{"id":12742,"date":"2025-07-30T07:21:40","date_gmt":"2025-07-30T07:21:40","guid":{"rendered":"https:\/\/mdxcro.com\/services\/soluzioni-cliniche-nel-settore-delle-tecnologie-mediche\/"},"modified":"2026-08-17T13:11:20","modified_gmt":"2026-08-17T13:11:20","slug":"soluzioni-cliniche-medtech","status":"publish","type":"service","link":"https:\/\/mdxcro.com\/it\/servizi\/soluzioni-cliniche-medtech\/","title":{"rendered":"Soluzioni Cliniche MedTech"},"content":{"rendered":"\n<section id=\"block_2b9bd2a46dabd47023dae33e12bf772e\" class=\"hero\">\n    <div class=\"hero--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/04\/sectors-MDx-CRO-2.webp\" fetchpriority=\"high\" class=\"no-lazy\" alt=\"\" \/>\n    <\/div>\n        <div class=\"container\">\n                <div class=\"content\">\n                                    <h1 class=\"title\">Soluzioni Cliniche MedTech<\/h1>\n            \n                            <div class=\"description\"><p>Accelera i Tuoi Studi MedTech, dalla Progettazione alla Presentazione Globale<br \/>\n<span style=\"font-weight: 400;\">MDx fornisce <a href=\"https:\/\/mdxcro.com\/servizi\/clinical-research\/\">ricerca clinica<\/a> e indagini conformi a ISO 14155\/20916 guidate da esperti per IVD e dispositivi medici\u2014supportando MDR, IVDR, FDA IDE e approvazioni globali<\/span><\/p>\n<\/div>\n            \n                            <div class=\"button-wrapper\">\n                                            <a href=\"https:\/\/mdxcro.com\/it\/contatti\/?utm_source=medtech_clinical_solutions\" class=\"button button--default\" target=\"_self\">\n                            Prenota una Chiamata Conoscitiva                        <\/a>\n                                            <a href=\"https:\/\/mdxcro.com\/it\/contatti\/?utm_source=services&#038;utm_content=MedTech_Clinical_Solutions\" class=\"button button--secondary\" target=\"_self\">\n                            Pianifica il tuo Studio con MDx                        <\/a>\n                                    <\/div>\n                            <\/div>\n            <\/div>\n<\/section>\n\n<section id=\"block_20b80f9db5289fb0e8d4acfc0d1698a3\" class=\"text-image\" style=\"margin-top: var(--wp--preset--spacing--xxlarge); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Il Tuo Partner <span class=\"blue-highlight\">CRO<\/span> MedTech<\/h2><div class=\"description wysiwyg\"><p><span style=\"font-weight: 400\">In MDx, offriamo <\/span><b>soluzioni cliniche end-to-end<\/b><span style=\"font-weight: 400\">  sia per produttori di IVD che di dispositivi medici. Dalla   <\/span><b>progettazione del protocollo e fattibilit\u00e0<\/b><span style=\"font-weight: 400\"> alle <\/span><b>presentazioni normative e monitoraggio<\/b><span style=\"font-weight: 400\">, garantiamo il successo clinico\u2014pi\u00f9 veloce, pi\u00f9 intelligente e conforme a livello globale.<\/span><\/p>\n<p><b>Scelto da sponsor globali<\/b><span style=\"font-weight: 400\"> tra cui i primi 10 produttori di IVD e MedTech.<\/span><br \/>\n<br \/>Se stai confrontando partner clinici, usa la nostra <a href=\"https:\/\/mdxcro.com\/how-to-qualify-medical-device-cro\/\">checklist di qualificazione CRO per dispositivi medici<\/a> per valutare esperienza rilevante, sistemi di qualit\u00e0, personale, controlli dei dati e supervisione prima di emettere una RFP.<\/p>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/Untitled-106.jpg\" alt=\"Thorough checklist and documents process for Medical Device companies, focusing on compliance, quality assurance, and accelerating MedTech innovation.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_64fc96a8945a59d793e5201ac23b5d13\" class=\"text-image text-image--reverse\" style=\"margin-top: var(--wp--preset--spacing--xxlarge); margin-bottom: var(--wp--preset--spacing--xxlarge); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Perch\u00e9 gli Sponsor Scelgono <span class=\"blue-highlight\">MDx<\/span> <\/h2><div class=\"description wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Operazioni Cliniche ISO 14155 \/ ISO 20916<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Supporto completo EU MDR, IVDR e FDA IDE<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Sponsor delegato e Rappresentante Legale UE<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Monitoraggio interno, biostatistica, gestione dati<\/span><\/li>\n<li style=\"font-weight: 400\">eCRF, eTMF, QMS e preparazione agli audit<\/li>\n<\/ul>\n<p>Gli sponsor che valutano un partner per indagini cliniche devono verificare come la ISO 14155 viene implementata nella pianificazione dello studio, monitoraggio, segnalazione di sicurezza, gestione dei dati e supervisione. <a href=\"https:\/\/mdxcro.com\/iso-14155-compliant-medtech-cro-mdr\/\">La nostra guida di qualificazione CRO ISO 14155 <\/a>elenca le evidenze e le domande da includere nella valutazione.<\/p>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDxCorporate_alta-calidad-5-scaled.jpg\" alt=\"Innovative MDX medical technology at work with a smiling woman healthcare professional during an online meeting. Focus on advancing MedTech solutions and digital health innovation.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_0720561c4fd330ec2e55d68cacf7386b\" class=\"content-columns content-columns--four-columns \" style=\"\">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                    <h2 class=\"title\">I Nostri Servizi Clinici<\/h2>\n                                                    <div class=\"description wysiwyg\">\n                        <p>Per aiuto nel determinare se uno studio proposto rientra nell&#8217;Articolo 62, Articolo 74 o Articolo 82 del MDR, consulta la nostra <a href=\"https:\/\/mdxcro.com\/mdcg-2021-6-clinical-investigations-proof-of-concept\/\">guida alle indagini cliniche MDCG 2021-6 Rev. 1.<\/a><\/p>\n<p>Per le indagini su dispositivi medici nell&#8217;UE, la conformit\u00e0 normativa richiede anche un processo definito per la segnalazione di SAE e difetti del dispositivo. La nostra panoramica sulla <a href=\"https:\/\/mdxcro.com\/safety-reporting-in-clinical-investigations-with-medical-devices-mdcg-2020-10-rev-1\/\">segnalazione di sicurezza MDCG 2020-10\/1<\/a> spiega i criteri di segnalazione applicabili, le tempistiche e il processo di presentazione all&#8217;autorit\u00e0 competente. <\/p>\n<p>Il pacchetto di domanda deve includere anche un Investigator&#8217;s Brochure che presenti informazioni su dispositivo, evidenze e rischi in forma chiara, equilibrata e tracciabile. Usa la nostra <a href=\"https:\/\/mdxcro.com\/mdr-investigators-brochure-consolidating-mdcg-2024-5-and-iso-14155-for-medical-devices\/\">checklist Investigator&#8217;s Brochure MDCG 2024-5<\/a> prima della presentazione. <\/p>\n                    <\/div>\n                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Strategia e Pianificazione<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li><span style=\"font-weight: 400\">Strategia Clinica<\/span><\/li>\n<li><span style=\"font-weight: 400\">Fattibilit\u00e0 dello Studio e Selezione dei Centri<\/span><\/li>\n<li><span style=\"font-weight: 400\">Sviluppo del Protocollo (CIP \/ CPSP)<\/span><\/li>\n<li><span style=\"font-weight: 400\">Pianificazione della Gestione del Rischio<\/span><\/li>\n<li>\nI programmi che richiedono lavoro esplorativo, indagini di conferma e PMCF devono definire queste attivit\u00e0 all&#8217;interno di un <a href=\"https:\/\/mdxcro.com\/clinical-development-for-medical-devices-from-strategy-to-submission\/\">Piano di Sviluppo Clinico per Dispositivi Medici<\/a> documentato, con milestone e criteri di accettazione prospettici.<\/li>\n<li><span style=\"font-weight: 400\">Strategia Clinica<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-black\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Esecuzione e Supervisione<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li><span style=\"font-weight: 400\">Progettazione eCRF e Raccolta Dati<\/span><\/li>\n<li><span style=\"font-weight: 400\">Gestione eTMF<\/span><\/li>\n<li><span style=\"font-weight: 400\">Monitoraggio Centralizzato, On-site e Risk-Based<\/span><\/li>\n<li><span style=\"font-weight: 400\">Biostatistica e Gestione Dati<\/span><\/li>\n<li><span style=\"font-weight: 400\">Report di Avanzamento e Reportistica di Fine Studio, inclusi <a href=\"https:\/\/mdxcro.com\/clinical-investigation-report-medical-devices-2023-c163-06\/\">Report di Indagine Clinica e riassunti secondo EU MDR<\/a> e CPSR<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Normativa e Conformit\u00e0<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li><span style=\"font-weight: 400\">MDR, IVDR, FDA<\/span><\/li>\n<li><span style=\"font-weight: 400\">Presentazioni a Comitati Etici e Autorit\u00e0 Competenti (UE, UK, US), inclusi <a href=\"https:\/\/mdxcro.com\/clinical-investigation-submission-spain-aemps\/\">percorsi AEMPS e CEIm in Spagna<\/a><\/span><\/li>\n<li><span style=\"font-weight: 400\">Rappresentanza Legale UE\/UK<\/span><\/li>\n<li><span style=\"font-weight: 400\">Registrazione EUDAMED<\/span><\/li>\n<li><span style=\"font-weight: 400\">CAPA e Preparazione agli Audit<\/span><\/li>\n<li><span style=\"font-weight: 400\">Conformit\u00e0 GCP, ISO 14155\/20916<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Usabilit\u00e0 e Fattori Umani<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li><span style=\"font-weight: 400\">Studi Formativi e Sommativi<\/span><\/li>\n<li><span style=\"font-weight: 400\">Conformit\u00e0 IEC 62366 e FDA Human Factors<\/span><\/li>\n<li><span style=\"font-weight: 400\">Usabilit\u00e0 e Fattori Umani<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n            <\/div>\n<\/section>\n<section class=\"table\"><div class=\"container\"><div class=\"headline\">Tabella di Confronto CRO<\/div><div class=\"table-wrapper\"><div class=\"feature-column-wrapper\"><table class=\"feature-table\"><thead><tr><th class=\"feature-column\">Servizi CRO<\/th><\/tr><\/thead><tbody><tr><td class=\"feature-cell\">Gestione di Progetti Clinici<\/td><\/tr><tr><td class=\"feature-cell\">Sviluppo del Protocollo<\/td><\/tr><tr><td class=\"feature-cell\">Supporto Normativo (MDR e IVDR)<\/td><\/tr><tr><td class=\"feature-cell\">Audit di Studio (ISO 14155 \/ ISO 20916)<\/td><\/tr><tr><td class=\"feature-cell\">Rappresentante Legale UE\/UK<\/td><\/tr><tr><td class=\"feature-cell\">Biostatistica e Gestione Dati<\/td><\/tr><tr><td class=\"feature-cell\">Strumenti eTMF ed eCRF<\/td><\/tr><tr><td class=\"feature-cell\"><strong><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\">Conformit\u00e0 Clinica<\/mark><\/strong><\/td><\/tr><tr><td class=\"feature-cell\">SOP per GCP, ISO 14155 e ISO 20916<\/td><\/tr><tr><td class=\"feature-cell\">Team Clinico Multilingue<\/td><\/tr><tr><td class=\"feature-cell\"><strong><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\">Competenza e Coinvolgimento degli Stakeholder<\/mark><\/strong><\/td><\/tr><tr><td class=\"feature-cell\">MDR, IVDR, FDA, Strategia CA<\/td><\/tr><tr><td class=\"feature-cell\">Esperienza con Dispositivi Complessi ad Alto Rischio<\/td><\/tr><tr><td class=\"feature-cell\">Competenza in Software as a Medical Device (SaMD)<\/td><\/tr><tr><td class=\"feature-cell\">Coinvolgimento UE (EMA, MDCG, Organismi Notificati)<\/td><\/tr><\/tbody><\/table><\/div><div class=\"scrollable-columns-wrapper\"><table class=\"comparison-table\"><thead><tr><th class=\"column highlight\">MDx<\/th><th class=\"column\">Altre CRO<\/th><\/tr><\/thead><tbody><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">S\u00ec<\/td><td class=\"cell\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7064 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-blue.svg\" alt=\"\">S\u00ec<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Competenza interna<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Spesso esternalizzato<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Supporto specializzato<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Supporto generalista<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Condotti da esperti MDx<\/td><td class=\"cell\"><img decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Raramente offerto<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Incluso<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Disponibilit\u00e0 limitata<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Completamente interno<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Spesso esternalizzato<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Sistemi certificati<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Limitata<\/td><\/tr><tr><td class=\"cell highlight\"><\/td><td class=\"cell\"><\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Robusto e armonizzato<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Parziale<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">14+ Lingue<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Copertura limitata<\/td><\/tr><tr><td class=\"cell highlight\"><\/td><td class=\"cell\"><\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Track record comprovato<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Parziale<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Estesa<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Limitata<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Specializzata<\/td><td class=\"cell\"><img decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Raramente supportato<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Partecipazione attiva<\/td><td class=\"cell\"><img decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Nessun accesso diretto<\/td><\/tr><\/tbody><\/table><\/div><\/div><\/div><\/section>\n<section id=\"block_204a8df2b211eac9b82a2e81d04c7303\" class=\"content-columns content-columns--three-columns \" style=\"\">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                    <h2 class=\"title\">Aree Terapeutiche e Tecnologie<\/h2>\n                                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\"><span class=\"blue-highlight\">Competenza<\/span> Terapeutica <\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li><span style=\"font-weight: 400\">Oncologia<\/span><\/li>\n<li><span style=\"font-weight: 400\">Cardiovascolare<\/span><\/li>\n<li><span style=\"font-weight: 400\">Ortopedia e Odontoiatria<\/span><\/li>\n<li><span style=\"font-weight: 400\">Malattie infettive<\/span><\/li>\n<li><span style=\"font-weight: 400\">Cura delle Ferite<\/span><\/li>\n<li><span style=\"font-weight: 400\">Salute Riproduttiva<\/span><\/li>\n<li><span style=\"font-weight: 400\">Neurologia e Salute Mentale<\/span><\/li>\n<li><span style=\"font-weight: 400\">Terapia Intensiva<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Tecnologie<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">SaMD e Salute Digitale<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Dispositivi Impiantabili<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Tecnologie di Imaging<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Prodotti di Combinazione<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Diagnostica In Vitro (IVD): PCR, NGS, IHC, immunoassay, ecc.<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n                    <div class=\"button-wrapper\">\n                                    <a href=\"\/expertise\/therapeutic-areas\" class=\"button button--default\" target=\"_self\">\n                        Esplora Tutte le Aree Terapeutiche                     <\/a>\n                            <\/div>\n            <\/div>\n<\/section>\n\n<section id=\"block_72d17ed990c748a03674add864cd3cae\" class=\"text-image\" style=\"margin-top: var(--wp--preset--spacing--xxlarge); margin-bottom: var(--wp--preset--spacing--xxlarge); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Il Nostro Impatto Clinico<\/h2><div class=\"description wysiwyg\"><ul>\n<li><b>100% di successo<\/b><span style=\"font-weight: 400\"> nelle presentazioni di studi IVDR e MDR<\/span><\/li>\n<li><b>30+ studi complessi<\/b><span style=\"font-weight: 400\"> gestiti per Classe II\/III e IVD ad alto rischio<\/span><\/li>\n<li><b>60+<\/b><span style=\"font-weight: 400\"> presentazioni di studi delle prestazioni IVD in tutta Europa<\/span><\/li>\n<li><b>SaMD <\/b><span style=\"font-weight: 400\">e terapie digitali completamente gestiti fino alla presentazione<\/span><\/li>\n<\/ul>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/Untitled-12.jpg\" alt=\"Advanced healthcare professionals monitoring patient vitals with medical devices in a hospital setting, emphasizing MedTech innovation and clinical excellence.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_c8092b18ebb6b39fed2b96cea1496c2d\" class=\"charts\" style=\"\">\n    <div class=\"container\">\n\t\t  <h2 class=\"headline\">Tipi di Progetti che Gestiamo<\/h2>\n\t\n\t\t  \t\t<h3 class=\"subtitle\"> Studi di Performance IVD<\/h3>\n\t  \n\t  <div class=\"grid\">\n\t\t\t\t  <div\n\t\t\tclass=\"chart\"\n\t\t\tdata-chart=\"doughnut\"\n\t\t\tdata-colors=\"#0000f0, #2c59d9, #05a1b3, #8eebe1, #79c4bd\"\n\t\t\tdata-values=\"35.8, 25.5, 21.3, 9.2, 8.2\"\n\t\t\tdata-labels=\"Infezione\/Immunit\u00e0, CDx, Test Genetici, Marcatori Fisiologici, Altri\"\n\t\t\tdata-legend=\"true\">\n\t\t\t<canvas><\/canvas>\n\t\t  <\/div>\n\t\t\t\t  <div\n\t\t\tclass=\"chart\"\n\t\t\tdata-chart=\"doughnut\"\n\t\t\tdata-colors=\"#0000f0, #2c59d9, #05a1b3\"\n\t\t\tdata-values=\"85, 11, 4\"\n\t\t\tdata-labels=\"Classe C, Classe B, Classe D\"\n\t\t\tdata-legend=\"true\">\n\t\t\t<canvas><\/canvas>\n\t\t  <\/div>\n\t\t\t  <\/div>\n\t\t  \t\t<h3 class=\"subtitle\">Indagini Cliniche su Dispositivi Medici<\/h3>\n\t  \n\t  <div class=\"grid\">\n\t\t\t\t  <div\n\t\t\tclass=\"chart\"\n\t\t\tdata-chart=\"doughnut\"\n\t\t\tdata-colors=\"#0000f0, #2c59d9, #05a1b3, #8eebe1\"\n\t\t\tdata-values=\"62.5, 19.3, 8, 10.2\"\n\t\t\tdata-labels=\"Impiantabile, Generale, Impiantabile Attivo, Attivo\"\n\t\t\tdata-legend=\"true\">\n\t\t\t<canvas><\/canvas>\n\t\t  <\/div>\n\t\t\t\t  <div\n\t\t\tclass=\"chart\"\n\t\t\tdata-chart=\"doughnut\"\n\t\t\tdata-colors=\"#0000f0, #2c59d9, #05a1b3\"\n\t\t\tdata-values=\"29.6, 29.6, 40.8\"\n\t\t\tdata-labels=\"Classe III, Classe IIb, Classe IIa\"\n\t\t\tdata-legend=\"true\">\n\t\t\t<canvas><\/canvas>\n\t\t  <\/div>\n\t\t\t  <\/div>\n\t  <\/div>\n<\/section>\n<section id=\"block_57bb3ed57b6df7302e22716bdcdf2426\" class=\"testimonials\" style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/testimonials-bg.jpg&#039;);\">\n        <div class=\"testimonials--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/testimonials-bg.jpg\" alt=\"\" \/>\n    <\/div>\n    <div class=\"container\">\n                    <div class=\"headline\">Scelto da Sponsor Globali<\/div>\n        \n                    <div class=\"slider\">\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">&#8220;MDx delivered exceptional clinical execution for our MDR Class III implantable. Their ISO 14155 expertise, monitoring, and submission support helped us gain approval faster than expected.&#8221;<\/p>\n                                                                            <p class=\"author\">\n                                \u2014 VP, Clinical Affairs, Top 25 Global Device Manufacturer                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">&#8220;The team\u2019s ability to translate technical needs into compliant documentation was invaluable.&#8221;<\/p>\n                                                                            <p class=\"author\">\n                                \u2014 Director, Regulatory Affairs, SME MedTech Firm                                        \n                            <\/p>\n                                            <\/div>\n                            <\/div>\n        \n        <div class=\"footer\">\n            <div class=\"slider-dots\"><\/div>\n            <div class=\"button-wrapper\">\n                            <\/div>\n        <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_d0f61dbbb3f1af050f843488b3fe538f\" class=\"faqs\" style=\"\">\n    <div class=\"container\">\n    <div class=\"content\">\n      <div class=\"column\">\n                  <h2 class=\"headline\">Domande frequenti<\/h2>\n                          <a class=\"button button--quaternary\" href=\"https:\/\/mdxcro.com\/it\/contatti\/\" target=\"\">\n            Facci una Domanda          <\/a>\n              <\/div>\n      <div class=\"column\">\n                  <ul class=\"faq-list\">\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Gestite sia studi IVD che su Dispositivi Medici?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">S\u00ec \u2014 attraverso MDR, IVDR, FDA IDE, IRB e altro.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">MDx pu\u00f2 agire come Rappresentante Legale nell&#039;UE?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">S\u00ec \u2014 secondo MDR (Art. 62.2) e IVDR (Art. 58.4), possiamo agire come rappresentante legale o sponsor delegato. Forniamo anche servizi UK RP. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Supportate software as a medical device (SaMD)?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\"> S\u00ec. Supportiamo terapie digitali, diagnostica e studi SaMD con test di usabilit\u00e0 conformi a IEC 62366 e linee guida FDA Human Factors. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Qual \u00e8 la differenza tra clinical trial, investigation e performance study?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><i><span style=\"font-weight: 400\">Clinical trial<\/span><\/i><span style=\"font-weight: 400\"> = termine generale<\/span><span style=\"font-weight: 400\"><br \/>\n<\/span><i><span style=\"font-weight: 400\">Clinical investigation<\/span><\/i><span style=\"font-weight: 400\"> = per dispositivi medici<\/span><span style=\"font-weight: 400\"><br \/>\n<\/span><i><span style=\"font-weight: 400\">Performance study<\/span><\/i><span style=\"font-weight: 400\"> = per IVD<br \/>\n<\/span><span style=\"font-weight: 400\">Supportiamo tutti \u2014 dalla fattibilit\u00e0 alle presentazioni complete.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                      <\/ul>\n              <\/div>\n    <\/div>\n  <\/div>\n<\/section>\n\n  <script type=\"application\/ld+json\">\n    {\"@context\":\"https:\/\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Gestite sia studi IVD che su Dispositivi Medici?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"S\u00ec \u2014 attraverso MDR, IVDR, FDA IDE, IRB e altro.\"}},{\"@type\":\"Question\",\"name\":\"MDx pu\u00f2 agire come Rappresentante Legale nell'UE?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"S\u00ec \u2014 secondo MDR (Art. 62.2) e IVDR (Art. 58.4), possiamo agire come rappresentante legale o sponsor delegato. 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