{"id":4520,"date":"2026-01-13T15:05:42","date_gmt":"2026-01-13T14:05:42","guid":{"rendered":"https:\/\/new.we4healthcare.com\/?page_id=4520"},"modified":"2026-03-09T09:44:21","modified_gmt":"2026-03-09T08:44:21","slug":"regulatory","status":"publish","type":"page","link":"https:\/\/we4healthcare.com\/it\/regulatory\/","title":{"rendered":"We4 Regulatory"},"content":{"rendered":"<div class=\"wp-block-group alignfull has-primary-background-color has-background is-layout-flow wp-container-core-group-is-layout-f3c7fa73 wp-block-group-is-layout-flow\" style=\"padding-top:0;padding-bottom:0\"><div class=\"wp-block-cover is-style-default\" style=\"min-height:60vh;aspect-ratio:unset;\"><video class=\"wp-block-cover__video-background intrinsic-ignore\" autoplay muted loop playsinline src=\"https:\/\/we4healthcare.com\/wp-content\/uploads\/2026\/02\/regulatory-cover.mp4\" style=\"object-position:37% 71%\" data-object-fit=\"cover\" data-object-position=\"37% 71%\"><\/video><span aria-hidden=\"true\" class=\"wp-block-cover__background has-background-dim-80 has-background-dim\" style=\"background-color:#007ea7\"><\/span><div class=\"wp-block-cover__inner-container has-global-padding is-layout-constrained wp-block-cover-is-layout-constrained\"><section class=\"wp-block-group alignfull is-style-default has-global-padding is-layout-constrained wp-container-core-group-is-layout-57f34cee wp-block-group-is-layout-constrained\" style=\"margin-top:0;margin-bottom:0\"><h1 class=\"wp-block-heading alignwide has-text-align-center animated fadeInUp has-base-color has-text-color has-link-color has-large-font-size wp-elements-14b4e85e8b942515c14e36ca60bcae23 translation-block\"><strong>La compliance resa semplice, <\/strong><br><strong>scalabile e intelligente<\/strong><\/h1>\n\n<p class=\"has-text-align-center animated fadeInUp delay-100ms has-base-color has-text-color has-base-font-size translation-block\">Guidiamo aziende <strong>MedTech, Life Sciences e Digital Health<\/strong> lungo l\u2019intero ciclo di vita regolatorio: dalla validazione alla certificazione e all\u2019eccellenza nel <br>post\u2011market.<\/p>\n\n<div class=\"wp-block-group alignwide has-global-padding is-layout-constrained wp-block-group-is-layout-constrained\"><div class=\"wp-block-group is-content-justification-center is-nowrap is-layout-flex wp-container-core-group-is-layout-23441af8 wp-block-group-is-layout-flex\"><div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><div class=\"wp-block-button is-style-fill\"><a class=\"wp-block-button__link has-main-color has-base-background-color has-text-color has-background has-link-color has-small-font-size has-custom-font-size wp-element-button\" href=\"#core-services\">esplorare i nostri servizi<\/a><\/div><\/div><\/div><\/div><\/section><\/div><\/div><\/div><div class=\"wp-block-group alignfull has-global-padding is-layout-constrained wp-container-core-group-is-layout-f9c26c94 wp-block-group-is-layout-constrained\" style=\"margin-top:0;margin-bottom:0;padding-top:var(--wp--preset--spacing--xx-large);padding-right:var(--wp--preset--spacing--medium);padding-bottom:var(--wp--preset--spacing--xx-large);padding-left:var(--wp--preset--spacing--medium)\"><div class=\"wp-block-group alignwide is-vertical is-content-justification-center is-layout-flex wp-container-core-group-is-layout-b032f303 wp-block-group-is-layout-flex\"><div class=\"wp-block-group has-global-padding is-layout-constrained wp-block-group-is-layout-constrained\"><p class=\"has-text-align-center has-secondary-color has-text-color translation-block\">Supportiamo le aziende di dispositivi medici nell\u2019orientarsi in un panorama regolatorio sempre pi\u00f9 complesso, garantendo la <strong>piena conformit\u00e0 <\/strong><br>e ottimizzando la ricerca clinica.<\/p><\/div><\/div><\/div><div class=\"wp-block-group alignfull has-global-padding is-layout-constrained wp-container-core-group-is-layout-36d49072 wp-block-group-is-layout-constrained\" style=\"margin-top:0;margin-bottom:0;padding-top:var(--wp--preset--spacing--medium);padding-right:var(--wp--preset--spacing--medium);padding-bottom:var(--wp--preset--spacing--medium);padding-left:var(--wp--preset--spacing--medium)\"><div class=\"wp-block-group alignwide is-vertical is-content-justification-center is-layout-flex wp-container-core-group-is-layout-b032f303 wp-block-group-is-layout-flex\"><div class=\"wp-block-group has-global-padding is-layout-constrained wp-block-group-is-layout-constrained\"><h2 class=\"wp-block-heading has-text-align-center has-main-color has-text-color\">Servizi principali<\/h2><\/div><\/div><\/div><div class=\"wp-block-group alignfull has-global-padding is-layout-constrained wp-container-core-group-is-layout-f9c26c94 wp-block-group-is-layout-constrained\" id=\"core-services\" style=\"margin-top:0;margin-bottom:0;padding-top:var(--wp--preset--spacing--xx-large);padding-right:var(--wp--preset--spacing--medium);padding-bottom:var(--wp--preset--spacing--xx-large);padding-left:var(--wp--preset--spacing--medium)\"><div class=\"wp-block-columns alignwide are-vertically-aligned-center is-layout-flex wp-container-core-columns-is-layout-010e51cd wp-block-columns-is-layout-flex\"><div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-container-core-column-is-layout-c7b3064f wp-block-column-is-layout-flow\"><div class=\"wp-block-group has-global-padding is-layout-constrained wp-container-core-group-is-layout-f5f3bcb8 wp-block-group-is-layout-constrained\"><h2 class=\"wp-block-heading\"><strong><strong><strong><strong>Gap Analysis &amp; Valutazione<\/strong><\/strong><\/strong><\/strong><\/h2>\n\n<p class=\"has-small-font-size translation-block\">Partiamo da una <strong>valutazione iniziale strutturata del vostro sistema di gestione della qualit\u00e0 e della documentazione regolatoria<\/strong> per comprendere il livello attuale di conformit\u00e0.<\/p>\n\n<p class=\"has-small-font-size translation-block\">Il nostro team esamina i materiali esistenti, individua le lacune regolatorie e definisce una <strong>roadmap di implementazione chiara<\/strong> allineata ai requisiti normativi.<\/p>\n\n<div style=\"height:11px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><div class=\"wp-block-button is-style-fill\"><a class=\"wp-block-button__link has-main-color has-text-color has-background has-link-color has-small-font-size has-custom-font-size wp-element-button\" href=\"https:\/\/we4healthcare.com\/it\/contact-us\/\" style=\"background-color:#e5f2f6\">Scopri di pi\u00f9<\/a><\/div><\/div><\/div><\/div>\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-container-core-column-is-layout-baeb3921 wp-block-column-is-layout-flow\" style=\"border-radius:5px;padding-top:var(--wp--preset--spacing--large);padding-right:var(--wp--preset--spacing--large);padding-bottom:var(--wp--preset--spacing--large);padding-left:var(--wp--preset--spacing--large)\"><ul class=\"wp-block-list is-style-list-check-circle\"><li class=\"has-small-font-size translation-block\"><strong>Valutazione iniziale e revisione documentale<\/strong><br>Revisione della documentazione esistente del QMS e dei relativi processi.<\/li>\n\n<li class=\"has-small-font-size translation-block\"><strong>Report di Gap Analysis<\/strong><br>Identificazione dettagliata delle lacune di conformit\u00e0 e delle aree di miglioramento.<\/li>\n\n<li class=\"has-small-font-size translation-block\"><strong>Roadmap di implementazione<\/strong><br>Piano strategico con linea del tempo, priorit\u00e0, milestone e pianificazione delle risorse.<\/li><\/ul><\/div><\/div><\/div><div class=\"wp-block-group alignfull has-tertiary-background-color has-background has-global-padding is-layout-constrained wp-container-core-group-is-layout-f9c26c94 wp-block-group-is-layout-constrained\" style=\"margin-top:0;margin-bottom:0;padding-top:var(--wp--preset--spacing--xx-large);padding-right:var(--wp--preset--spacing--medium);padding-bottom:var(--wp--preset--spacing--xx-large);padding-left:var(--wp--preset--spacing--medium)\"><div class=\"wp-block-columns alignwide are-vertically-aligned-center is-layout-flex wp-container-core-columns-is-layout-010e51cd wp-block-columns-is-layout-flex\"><div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-container-core-column-is-layout-baeb3921 wp-block-column-is-layout-flow\" style=\"border-radius:5px;padding-top:var(--wp--preset--spacing--large);padding-right:var(--wp--preset--spacing--large);padding-bottom:var(--wp--preset--spacing--large);padding-left:var(--wp--preset--spacing--large)\"><ul class=\"wp-block-list is-style-list-check-circle\"><li class=\"has-small-font-size translation-block\"><strong>Elaborazione del manuale della qualit\u00e0<\/strong><br>Creazione della documentazione di livello superiore che definisce la struttura del QMS.<\/li>\n\n<li class=\"has-small-font-size translation-block\"><strong>Elaborazione \/ adattamento di SOP<\/strong><br>Creazione o ottimizzazione delle Procedure Operative Standard.<\/li>\n\n<li class=\"has-small-font-size translation-block\"><strong>Erogazione di formazione<\/strong><br>Programmi di formazione erogati in presenza o a distanza per garantire un\u2019adozione efficace.<\/li>\n\n<li class=\"has-small-font-size translation-block\"><strong>Sistemi di CAPA e di controllo documentale<\/strong><br>Implementazione di processi di azione correttiva e di sistemi di gestione documentale.<\/li><\/ul><\/div>\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-container-core-column-is-layout-c7b3064f wp-block-column-is-layout-flow\"><div class=\"wp-block-group has-global-padding is-layout-constrained wp-container-core-group-is-layout-f5f3bcb8 wp-block-group-is-layout-constrained\"><h2 class=\"wp-block-heading\"><strong><strong><strong><strong><strong>Implementazione del sistema di gestione della qualit\u00e0 (ISO 13485)<\/strong><\/strong><\/strong><\/strong><\/strong><\/h2>\n\n<p class=\"has-small-font-size translation-block\">Supportiamo lo sviluppo e l\u2019implementazione di un <strong>Sistema di gestione della qualit\u00e0 conforme all\u2019ISO 13485<\/strong>, adattato alle dimensioni e alla struttura della vostra organizzazione.<\/p>\n\n<p class=\"has-small-font-size translation-block\">Il nostro approccio si concentra sulla creazione di <strong>processi di qualit\u00e0 pratici e sostenibili<\/strong> che si integrino in modo fluido con le operazioni quotidiane.<\/p>\n\n<div style=\"height:11px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><div class=\"wp-block-button is-style-fill\"><a class=\"wp-block-button__link has-main-color has-text-color has-background has-link-color has-small-font-size has-custom-font-size wp-element-button\" href=\"https:\/\/we4healthcare.com\/it\/contact-us\/\" style=\"background-color:#e5f2f6\">Scopri di pi\u00f9<\/a><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"wp-block-group alignfull has-global-padding is-layout-constrained wp-container-core-group-is-layout-f9c26c94 wp-block-group-is-layout-constrained\" style=\"margin-top:0;margin-bottom:0;padding-top:var(--wp--preset--spacing--xx-large);padding-right:var(--wp--preset--spacing--medium);padding-bottom:var(--wp--preset--spacing--xx-large);padding-left:var(--wp--preset--spacing--medium)\"><div class=\"wp-block-columns alignwide are-vertically-aligned-center is-layout-flex wp-container-core-columns-is-layout-010e51cd wp-block-columns-is-layout-flex\"><div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-container-core-column-is-layout-c7b3064f wp-block-column-is-layout-flow\"><div class=\"wp-block-group has-global-padding is-layout-constrained wp-container-core-group-is-layout-f5f3bcb8 wp-block-group-is-layout-constrained\"><h2 class=\"wp-block-heading\"><strong><strong><strong><strong><strong>Fascicolo tecnico \/ Documentazione tecnica<\/strong><\/strong><\/strong><\/strong><\/strong><\/h2>\n\n<p class=\"has-small-font-size translation-block\">Supportiamo le aziende nella preparazione della <strong>documentazione tecnica richiesta per la conformit\u00e0 regolatoria<\/strong>, garantendo che sicurezza, performance e progettazione del dispositivo siano adeguatamente documentate.<\/p>\n\n<div style=\"height:11px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><div class=\"wp-block-button is-style-fill\"><a class=\"wp-block-button__link has-main-color has-text-color has-background has-link-color has-small-font-size has-custom-font-size wp-element-button\" href=\"https:\/\/we4healthcare.com\/it\/contact-us\/\" style=\"background-color:#e5f2f6\">Scopri di pi\u00f9<\/a><\/div><\/div><\/div><\/div>\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-container-core-column-is-layout-baeb3921 wp-block-column-is-layout-flow\" style=\"border-radius:5px;padding-top:var(--wp--preset--spacing--large);padding-right:var(--wp--preset--spacing--large);padding-bottom:var(--wp--preset--spacing--large);padding-left:var(--wp--preset--spacing--large)\"><ul class=\"wp-block-list is-style-list-check-circle\"><li class=\"has-small-font-size translation-block\"><strong>Device Master Record (DMR)<\/strong><br>Documentazione completa delle specifiche del dispositivo e delle informazioni di produzione.<\/li>\n\n<li class=\"has-small-font-size translation-block\"><strong>Report di valutazione clinica (CER)<\/strong><br>Valutazione e analisi dei dati clinici a supporto della sicurezza e delle prestazioni del dispositivo.<\/li>\n\n<li class=\"has-small-font-size translation-block\"><strong>Documentazione software (IEC 62304)<\/strong><br>Preparazione della documentazione relativa al ciclo di vita del software per dispositivi basati su software.<\/li>\n\n<li class=\"has-small-font-size translation-block\"><strong>File di gestione del rischio<\/strong><br>Documentazione conforme ai requisiti di gestione del rischio di ISO 14971.<\/li><\/ul><\/div><\/div><\/div><div class=\"wp-block-group alignfull has-tertiary-background-color has-background has-global-padding is-layout-constrained wp-container-core-group-is-layout-f9c26c94 wp-block-group-is-layout-constrained\" style=\"margin-top:0;margin-bottom:0;padding-top:var(--wp--preset--spacing--xx-large);padding-right:var(--wp--preset--spacing--medium);padding-bottom:var(--wp--preset--spacing--xx-large);padding-left:var(--wp--preset--spacing--medium)\"><div class=\"wp-block-columns alignwide are-vertically-aligned-center is-layout-flex wp-container-core-columns-is-layout-010e51cd wp-block-columns-is-layout-flex\"><div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-container-core-column-is-layout-baeb3921 wp-block-column-is-layout-flow\" style=\"border-radius:5px;padding-top:var(--wp--preset--spacing--large);padding-right:var(--wp--preset--spacing--large);padding-bottom:var(--wp--preset--spacing--large);padding-left:var(--wp--preset--spacing--large)\"><ul class=\"wp-block-list is-style-list-check-circle\"><li class=\"has-small-font-size translation-block\"><strong>Giustificazione di classificazione<\/strong><br>Ragionamento regolatorio a supporto della classificazione del dispositivo.<\/li>\n\n<li class=\"has-small-font-size translation-block\"><strong>Completamento del checklist GSPR<\/strong><br>Preparazione del checklist relativo ai Requisiti Generali di Sicurezza e Prestazione.<\/li>\n\n<li class=\"has-small-font-size translation-block\"><strong>Dichiarazione di conformit\u00e0 (DoC)<\/strong><br>Supporto nella redazione della Dichiarazione di conformit\u00e0.<\/li>\n\n<li class=\"has-small-font-size translation-block\"><strong>Collegamento con l\u2019Organismo notificato<\/strong><br>Comunicazione continuativa e supporto durante gli scambi con l\u2019Organismo notificato.<\/li><\/ul><\/div>\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-container-core-column-is-layout-c7b3064f wp-block-column-is-layout-flow\"><div class=\"wp-block-group has-global-padding is-layout-constrained wp-container-core-group-is-layout-f5f3bcb8 wp-block-group-is-layout-constrained\"><h2 class=\"wp-block-heading\"><strong><strong><strong><strong><strong><strong>Supporto per la marcatura CE (MDR)<\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/h2>\n\n<p class=\"has-small-font-size translation-block\">Guidiamo i produttori lungo il <strong>processo di marcatura CE secondo il regolamento MDR<\/strong>, garantendo che la documentazione regolatoria e i processi soddisfino le aspettative degli Organismi notificati.<\/p>\n\n<div style=\"height:11px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><div class=\"wp-block-button is-style-fill\"><a class=\"wp-block-button__link has-main-color has-text-color has-background has-link-color has-small-font-size has-custom-font-size wp-element-button\" href=\"https:\/\/we4healthcare.com\/it\/contact-us\/\" style=\"background-color:#e5f2f6\">Scopri di pi\u00f9<\/a><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"wp-block-group alignfull has-global-padding is-layout-constrained wp-container-core-group-is-layout-f9c26c94 wp-block-group-is-layout-constrained\" style=\"margin-top:0;margin-bottom:0;padding-top:var(--wp--preset--spacing--xx-large);padding-right:var(--wp--preset--spacing--medium);padding-bottom:var(--wp--preset--spacing--xx-large);padding-left:var(--wp--preset--spacing--medium)\"><div class=\"wp-block-columns alignwide are-vertically-aligned-center is-layout-flex wp-container-core-columns-is-layout-010e51cd wp-block-columns-is-layout-flex\"><div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-container-core-column-is-layout-c7b3064f wp-block-column-is-layout-flow\"><div class=\"wp-block-group has-global-padding is-layout-constrained wp-container-core-group-is-layout-f5f3bcb8 wp-block-group-is-layout-constrained\"><h2 class=\"wp-block-heading\"><strong><strong><strong><strong><strong><strong>Servizi aggiuntivi<\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/h2>\n\n<p class=\"has-small-font-size\">Forniamo inoltre supporto regolatorio complementare per rafforzare la conformit\u00e0 e la prontezza operativa.<\/p>\n\n<div style=\"height:11px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><div class=\"wp-block-button is-style-fill\"><a class=\"wp-block-button__link has-main-color has-text-color has-background has-link-color has-small-font-size has-custom-font-size wp-element-button\" href=\"https:\/\/we4healthcare.com\/it\/contact-us\/\" style=\"background-color:#e5f2f6\">Scopri di pi\u00f9<\/a><\/div><\/div><\/div><\/div>\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-container-core-column-is-layout-baeb3921 wp-block-column-is-layout-flow\" style=\"border-radius:5px;padding-top:var(--wp--preset--spacing--large);padding-right:var(--wp--preset--spacing--large);padding-bottom:var(--wp--preset--spacing--large);padding-left:var(--wp--preset--spacing--large)\"><ul class=\"wp-block-list is-style-list-check-circle\"><li class=\"has-small-font-size translation-block\"><strong>Supporto alle audit di fornitore<\/strong><br>Valutazione e preparazione delle audit dei fornitori.<\/li>\n\n<li class=\"has-small-font-size translation-block\"><strong>Verifica e validazione del progetto<\/strong><br>Supporto nella pianificazione ed esecuzione delle attivit\u00e0 di verifica e validazione.<\/li>\n\n<li class=\"has-small-font-size translation-block\"><strong>Servizi di consulenza specialistica<\/strong><br>Competenze regolatorie disponibili in modalit\u00e0 consulenza o a giornata.<\/li><\/ul><\/div><\/div><\/div><div class=\"wp-block-group alignfull has-global-padding is-layout-constrained wp-container-core-group-is-layout-a760ea08 wp-block-group-is-layout-constrained\" style=\"margin-top:0px;margin-bottom:0px;padding-top:var(--wp--preset--spacing--xx-large);padding-right:var(--wp--preset--spacing--medium);padding-bottom:var(--wp--preset--spacing--xx-large);padding-left:var(--wp--preset--spacing--medium)\"><div class=\"wp-block-group is-layout-flow wp-container-core-group-is-layout-c7b3064f wp-block-group-is-layout-flow\"><h2 class=\"wp-block-heading has-text-align-center\"><strong>Aree principali<\/strong><\/h2><\/div>\n\n<div class=\"wp-block-group alignwide has-tertiary-background-color has-background has-global-padding is-layout-constrained wp-container-core-group-is-layout-5fbedae1 wp-block-group-is-layout-constrained\" style=\"border-radius:5px;padding-top:var(--wp--preset--spacing--large);padding-right:var(--wp--preset--spacing--large);padding-bottom:var(--wp--preset--spacing--large);padding-left:var(--wp--preset--spacing--large)\"><div class=\"wp-block-group has-global-padding is-layout-constrained wp-block-group-is-layout-constrained\"><div class=\"wp-block-group is-content-justification-space-between is-layout-flex wp-container-core-group-is-layout-9366075c wp-block-group-is-layout-flex\"><div class=\"wp-block-group is-vertical is-layout-flex wp-container-core-group-is-layout-4b827052 wp-block-group-is-layout-flex\"><p style=\"font-style:normal;font-weight:600\"><strong>Sviluppatori SaMD<\/strong><\/p>\n\n<div class=\"wp-block-group has-secondary-color has-text-color has-small-font-size has-global-padding is-layout-constrained wp-container-core-group-is-layout-f5f3bcb8 wp-block-group-is-layout-constrained\"><p class=\"translation-block\">Forniamo supporto regolatorio per <strong>Software as a Medical Device (SaMD)<\/strong>, coprendo l\u2019intero ciclo di sviluppo e conformit\u00e0.<\/p>\n\n<p class=\"translation-block\">Ci\u00f2 include l\u2019implementazione dei <strong>processi di ciclo di vita del software IEC 62304<\/strong>, le considerazioni relative alla cybersecurity, la gestione del rischio secondo ISO 14971 e la preparazione della documentazione di valutazione clinica.<\/p>\n\n<p class=\"translation-block\">Il supporto si estende tipicamente dalla <strong>gap analysis iniziale fino alla certificazione<\/strong>, in funzione del livello di prontezza del dispositivo.<\/p><\/div><\/div>\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><div class=\"wp-block-button is-style-button-light is-style-button-light--1\"><a class=\"wp-block-button__link has-background wp-element-button\" style=\"background-color:#e5f2f6\">avvia il tuo progetto<\/a><\/div><\/div><\/div>\n\n<hr class=\"wp-block-separator has-text-color has-border-light-color has-alpha-channel-opacity has-border-light-background-color has-background is-style-separator-thin\"\/><\/div>\n\n<div class=\"wp-block-group has-global-padding is-layout-constrained wp-block-group-is-layout-constrained\"><div class=\"wp-block-group is-content-justification-space-between is-layout-flex wp-container-core-group-is-layout-9366075c wp-block-group-is-layout-flex\"><div class=\"wp-block-group is-vertical is-layout-flex wp-container-core-group-is-layout-4b827052 wp-block-group-is-layout-flex\"><p style=\"font-style:normal;font-weight:600\"><strong>Produttori virtuali<\/strong><\/p>\n\n<p class=\"has-secondary-color has-text-color has-small-font-size translation-block\">Supporto per aziende che operano come <strong>produttori virtuali<\/strong>, che gestiscono catene di approvvigionamento senza possedere impianti produttivi.<\/p>\n\n<p class=\"has-secondary-color has-text-color has-small-font-size\">I servizi includono il controllo dei fornitori, l\u2019implementazione del controllo del progetto e lo sviluppo di sistemi di qualit\u00e0 conformi all\u2019ISO 13485, adattati a strutture organizzative snelle.<\/p><\/div>\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><div class=\"wp-block-button is-style-button-light is-style-button-light--2\"><a class=\"wp-block-button__link has-background wp-element-button\" style=\"background-color:#e5f2f6\">avvia il tuo progetto<\/a><\/div><\/div><\/div>\n\n<hr class=\"wp-block-separator has-text-color has-border-light-color has-alpha-channel-opacity has-border-light-background-color has-background is-style-separator-thin\"\/><\/div>\n\n<div class=\"wp-block-group has-global-padding is-layout-constrained wp-block-group-is-layout-constrained\"><div class=\"wp-block-group is-content-justification-space-between is-layout-flex wp-container-core-group-is-layout-9366075c wp-block-group-is-layout-flex\"><div class=\"wp-block-group is-vertical is-layout-flex wp-container-core-group-is-layout-4b827052 wp-block-group-is-layout-flex\"><p style=\"font-style:normal;font-weight:600\"><strong>Produttori di dispositivi medici<\/strong><\/p>\n\n<p class=\"has-secondary-color has-text-color has-small-font-size translation-block\">Supporto regolatorio e documentale per <strong>produttori di dispositivi medici di tutte le classi<\/strong>, inclusi dispositivi legacy in transizione verso il MDR.<\/p>\n\n<p class=\"has-secondary-color has-text-color has-small-font-size\">I servizi includono la preparazione della documentazione tecnica, le interazioni con gli Organismi notificati e l\u2019implementazione dei processi di sorveglianza post\u2011market.<\/p><\/div>\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><div class=\"wp-block-button is-style-button-light is-style-button-light--3\"><a class=\"wp-block-button__link has-background wp-element-button\" style=\"background-color:#e5f2f6\">avvia il tuo progetto<\/a><\/div><\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>We support medical device companies in navigating an increasingly complex regulatory landscape, ensuring full compliance and streamlining clinical research. Core Services Gap Analysis &amp; Assessment We start with a structured initial assessment of your Quality Management System and regulatory documentation to understand your current level of compliance. 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