{"id":15389,"date":"2018-09-27T15:37:30","date_gmt":"2018-09-27T13:37:30","guid":{"rendered":"https:\/\/www.mathsly.it\/wordpress\/?page_id=15389"},"modified":"2026-07-23T15:59:16","modified_gmt":"2026-07-23T13:59:16","slug":"dispositivi-medici-validazione-statistica","status":"publish","type":"page","link":"https:\/\/www.mathsly.it\/wordpress\/dispositivi-medici-validazione-statistica\/","title":{"rendered":"Validazione Statistica per Dispositivi Medici"},"content":{"rendered":"\n<!-- ============================================================\n  MATHSLY RESEARCH \u2014 Dispositivi Medici: Validazione Statistica\n  Luglio 2026: Fraunces, hero navy\n  Layout s5: flex row come originale funzionante\n============================================================ -->\n\n<link rel=\"preconnect\" href=\"https:\/\/fonts.googleapis.com\">\n<link rel=\"preconnect\" href=\"https:\/\/fonts.gstatic.com\" crossorigin=\"\">\n<link href=\"https:\/\/fonts.googleapis.com\/css2?family=Fraunces:ital,opsz,wght@0,9..144,400;0,9..144,600;0,9..144,700;1,9..144,400;1,9..144,600;1,9..144,700&amp;family=DM+Sans:wght@300;400;500;600&amp;display=swap\" rel=\"stylesheet\">\n\n<style>\n.mdm *, .mdm *::before, .mdm *::after { box-sizing:border-box; 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}\n}\n<\/style>\n\n<div class=\"mdm\">\n\n  <p class=\"mdm-geo-text\">Mathsly Research offre consulenza statistica specializzata per la validazione di dispositivi medici e IVD. Servizi: studi di accuratezza diagnostica (sensibilit\u00e0, specificit\u00e0, ROC, AUC), sample size per dossier regolatori, Gauge R&amp;R, capability di processo (Cp, Cpk), studi CLSI (EP05, EP06, EP07, EP09), CER per MDR, Performance Evaluation per IVDR, documentazione statistica per FDA 510(k) e PMA, SPC. H-index 13. Risposta entro 24 ore.<\/p>\n\n  <!-- HERO (navy) -->\n  <section class=\"mdm-s1\">\n    <div class=\"mdm-s1-bar\"><\/div>\n    <div class=\"mdm-s1-glow a\"><\/div>\n    <div class=\"mdm-s1-glow b\"><\/div>\n    <div class=\"mdm-s1-wrap\">\n      <div>\n        <div class=\"mdm-eyebrow mdm-reveal\" style=\"color:rgba(34,159,164,.75);\">Dispositivi Medici \u2014 Validazione Statistica<\/div>\n        <h1 class=\"mdm-title hero mdm-s1-title mdm-lcp\">La statistica che porta il dispositivo <em>sul mercato.<\/em><\/h1>\n        <p class=\"mdm-s1-sub mdm-reveal d1\">Consulenza statistica specializzata per aziende med-tech, startup e team R&amp;D. Dalla progettazione degli studi di validazione alla documentazione tecnica per MDR, IVDR e FDA \u2014 con rigore scientifico e orientamento regolatorio.<\/p>\n        <div class=\"mdm-s1-btns mdm-reveal d2\">\n          <a class=\"mdm-btn solid\" href=\"https:\/\/www.mathsly.it\/wordpress\/contatti\/\">Richiedi una consulenza<\/a>\n          <a class=\"mdm-btn outline-white\" href=\"https:\/\/www.mathsly.it\/wordpress\/prenotazione-appuntamento\/\">Prenota una call \u2192<\/a>\n        <\/div>\n      <\/div>\n      <div class=\"mdm-diff-list mdm-reveal d1\">\n        <div class=\"mdm-diff-item\">\n          <div class=\"mdm-diff-ico\">&#x1f1ea;&#x1f1fa;<\/div>\n          <div>\n            <div class=\"mdm-diff-name\">MDR \u00b7 IVDR \u00b7 FDA 510(k) e PMA<\/div>\n            <div class=\"mdm-diff-desc\">Documentazione statistica conforme ai requisiti regolatori europei e americani, pronta per il Technical File e il dossier FDA.<\/div>\n          <\/div>\n        <\/div>\n        <div class=\"mdm-diff-item\">\n          <div class=\"mdm-diff-ico\">&#x1f52c;<\/div>\n          <div>\n            <div class=\"mdm-diff-name\">Standard CLSI per dispositivi IVD<\/div>\n            <div class=\"mdm-diff-desc\">Protocolli EP05, EP06, EP07, EP09 per imprecisione, linearit\u00e0, interferenza e comparabilit\u00e0 \u2014 conformi a IVDR e ISO 13485.<\/div>\n          <\/div>\n        <\/div>\n        <div class=\"mdm-diff-item\">\n          <div class=\"mdm-diff-ico\">&#x1f4d0;<\/div>\n          <div>\n            <div class=\"mdm-diff-name\">Sample size giustificato per Notified Body<\/div>\n            <div class=\"mdm-diff-desc\">Calcolo del campione documentato per studi diagnostici, di equivalenza e non-inferiorit\u00e0 \u2014 difendibile in fase di submission.<\/div>\n          <\/div>\n        <\/div>\n      <\/div>\n    <\/div>\n  <\/section>\n\n  <!-- KPI BAR -->\n  <div class=\"mdm-kpi\">\n    <div class=\"mdm-kpi-inner\">\n      <div class=\"mdm-kpi-item\"><div class=\"mdm-kpi-val\">12+ anni \u00b7 H-index 13<\/div><div class=\"mdm-kpi-label\">Esperienza scientifica verificabile<\/div><\/div>\n      <div class=\"mdm-kpi-item\"><div class=\"mdm-kpi-val\">MDR \u00b7 IVDR \u00b7 FDA<\/div><div class=\"mdm-kpi-label\">Documentazione per dossier regolatori<\/div><\/div>\n      <div class=\"mdm-kpi-item\"><div class=\"mdm-kpi-val\">CLSI \u00b7 ISO 13485<\/div><div class=\"mdm-kpi-label\">Standard per dispositivi diagnostici e IVD<\/div><\/div>\n      <div class=\"mdm-kpi-item\"><div class=\"mdm-kpi-val\">Entro 24h<\/div><div class=\"mdm-kpi-label\">Valutazione preliminare del progetto<\/div><\/div>\n    <\/div>\n  <\/div>\n\n  <!-- MDR (bg) -->\n  <section class=\"mdm-s2\">\n    <div class=\"mdm-s2-wrap\">\n      <div class=\"mdm-s2-left mdm-reveal\">\n        <div class=\"mdm-eyebrow\">Contesto regolatorio<\/div>\n        <h2 class=\"mdm-title lg\">Statistica e regolatorio <em>sono inseparabili.<\/em><\/h2>\n        <p>Con l&#8217;entrata in vigore del Regolamento MDR (EU 2017\/745) e IVDR (EU 2017\/746), i requisiti statistici per la validazione dei dispositivi medici sono diventati significativamente pi\u00f9 stringenti. Non basta pi\u00f9 &#8220;fare i test&#8221; \u2014 serve dimostrare con dati robusti e documentazione statistica tracciabile che il dispositivo \u00e8 sicuro ed efficace.<\/p>\n        <p>La statistica non \u00e8 un adempimento burocratico: \u00e8 parte integrante del processo di sviluppo. Un&#8217;analisi pianificata male \u2014 sample size sottodimensionato, endpoint sbagliato, metodo non appropriato \u2014 pu\u00f2 compromettere l&#8217;intera strategia regolatoria e ritardare l&#8217;accesso al mercato.<\/p>\n      <\/div>\n      <div class=\"mdm-reg-cards\">\n        <div class=\"mdm-reg-card mdm-reveal\">\n          <div class=\"mdm-reg-ico\">&#x1f1ea;&#x1f1fa;<\/div>\n          <div>\n            <div class=\"mdm-reg-label\">Europa<\/div>\n            <div class=\"mdm-reg-title\">MDR (EU 2017\/745) e IVDR (EU 2017\/746)<\/div>\n            <p class=\"mdm-reg-desc\">Supporto statistico per la Clinical Evaluation, Performance Evaluation e PMCF \u2014 documentazione conforme ai requisiti del Technical File e del Summary of Safety and Clinical Performance (SSCP).<\/p>\n          <\/div>\n        <\/div>\n        <div class=\"mdm-reg-card mdm-reveal d1\">\n          <div class=\"mdm-reg-ico\">&#x1f1fa;&#x1f1f8;<\/div>\n          <div>\n            <div class=\"mdm-reg-label\">USA<\/div>\n            <div class=\"mdm-reg-title\">FDA 510(k), De Novo e PMA<\/div>\n            <p class=\"mdm-reg-desc\">Analisi statistica per Premarket Notification 510(k) e Premarket Approval (PMA) \u2014 inclusa pianificazione del sample size, analisi di equivalenza\/non-inferiorit\u00e0 e documentazione secondo le FDA Statistical Guidance.<\/p>\n          <\/div>\n        <\/div>\n        <div class=\"mdm-reg-card mdm-reveal d2\">\n          <div class=\"mdm-reg-ico\">&#x1f4d0;<\/div>\n          <div>\n            <div class=\"mdm-reg-label\">Standard internazionali<\/div>\n            <div class=\"mdm-reg-title\">ISO 13485, ISO 14971, CLSI<\/div>\n            <p class=\"mdm-reg-desc\">Analisi statistica conforme agli standard ISO per la gestione della qualit\u00e0 e del rischio \u2014 inclusi gli standard CLSI per la valutazione delle prestazioni dei dispositivi diagnostici in vitro (IVD).<\/p>\n          <\/div>\n        <\/div>\n      <\/div>\n    <\/div>\n  <\/section>\n\n  <!-- SERVIZI (navy) -->\n  <section class=\"mdm-s3\">\n    <div class=\"mdm-s3-wrap\">\n      <div class=\"mdm-s3-header mdm-reveal\">\n        <div class=\"mdm-eyebrow\" style=\"color:rgba(34,159,164,.70);\">Servizi<\/div>\n        <h2 class=\"mdm-title lg\">Cosa facciamo per <em>dispositivi medici.<\/em><\/h2>\n        <p>Copertura statistica completa del ciclo di vita del dispositivo \u2014 dallo studio di fattibilit\u00e0 alla sorveglianza post-market, con documentazione pronta per il dossier regolatorio MDR, IVDR e FDA.<\/p>\n      <\/div>\n      <div class=\"mdm-svc-grid\">\n        <div class=\"mdm-svc-card mdm-reveal\">\n          <div class=\"mdm-svc-tag\">Accuratezza diagnostica<\/div>\n          <div class=\"mdm-svc-title\">Studi di accuratezza diagnostica e performance<\/div>\n          <p class=\"mdm-svc-desc\">Pianificazione e analisi di studi per la valutazione delle performance diagnostiche \u2014 sensibilit\u00e0, specificit\u00e0, curve ROC e accordo interlaboratorio conforme agli standard STARD e CLSI.<\/p>\n          <ul class=\"mdm-svc-list\">\n            <li>Calcolo di sensibilit\u00e0, specificit\u00e0, VPP, VPN con IC<\/li>\n            <li>Analisi ROC e AUC con intervalli di confidenza<\/li>\n            <li>Studi di concordanza (Cohen&#8217;s kappa, Bland-Altman)<\/li>\n            <li>Analisi di accordo interlaboratorio e inter-rater (ICC)<\/li>\n            <li>Conformit\u00e0 alle linee guida STARD e CLSI EP<\/li>\n          <\/ul>\n        <\/div>\n        <div class=\"mdm-svc-card mdm-reveal d1\">\n          <div class=\"mdm-svc-tag\">Pianificazione studi<\/div>\n          <div class=\"mdm-svc-title\">Disegno degli studi e calcolo del campione<\/div>\n          <p class=\"mdm-svc-desc\">Progettazione statistica degli studi di validazione \u2014 dalla definizione degli endpoint al calcolo del sample size giustificato per Notified Body e FDA, fino alla strategia di analisi.<\/p>\n          <ul class=\"mdm-svc-list\">\n            <li>Calcolo del sample size documentato per dossier regolatorio<\/li>\n            <li>Studi di equivalenza e non-inferiorit\u00e0<\/li>\n            <li>Disegno adattivo e sequential testing<\/li>\n            <li>Randomizzazione e stratificazione<\/li>\n            <li>Piano di analisi statistica (SAP) pre-studio<\/li>\n          <\/ul>\n        <\/div>\n        <div class=\"mdm-svc-card mdm-reveal d2\">\n          <div class=\"mdm-svc-tag\">Qualit\u00e0 e processo<\/div>\n          <div class=\"mdm-svc-title\">Controllo statistico di processo e qualit\u00e0<\/div>\n          <p class=\"mdm-svc-desc\">Analisi della capability di processo, controllo statistico della qualit\u00e0 (SPC) e verifica della riproducibilit\u00e0 e ripetibilit\u00e0 di misurazioni strumentali per ISO 13485.<\/p>\n          <ul class=\"mdm-svc-list\">\n            <li>Analisi Gauge R&amp;R (ripetibilit\u00e0 e riproducibilit\u00e0)<\/li>\n            <li>Indici di capability (Cp, Cpk, Pp, Ppk)<\/li>\n            <li>Controllo statistico di processo (SPC) \u2014 carte di controllo<\/li>\n            <li>Analisi di affidabilit\u00e0 (Weibull) e FMEA statistica<\/li>\n            <li>Analisi della varianza per studi di verifica e validazione<\/li>\n          <\/ul>\n        <\/div>\n      <\/div>\n      <div class=\"mdm-svc-grid two\">\n        <div class=\"mdm-svc-card mdm-reveal\">\n          <div class=\"mdm-svc-tag\">Clinical Evaluation MDR<\/div>\n          <div class=\"mdm-svc-title\">Clinical Evaluation e PMCF per MDR<\/div>\n          <p class=\"mdm-svc-desc\">Supporto statistico per la Clinical Evaluation Report (CER) e per gli studi di Post-Market Clinical Follow-Up (PMCF) richiesti dal Regolamento MDR EU 2017\/745.<\/p>\n          <ul class=\"mdm-svc-list\">\n            <li>Analisi statistica per il Clinical Evaluation Report (CER)<\/li>\n            <li>Pianificazione e analisi degli studi PMCF<\/li>\n            <li>Meta-analisi di dati di letteratura per il dossier MDR<\/li>\n            <li>Analisi dei dati di sorveglianza post-market (PSUR\/PMSR)<\/li>\n          <\/ul>\n        <\/div>\n        <div class=\"mdm-svc-card mdm-reveal d1\">\n          <div class=\"mdm-svc-tag\">IVD e diagnostica in vitro<\/div>\n          <div class=\"mdm-svc-title\">Validazione dispositivi diagnostici in vitro (IVD)<\/div>\n          <p class=\"mdm-svc-desc\">Analisi statistica specializzata per dispositivi diagnostici in vitro \u2014 conformit\u00e0 agli standard CLSI per valutazione di imprecisione, bias, linearit\u00e0 e interferenze per IVDR.<\/p>\n          <ul class=\"mdm-svc-list\">\n            <li>Studi di imprecisione (CLSI EP05-A3)<\/li>\n            <li>Studi di bias e comparabilit\u00e0 metodi (CLSI EP09-A3)<\/li>\n            <li>Studi di linearit\u00e0 e intervallo di misura (CLSI EP06)<\/li>\n            <li>Studi di interferenza e carry-over (CLSI EP07, EP25)<\/li>\n          <\/ul>\n        <\/div>\n      <\/div>\n    <\/div>\n  <\/section>\n\n  <!-- METODI (bianco) -->\n  <section class=\"mdm-s4\">\n    <div class=\"mdm-s4-wrap\">\n      <div class=\"mdm-s4-header mdm-reveal\">\n        <div class=\"mdm-eyebrow\">Metodi e standard<\/div>\n        <h2 class=\"mdm-title lg\">Metodi statistici per ogni fase della <em>validazione.<\/em><\/h2>\n        <p>Ogni fase del processo di validazione richiede metodi statistici specifici. Utilizziamo gli standard internazionali di riferimento per garantire che ogni analisi sia difendibile di fronte a Notified Body, FDA e agenzie regolatorie nazionali.<\/p>\n      <\/div>\n      <div class=\"mdm-meth-grid\">\n        <div class=\"mdm-meth-card mdm-reveal\">\n          <div class=\"mdm-meth-cat\">Accuratezza diagnostica<\/div>\n          <div class=\"mdm-meth-title\">Performance diagnostica<\/div>\n          <ul class=\"mdm-meth-list\">\n            <li>Sensibilit\u00e0, specificit\u00e0, valori predittivi (VPP, VPN)<\/li>\n            <li>Curve ROC e confronto tra AUC (DeLong)<\/li>\n            <li>Likelihood ratio positivi e negativi<\/li>\n            <li>Indice di Youden per soglia ottimale<\/li>\n            <li>Standard: STARD 2015, CLSI EP12, ISO 15189<\/li>\n          <\/ul>\n        <\/div>\n        <div class=\"mdm-meth-card mdm-reveal d1\">\n          <div class=\"mdm-meth-cat\">Concordanza e accordo<\/div>\n          <div class=\"mdm-meth-title\">Metodi di accordo<\/div>\n          <ul class=\"mdm-meth-list\">\n            <li>Bland-Altman per metodi di misura continui<\/li>\n            <li>Cohen&#8217;s kappa e kappa pesato per variabili categoriali<\/li>\n            <li>ICC (Intraclass Correlation Coefficient)<\/li>\n            <li>Limiti di accordo con intervalli di confidenza bootstrap<\/li>\n            <li>Standard: CLSI EP09-A3, ISO 5725<\/li>\n          <\/ul>\n        <\/div>\n        <div class=\"mdm-meth-card mdm-reveal d2\">\n          <div class=\"mdm-meth-cat\">Sample size<\/div>\n          <div class=\"mdm-meth-title\">Pianificazione del campione<\/div>\n          <ul class=\"mdm-meth-list\">\n            <li>Sample size per sensibilit\u00e0\/specificit\u00e0 target<\/li>\n            <li>Sample size per studi di equivalenza e non-inferiorit\u00e0<\/li>\n            <li>Regola del 3 per studi di sicurezza (zero-event)<\/li>\n            <li>Disegni adattativi e sequential analysis<\/li>\n            <li>Analisi di potenza documentata per Notified Body e FDA<\/li>\n          <\/ul>\n        <\/div>\n        <div class=\"mdm-meth-card mdm-reveal\">\n          <div class=\"mdm-meth-cat\">Qualit\u00e0 e processo<\/div>\n          <div class=\"mdm-meth-title\">Controllo statistico<\/div>\n          <ul class=\"mdm-meth-list\">\n            <li>Gauge R&amp;R (ANOVA e metodo dei range) \u2014 AIAG MSA<\/li>\n            <li>Indici Cp, Cpk, Pp, Ppk per capability di processo<\/li>\n            <li>Carte di controllo Shewhart, CUSUM, EWMA<\/li>\n            <li>Analisi di affidabilit\u00e0 (Weibull, Kaplan-Meier)<\/li>\n            <li>Standard: ISO 13485, ISO 14971, AIAG MSA<\/li>\n          <\/ul>\n        <\/div>\n        <div class=\"mdm-meth-card mdm-reveal d1\">\n          <div class=\"mdm-meth-cat\">IVD \u2014 Standard CLSI<\/div>\n          <div class=\"mdm-meth-title\">Protocolli CLSI<\/div>\n          <ul class=\"mdm-meth-list\">\n            <li>EP05: Valutazione dell&#8217;imprecisione analitica<\/li>\n            <li>EP06: Valutazione della linearit\u00e0<\/li>\n            <li>EP07: Interferenze e effetti matrici<\/li>\n            <li>EP09: Comparabilit\u00e0 dei metodi di misura<\/li>\n            <li>EP15, EP17, EP25: Verifica utente, LoD, carry-over<\/li>\n          <\/ul>\n        <\/div>\n        <div class=\"mdm-meth-card mdm-reveal d2\">\n          <div class=\"mdm-meth-cat\">Documentazione regolatoria<\/div>\n          <div class=\"mdm-meth-title\">Dossier e reporting<\/div>\n          <ul class=\"mdm-meth-list\">\n            <li>SAP per studi clinici e di validazione<\/li>\n            <li>Tabelle e figure per Technical File MDR\/IVDR<\/li>\n            <li>Statistical Analysis Report (SAR) per FDA 510(k)\/PMA<\/li>\n            <li>Meta-analisi per Clinical Evaluation Report (CER)<\/li>\n            <li>Risposta a osservazioni di Notified Body e FDA<\/li>\n          <\/ul>\n        <\/div>\n      <\/div>\n    <\/div>\n  <\/section>\n\n  <!-- CHI CI CONTATTA (navy) \u2014 flex row come originale -->\n  <section class=\"mdm-s5\">\n    <div class=\"mdm-s5-glow\"><\/div>\n    <div class=\"mdm-s5-wrap\">\n      <div class=\"mdm-s5-col mdm-reveal\">\n        <div class=\"mdm-eyebrow\">Industria med-tech<\/div>\n        <h2 class=\"mdm-title lg\">Per aziende e <em>startup.<\/em><\/h2>\n        <p>Supporto completo per le fasi di sviluppo e validazione \u2014 dalla pianificazione degli studi alla documentazione per il dossier regolatorio MDR, IVDR e FDA.<\/p>\n        <div class=\"mdm-user-list\">\n          <div class=\"mdm-user-item\"><div class=\"mdm-user-ico\">&#x1f3ed;<\/div><div><div class=\"mdm-user-name\">Aziende med-tech in fase di sviluppo<\/div><div class=\"mdm-user-desc\">Pianificazione statistica degli studi di validazione fin dalla fase R&amp;D<\/div><\/div><\/div>\n          <div class=\"mdm-user-item\"><div class=\"mdm-user-ico\">&#x1f680;<\/div><div><div class=\"mdm-user-name\">Startup biomediche<\/div><div class=\"mdm-user-desc\">Supporto statistico agile per team con risorse limitate e scadenze stringenti<\/div><\/div><\/div>\n          <div class=\"mdm-user-item\"><div class=\"mdm-user-ico\">&#x1f4cb;<\/div><div><div class=\"mdm-user-name\">Uffici Regulatory Affairs<\/div><div class=\"mdm-user-desc\">Analisi e documentazione statistica per MDR, IVDR e FDA 510(k)\/PMA<\/div><\/div><\/div>\n          <div class=\"mdm-user-item\"><div class=\"mdm-user-ico\">&#x2705;<\/div><div><div class=\"mdm-user-name\">Team Quality Assurance<\/div><div class=\"mdm-user-desc\">SPC, Gauge R&amp;R, capability di processo e analisi di affidabilit\u00e0<\/div><\/div><\/div>\n        <\/div>\n      <\/div>\n      <div class=\"mdm-s5-divider\"><\/div>\n      <div class=\"mdm-s5-col mdm-reveal d1\">\n        <div class=\"mdm-eyebrow\">Ricerca e clinica<\/div>\n        <h2 class=\"mdm-title lg\">Per ricercatori e <em>clinici.<\/em><\/h2>\n        <p>Studi di validazione clinica, valutazione delle performance diagnostiche e analisi per la pubblicazione scientifica e il dossier MDR\/IVDR.<\/p>\n        <div class=\"mdm-user-list\">\n          <div class=\"mdm-user-item\"><div class=\"mdm-user-ico\">&#x1f3e5;<\/div><div><div class=\"mdm-user-name\">Ospedali e IRCCS<\/div><div class=\"mdm-user-desc\">Studi di performance e valutazione clinica di dispositivi diagnostici<\/div><\/div><\/div>\n          <div class=\"mdm-user-item\"><div class=\"mdm-user-ico\">&#x1f52c;<\/div><div><div class=\"mdm-user-name\">Laboratori e centri di ricerca<\/div><div class=\"mdm-user-desc\">Studi di accuratezza diagnostica e validazione di metodi analitici CLSI<\/div><\/div><\/div>\n          <div class=\"mdm-user-item\"><div class=\"mdm-user-ico\">&#x1f468;&#x200d;&#x2695;&#xfe0f;<\/div><div><div class=\"mdm-user-name\">Medici e ingegneri biomedici<\/div><div class=\"mdm-user-desc\">Supporto per tesi, pubblicazioni e validazione di prototipi<\/div><\/div><\/div>\n          <div class=\"mdm-user-item\"><div class=\"mdm-user-ico\">&#x1f48a;<\/div><div><div class=\"mdm-user-name\">Pharma con companion diagnostic<\/div><div class=\"mdm-user-desc\">Validazione statistica di IVD associati a farmaci oncologici e terapie mirate<\/div><\/div><\/div>\n        <\/div>\n      <\/div>\n    <\/div>\n  <\/section>\n\n  <!-- FAQ (bg) -->\n  <section class=\"mdm-s6\">\n    <div class=\"mdm-s6-wrap\">\n      <div class=\"mdm-s6-left mdm-reveal\">\n        <div class=\"mdm-eyebrow\">FAQ<\/div>\n        <h2 class=\"mdm-title lg\">Domande frequenti sulla <em>validazione statistica.<\/em><\/h2>\n        <p>Le domande pi\u00f9 comuni prima di avviare un progetto di validazione statistica per dispositivi medici.<\/p>\n        <a class=\"mdm-btn solid\" href=\"https:\/\/www.mathsly.it\/wordpress\/contatti\/\">Hai altre domande? Scrivici<\/a>\n      <\/div>\n      <div class=\"mdm-faq mdm-reveal d1\">\n        <div class=\"mdm-faq-item\">\n          <div class=\"mdm-faq-q\">Quando coinvolgere il biostatistico nel processo di sviluppo?<span class=\"mdm-faq-ico\">+<\/span><\/div>\n          <div class=\"mdm-faq-a\">Il prima possibile \u2014 idealmente prima di iniziare la raccolta dati. L&#8217;errore pi\u00f9 costoso \u00e8 raccogliere dati e poi scoprire che il campione \u00e8 insufficiente, l&#8217;endpoint sbagliato o il disegno non adeguato ai requisiti MDR\/FDA. Un SAP concordato prima dello studio evita sorprese costose in fase di submission al Notified Body.<\/div>\n        <\/div>\n        <div class=\"mdm-faq-item\">\n          <div class=\"mdm-faq-q\">Quanti campioni servono per uno studio di validazione diagnostica?<span class=\"mdm-faq-ico\">+<\/span><\/div>\n          <div class=\"mdm-faq-a\">Dipende dalla sensibilit\u00e0\/specificit\u00e0 attesa, dalla prevalenza della condizione nella popolazione target e dalla precisione richiesta per gli intervalli di confidenza. Per dispositivi diagnostici binari, campioni di 100\u2013300 soggetti per classe sono spesso necessari. I Notified Body e FDA richiedono che il sample size sia giustificato statisticamente nel dossier \u2014 lo facciamo noi con documentazione completa.<\/div>\n        <\/div>\n        <div class=\"mdm-faq-item\">\n          <div class=\"mdm-faq-q\">Che differenza c&#8217;\u00e8 tra MDR e IVDR per la statistica?<span class=\"mdm-faq-ico\">+<\/span><\/div>\n          <div class=\"mdm-faq-a\">MDR (EU 2017\/745) riguarda i dispositivi medici in generale e richiede una Clinical Evaluation basata su dati clinici. IVDR (EU 2017\/746) riguarda i dispositivi diagnostici in vitro e ha requisiti specifici per la performance analitica (imprecisione, bias, linearit\u00e0) e diagnostica \u2014 con protocolli CLSI come riferimento standard.<\/div>\n        <\/div>\n        <div class=\"mdm-faq-item\">\n          <div class=\"mdm-faq-q\">Cosa produce concretamente una consulenza statistica per un dispositivo medico?<span class=\"mdm-faq-ico\">+<\/span><\/div>\n          <div class=\"mdm-faq-a\">I deliverable tipici includono: SAP pre-studio, Statistical Analysis Report (SAR) con tabelle e figure pronti per il Technical File, giustificazione del sample size documentata, sezione statistica per il CER o Performance Evaluation Report, e risposte puntuali a osservazioni statistiche di Notified Body o FDA.<\/div>\n        <\/div>\n        <div class=\"mdm-faq-item\">\n          <div class=\"mdm-faq-q\">Supportate anche startup con budget limitati?<span class=\"mdm-faq-ico\">+<\/span><\/div>\n          <div class=\"mdm-faq-a\">S\u00ec. Lavoriamo anche su scope limitati \u2014 ad esempio solo il calcolo del sample size e la pianificazione dello studio, o solo la revisione critica di un&#8217;analisi gi\u00e0 condotta. Contattateci con le vostre scadenze e il budget disponibile: costruiamo insieme il supporto pi\u00f9 efficace possibile.<\/div>\n        <\/div>\n      <\/div>\n    <\/div>\n  <\/section>\n\n  <!-- CTA (navy) -->\n  <section class=\"mdm-s7\">\n    <div class=\"mdm-s7-wrap\">\n      <div class=\"mdm-eyebrow mdm-reveal\" style=\"justify-content:center; color:rgba(34,159,164,.70);\">Parliamo del tuo dispositivo<\/div>\n      <h2 class=\"mdm-title lg mdm-reveal d1\">Stai sviluppando un dispositivo medico e hai bisogno di <em>validazione statistica?<\/em><\/h2>\n      <p class=\"mdm-reveal d2\">Descrivici la tipologia di dispositivo, la fase di sviluppo e il contesto regolatorio di riferimento (MDR, IVDR, FDA). Valutiamo in 24 ore e ti proponiamo il piano statistico pi\u00f9 adatto.<\/p>\n      <div class=\"mdm-s7-btns mdm-reveal d2\">\n        <a class=\"mdm-btn solid-light\" href=\"https:\/\/www.mathsly.it\/wordpress\/contatti\/\">Richiedi una consulenza<\/a>\n        <a class=\"mdm-btn outline-light\" href=\"https:\/\/www.mathsly.it\/wordpress\/prenotazione-appuntamento\/\">Prenota una call<\/a>\n      <\/div>\n      <div class=\"mdm-related mdm-reveal d3\">\n        <span class=\"mdm-related-label\">Vedi anche<\/span>\n        <a class=\"mdm-related-link\" href=\"https:\/\/www.mathsly.it\/wordpress\/biostatistica-studi-clinici\/\">Biostatistica e Studi Clinici<\/a>\n        <a class=\"mdm-related-link\" href=\"https:\/\/www.mathsly.it\/wordpress\/advisory-metodologico-indipendente\/\">Advisory Indipendente<\/a>\n        <a class=\"mdm-related-link\" href=\"https:\/\/www.mathsly.it\/wordpress\/machine-learning\/\">Machine Learning<\/a>\n        <a class=\"mdm-related-link\" href=\"https:\/\/www.mathsly.it\/wordpress\/servizi\/\">Tutti i servizi<\/a>\n      <\/div>\n    <\/div>\n  <\/section>\n\n<\/div>\n\n<script>\n(function(){\n  var io = new IntersectionObserver(function(entries){\n    entries.forEach(function(e){\n      if(e.isIntersecting){ e.target.classList.add(\"up\"); io.unobserve(e.target); }\n    });\n  },{ threshold:0.07 });\n  document.querySelectorAll(\".mdm-reveal\").forEach(function(el){ io.observe(el); });\n  document.querySelectorAll(\".mdm-faq-item\").forEach(function(item){\n    item.querySelector(\".mdm-faq-q\").addEventListener(\"click\",function(){\n      var isOpen = item.classList.contains(\"open\");\n      document.querySelectorAll(\".mdm-faq-item\").forEach(function(i){ i.classList.remove(\"open\"); });\n      if(!isOpen) item.classList.add(\"open\");\n    });\n  });\n})();\n<\/script>\n","protected":false},"excerpt":{"rendered":"<p>Mathsly Research offre consulenza statistica specializzata per la validazione di dispositivi medici e IVD. Servizi: studi di accuratezza diagnostica (sensibilit\u00e0, specificit\u00e0, ROC, AUC), sample size per dossier regolatori, Gauge R&amp;R, capability di processo (Cp, Cpk), studi CLSI (EP05, EP06, EP07, EP09), CER per MDR, Performance Evaluation per IVDR, documentazione statistica per FDA 510(k) e PMA, &#8230; <a title=\"Validazione Statistica per Dispositivi Medici\" class=\"read-more\" href=\"https:\/\/www.mathsly.it\/wordpress\/dispositivi-medici-validazione-statistica\/\" aria-label=\"Per saperne di pi\u00f9 su Validazione Statistica per Dispositivi Medici\">Leggi tutto<\/a><\/p>\n","protected":false},"author":138,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-15389","page","type-page","status-publish"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.3 (Yoast SEO v28.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Validazione Statistica Dispositivi Medici \u2014 MDR, IVDR e FDA<\/title>\n<meta name=\"description\" content=\"Consulenza statistica per dispositivi medici. Accuratezza diagnostica, sample size, Gauge R&amp;R e Clinical Evaluation MDR, IVDR e FDA.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.mathsly.it\/wordpress\/dispositivi-medici-validazione-statistica\/\" \/>\n<meta property=\"og:locale\" content=\"it_IT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Validazione Statistica per Dispositivi Medici - Mathsly Research\" \/>\n<meta property=\"og:description\" content=\"Mathsly Research offre consulenza statistica specializzata per la validazione di dispositivi medici e IVD. 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