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2019\/04\/img-quote.png 817w, https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2019\/04\/img-quote-640x625.png 640w, https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2019\/04\/img-quote-768x750.png 768w, https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2019\/04\/img-quote-320x313.png 320w\" data-sizes=\"(max-width: 817px) 100vw, 817px\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" style=\"--smush-placeholder-width: 817px; --smush-placeholder-aspect-ratio: 817\/798;\" \/><\/span><\/div><\/div><\/div><div  class=\"bt_bb_column col-xl-6 col-xs-12 col-sm-6 col-md-6 col-lg-6 bt_bb_align_left bt_bb_vertical_align_top bt_bb_padding_normal\"  data-width=\"6\" data-bt-override-class=\"{}\"><div class=\"bt_bb_column_content\"><div class=\"bt_bb_separator bt_bb_border_style_none bt_bb_top_spacing_medium bt_bb_bottom_spacing_none\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_medium&quot;,&quot;def&quot;:&quot;medium&quot;,&quot;xl&quot;:&quot;medium&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><\/div><header class=\"bt_bb_headline bt_bb_dash_bottom bt_bb_size_inherit bt_bb_align_inherit\" style=\";font-family:&#039;Montserrat&#039;;color:rgb(42,65,112);border-color:rgb(42,65,112);\" data-bt-override-class=\"{&quot;bt_bb_size_&quot;:{&quot;current_class&quot;:&quot;bt_bb_size_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;,&quot;xl&quot;:&quot;inherit&quot;},&quot;bt_bb_align_&quot;:{&quot;current_class&quot;:&quot;bt_bb_align_inherit&quot;,&quot;def&quot;:&quot;inherit&quot;,&quot;xl&quot;:&quot;inherit&quot;}}\"><h3 style=\"font-family:&#039;Montserrat&#039;\" class=\"bt_bb_headline_tag\"><span class=\"bt_bb_headline_content\"><span>Contattaci Subito<\/span><\/span><\/h3><\/header><div class=\"bt_bb_separator bt_bb_border_style_none bt_bb_top_spacing_normal bt_bb_bottom_spacing_none\" data-bt-override-class=\"{&quot;bt_bb_top_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_top_spacing_normal&quot;,&quot;def&quot;:&quot;normal&quot;,&quot;xl&quot;:&quot;normal&quot;},&quot;bt_bb_bottom_spacing_&quot;:{&quot;current_class&quot;:&quot;bt_bb_bottom_spacing_none&quot;,&quot;def&quot;:&quot;none&quot;,&quot;xl&quot;:&quot;none&quot;}}\"><\/div><div class=\"bt_bb_contact_form_7\">\n<div class=\"wpcf7 no-js\" id=\"wpcf7-f17397-o1\" lang=\"it-IT\" dir=\"ltr\" data-wpcf7-id=\"17397\">\n<div class=\"screen-reader-response\"><p role=\"status\" aria-live=\"polite\" aria-atomic=\"true\"><\/p> <ul><\/ul><\/div>\n<form action=\"\/consulenza\/wp-json\/wp\/v2\/posts\/19343#wpcf7-f17397-o1\" method=\"post\" class=\"wpcf7-form init\" aria-label=\"Modulo di contatto\" novalidate=\"novalidate\" data-status=\"init\">\n<fieldset class=\"hidden-fields-container\"><input type=\"hidden\" name=\"_wpcf7\" value=\"17397\" \/><input type=\"hidden\" name=\"_wpcf7_version\" value=\"6.1.6\" \/><input type=\"hidden\" name=\"_wpcf7_locale\" value=\"it_IT\" \/><input type=\"hidden\" name=\"_wpcf7_unit_tag\" value=\"wpcf7-f17397-o1\" \/><input type=\"hidden\" name=\"_wpcf7_container_post\" value=\"0\" \/><input type=\"hidden\" name=\"_wpcf7_posted_data_hash\" value=\"\" \/><input type=\"hidden\" name=\"_wpcf7_recaptcha_response\" value=\"\" \/>\n<\/fieldset>\n<div class=\"bt_bb_cf7_form\">\n\t<div class=\"bt_bb_cf7_row\">\n\t\t<div class=\"bt_bb_cf7_element\">\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"nome-azienda\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Nome Azienda *\" value=\"\" type=\"text\" name=\"nome-azienda\" \/><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"bt_bb_cf7_row\">\n\t\t<div class=\"bt_bb_cf7_element\">\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"referente-azienda\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Referente Azienda *\" value=\"\" type=\"text\" name=\"referente-azienda\" \/><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"bt_bb_cf7_row\">\n\t\t<div class=\"bt_bb_cf7_element\">\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"email\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Email *\" value=\"\" type=\"email\" name=\"email\" \/><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"bt_bb_cf7_row\">\n\t\t<div class=\"bt_bb_cf7_element\">\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"telefono\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-tel wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-tel\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Telefono *\" value=\"\" type=\"tel\" name=\"telefono\" \/><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"bt_bb_cf7_row\">\n\t\t<div class=\"bt_bb_cf7_element\">\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"select-area\"><select class=\"wpcf7-form-control wpcf7-select wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" name=\"select-area\"><option value=\"-- Seleziona un servizio --\">-- Seleziona un servizio --<\/option><option value=\"Certificazioni ISO\">Certificazioni ISO<\/option><option value=\"Sicurezza D.Lgs. 81\/08\">Sicurezza D.Lgs. 81\/08<\/option><option value=\"Transizione 5.0\">Transizione 5.0<\/option><option value=\"Bando ISI INAIL\">Bando ISI INAIL<\/option><option value=\"Industria 4.0\">Industria 4.0<\/option><option value=\"Bonus Investimenti SUD\">Bonus Investimenti SUD<\/option><option value=\"GDPR-Privacy\">GDPR-Privacy<\/option><option value=\"FRC - Fondo Regionale Crescita Campania\">FRC - Fondo Regionale Crescita Campania<\/option><option value=\"Fondi &amp; Agevolazioni\">Fondi &amp; Agevolazioni<\/option><option value=\"Resto al Sud\">Resto al Sud<\/option><option value=\"Resto al Sud 2.0\">Resto al Sud 2.0<\/option><option value=\"Consulenza Ambientale\">Consulenza Ambientale<\/option><option value=\"Procedure di Gara\">Procedure di Gara<\/option><option value=\"Attestazioni SOA\">Attestazioni SOA<\/option><option value=\"HACCP\">HACCP<\/option><option value=\"ZES Unica Mezzogiorno\">ZES Unica Mezzogiorno<\/option><option value=\"Altro\">Altro<\/option><\/select><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"bt_bb_cf7_element\">\n\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"messaggio\"><textarea cols=\"40\" rows=\"4\" maxlength=\"2000\" class=\"wpcf7-form-control wpcf7-textarea wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"A cosa sei interessato? Scrivi un messaggio *\" name=\"messaggio\"><\/textarea><\/span>\n\t\t<\/p>\n\t<\/div>\n<\/div>\n<div class=\"bt_bb_cf7_row\" style=\"margin-top: 10px; text-align: left;\">\n\t<div class=\"bt_bb_cf7_element\">\n\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"menu-provenienza\"><select class=\"wpcf7-form-control wpcf7-select\" aria-invalid=\"false\" name=\"menu-provenienza\"><option value=\"-- Come ci hai conosciuto? --\">-- Come ci hai conosciuto? --<\/option><option value=\"Sito Web\">Sito Web<\/option><option value=\"Social Facebook\">Social Facebook<\/option><option value=\"Social Instagram\">Social Instagram<\/option><option value=\"Ricerca Google\">Ricerca Google<\/option><option value=\"Annuncio Google\">Annuncio Google<\/option><option value=\"Passaparola\">Passaparola<\/option><\/select><\/span>\n\t\t<\/p>\n\t<\/div>\n<\/div>\n<div style=\"font-size: 13px;\">\n\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"privacy\"><span class=\"wpcf7-form-control wpcf7-acceptance\"><span class=\"wpcf7-list-item\"><label><input type=\"checkbox\" name=\"privacy\" value=\"1\" aria-invalid=\"false\" \/><span class=\"wpcf7-list-item-label\">Dichiaro di aver preso visione dell\u2019informativa relativa al trattamento dei miei dati personali inseriti nel form contatti - <a href=\"https:\/\/qualificagroup.it\/consulenza\/wp-content\/uploads\/2025\/02\/Informativa-Form-Contatti.pdf\" target=\"_blank\">Privacy Policy<\/a>.<\/span><\/label><\/span><\/span><\/span><br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"newsletter\"><span class=\"wpcf7-form-control wpcf7-acceptance optional\"><span class=\"wpcf7-list-item\"><label><input type=\"checkbox\" name=\"newsletter\" value=\"1\" aria-invalid=\"false\" \/><span class=\"wpcf7-list-item-label\">Presto il consenso per l\u2019invio di newsletter informative correlate al servizio gi\u00e0 acquistato o per il quale \u00e8 stata chiesta l\u2019informazione.<\/span><\/label><\/span><\/span><\/span><br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"adv\"><span class=\"wpcf7-form-control wpcf7-acceptance optional\"><span class=\"wpcf7-list-item\"><label><input type=\"checkbox\" name=\"adv\" value=\"1\" aria-invalid=\"false\" \/><span class=\"wpcf7-list-item-label\">Presto il consenso per l\u2019invio di newsletter informative relativamente alla pubblicizzazione di ulteriori servizi anche se non correlati a quelli gi\u00e0 acquistati o per i quali si \u00e8 chiesta l\u2019informazione.<\/span><\/label><\/span><\/span><\/span>\n\t<\/p>\n<\/div>\n<div class=\"bt_bb_cf7_row\">\n\t<div class=\"bt_bb_cf7_element bt_bb_cf7_button\">\n\t\t<p><input class=\"wpcf7-form-control wpcf7-submit has-spinner\" type=\"submit\" value=\"I N V I A\" \/>\n\t\t<\/p>\n\t<\/div>\n<\/div>\n<div class=\"wpcf7-response-output\" aria-hidden=\"true\"><\/div>\n<\/form>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><div class=\"bt_bb_row \"  data-bt-override-class=\"{}\"><div class=\"bt_bb_row_holder\" ><\/div><\/div><\/div><!-- cell_inner --><\/div><!-- cell --><\/div><!-- port --><\/section><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\t\t\t\t\t\t\t\tTaking seamless key performance indicators offline to maximise the long tail. Keeping your eye on the ball while performing a deep dive.\t\t\t\t<\/p>\n","protected":false},"author":1,"featured_media":19242,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[218],"tags":[225,226],"post_folder":[],"class_list":["post-19343","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-certificazioni-iso","tag-certificazione-iso-13485","tag-iso-13485"],"_links":{"self":[{"href":"https:\/\/qualificagroup.it\/consulenza\/wp-json\/wp\/v2\/posts\/19343","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/qualificagroup.it\/consulenza\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/qualificagroup.it\/consulenza\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/qualificagroup.it\/consulenza\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/qualificagroup.it\/consulenza\/wp-json\/wp\/v2\/comments?post=19343"}],"version-history":[{"count":0,"href":"https:\/\/qualificagroup.it\/consulenza\/wp-json\/wp\/v2\/posts\/19343\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/qualificagroup.it\/consulenza\/wp-json\/wp\/v2\/media\/19242"}],"wp:attachment":[{"href":"https:\/\/qualificagroup.it\/consulenza\/wp-json\/wp\/v2\/media?parent=19343"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/qualificagroup.it\/consulenza\/wp-json\/wp\/v2\/categories?post=19343"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/qualificagroup.it\/consulenza\/wp-json\/wp\/v2\/tags?post=19343"},{"taxonomy":"post_folder","embeddable":true,"href":"https:\/\/qualificagroup.it\/consulenza\/wp-json\/wp\/v2\/post_folder?post=19343"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}