{"id":12531,"date":"2026-05-21T12:18:11","date_gmt":"2026-05-21T12:18:11","guid":{"rendered":"https:\/\/mdxcro.com\/ivd-cro\/"},"modified":"2026-08-26T13:57:27","modified_gmt":"2026-08-26T13:57:27","slug":"ivd-cro","status":"publish","type":"page","link":"https:\/\/mdxcro.com\/it\/ivd-cro\/","title":{"rendered":"CRO per Diagnostica In Vitro (IVD)"},"content":{"rendered":"\n<style>.mdx-ivd-hero {\n    --mdx-ivd-hero-blue: var(--color-blue, #0000F0);\n    --mdx-ivd-hero-white: var(--color-white, #FFFFFF);\n    --mdx-ivd-hero-black: var(--color-black, #000000);\n    position: relative;\n    isolation: isolate;\n    min-height: 720px;\n    padding-block: 80px 60px;\n    overflow: hidden;\n    background-color: var(--mdx-ivd-hero-black);\n    background-image:\n      linear-gradient(90deg, rgba(0, 0, 0, 0.82) 0%, rgba(0, 0, 0, 0.67) 58%, rgba(0, 0, 0, 0.42) 100%),\n      url(\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/04\/sectors-MDx-CRO-2.webp\");\n    background-position: center center;\n    background-repeat: no-repeat;\n    background-size: cover;\n    color: var(--mdx-ivd-hero-white);\n    font-family: var(--primary-font, \"Poppins\", sans-serif);\n  }\n\n  .mdx-ivd-hero,\n  .mdx-ivd-hero *,\n  .mdx-ivd-hero *::before,\n  .mdx-ivd-hero *::after {\n    box-sizing: border-box;\n  }\n\n  .mdx-ivd-hero .mdx-ivd-hero__container {\n    position: relative;\n    z-index: 1;\n    width: 100%;\n    max-width: calc(var(--container, 1320px) + 2 * var(--container-padding, 20px));\n    margin-inline: auto;\n    padding-inline: var(--container-padding, 20px);\n  }\n\n  .mdx-ivd-hero .mdx-ivd-hero__grid {\n    display: grid;\n    grid-template-columns: minmax(0, 1fr);\n    gap: 48px;\n    align-items: center;\n  }\n\n  .mdx-ivd-hero .mdx-ivd-hero__content,\n  .mdx-ivd-hero .mdx-ivd-hero__form-panel {\n    min-width: 0;\n  }\n\n  .mdx-ivd-hero .mdx-ivd-hero__eyebrow {\n    display: inline-flex;\n    align-items: center;\n    gap: 12px;\n    margin: 0 0 18px;\n    color: var(--mdx-ivd-hero-white);\n    font-size: 14px;\n    font-weight: 700;\n    line-height: 1.3;\n    letter-spacing: 0.08em;\n    text-transform: uppercase;\n  }\n\n  .mdx-ivd-hero .mdx-ivd-hero__eyebrow::before {\n    width: 34px;\n    height: 3px;\n    background: var(--mdx-ivd-hero-blue);\n    content: \"\";\n  }\n\n  .mdx-ivd-hero .mdx-ivd-hero__title {\n    max-width: 780px;\n    margin: 0;\n    color: var(--mdx-ivd-hero-white);\n    font-size: 40px;\n    font-weight: 700;\n    line-height: 1.12;\n    letter-spacing: -0.025em;\n  }\n\n  .mdx-ivd-hero .mdx-ivd-hero__copy {\n    max-width: 720px;\n    margin-top: 26px;\n  }\n\n  .mdx-ivd-hero .mdx-ivd-hero__lead,\n  .mdx-ivd-hero .mdx-ivd-hero__support {\n    margin: 0;\n    color: var(--mdx-ivd-hero-white);\n    font-size: 16px;\n    line-height: 1.6;\n  }\n\n  .mdx-ivd-hero .mdx-ivd-hero__lead {\n    font-weight: 600;\n  }\n\n  .mdx-ivd-hero .mdx-ivd-hero__support {\n    margin-top: 18px;\n    font-weight: 400;\n  }\n\n  .mdx-ivd-hero .mdx-ivd-hero__form-panel {\n    width: 100%;\n    max-width: 560px;\n    margin-inline: auto;\n    padding: 30px 24px;\n    border-radius: 0;\n    background: var(--mdx-ivd-hero-blue);\n    color: var(--mdx-ivd-hero-white);\n  }\n\n  .mdx-ivd-hero .mdx-ivd-hero__form-kicker {\n    margin: 0 0 10px;\n    color: var(--mdx-ivd-hero-white);\n    font-size: 13px;\n    font-weight: 700;\n    line-height: 1.3;\n    letter-spacing: 0.08em;\n    text-transform: uppercase;\n  }\n\n  .mdx-ivd-hero .mdx-ivd-hero__form-title {\n    margin: 0;\n    color: var(--mdx-ivd-hero-white);\n    font-size: 28px;\n    font-weight: 700;\n    line-height: 1.2;\n  }\n\n  .mdx-ivd-hero .mdx-ivd-hero__form-intro {\n    margin: 12px 0 24px;\n    color: var(--mdx-ivd-hero-white);\n    font-size: 15px;\n    line-height: 1.5;\n  }\n\n  .mdx-ivd-hero .mdx-ivd-hero__form-panel .wpforms-container {\n    margin: 0;\n  }\n\n  .mdx-ivd-hero .mdx-ivd-hero__form-panel .wpforms-field {\n    padding-block: 8px;\n 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.mdx-ivd-hero .mdx-ivd-hero__form-panel textarea {\n    min-height: 112px;\n    resize: vertical;\n  }\n\n  .mdx-ivd-hero .mdx-ivd-hero__form-panel input:focus,\n  .mdx-ivd-hero .mdx-ivd-hero__form-panel select:focus,\n  .mdx-ivd-hero .mdx-ivd-hero__form-panel textarea:focus {\n    border-color: var(--mdx-ivd-hero-white);\n    outline: 3px solid rgba(255, 255, 255, 0.45);\n    outline-offset: 2px;\n  }\n\n  .mdx-ivd-hero .mdx-ivd-hero__form-panel .wpforms-submit-container {\n    padding-top: 18px;\n  }\n\n  .mdx-ivd-hero .mdx-ivd-hero__form-panel button[type=\"submit\"] {\n    min-height: 50px;\n    padding: 10px 26px;\n    border: 2px solid var(--mdx-ivd-hero-white);\n    border-radius: 0;\n    background: var(--mdx-ivd-hero-white);\n    color: var(--mdx-ivd-hero-blue);\n    font-family: inherit;\n    font-size: 16px;\n    font-weight: 700;\n    line-height: 1.3;\n    cursor: pointer;\n    transition: background-color 160ms ease, color 160ms ease;\n  }\n\n  .mdx-ivd-hero .mdx-ivd-hero__form-panel button[type=\"submit\"]:hover,\n  .mdx-ivd-hero .mdx-ivd-hero__form-panel button[type=\"submit\"]:focus-visible {\n    background: var(--mdx-ivd-hero-black);\n    color: var(--mdx-ivd-hero-white);\n  }\n\n  .mdx-ivd-hero .mdx-ivd-hero__form-panel .wpforms-error,\n  .mdx-ivd-hero .mdx-ivd-hero__form-panel label.wpforms-error {\n    color: var(--mdx-ivd-hero-white);\n    font-weight: 600;\n  }\n\n  @media (min-width: 768px) {\n    .mdx-ivd-hero {\n      min-height: 760px;\n      padding-block: 100px 80px;\n    }\n\n    .mdx-ivd-hero .mdx-ivd-hero__grid {\n      grid-template-columns: minmax(0, 1.06fr) minmax(360px, 0.94fr);\n      gap: 54px;\n    }\n\n    .mdx-ivd-hero .mdx-ivd-hero__title {\n      font-size: 50px;\n    }\n\n    .mdx-ivd-hero .mdx-ivd-hero__lead,\n    .mdx-ivd-hero .mdx-ivd-hero__support {\n      font-size: 18px;\n    }\n\n    .mdx-ivd-hero .mdx-ivd-hero__form-panel {\n      padding: 40px;\n    }\n  }\n\n  @media (min-width: 1280px) {\n    .mdx-ivd-hero {\n      min-height: 820px;\n      padding-block: 120px 100px;\n    }\n\n    .mdx-ivd-hero .mdx-ivd-hero__grid {\n      grid-template-columns: minmax(0, 1.15fr) minmax(430px, 0.85fr);\n      gap: 80px;\n    }\n\n    .mdx-ivd-hero .mdx-ivd-hero__title {\n      font-size: 60px;\n    }\n\n    .mdx-ivd-hero .mdx-ivd-hero__form-panel {\n      padding: 46px;\n    }\n  }\n\n  @media (prefers-reduced-motion: reduce) {\n    .mdx-ivd-hero .mdx-ivd-hero__form-panel button[type=\"submit\"] {\n      transition: none;\n    }\n  }\n<\/style><section class=\"mdx-ivd-hero\" aria-labelledby=\"mdx-ivd-hero-title\"><div class=\"container mdx-ivd-hero__container\"><div class=\"mdx-ivd-hero__grid\"><div class=\"mdx-ivd-hero__content\"><h1 class=\"mdx-ivd-hero__title\" id=\"mdx-ivd-hero-title\">IVD CRO services built for the complexity of global regulatory submissions.<\/h1><div class=\"mdx-ivd-hero__copy\"><p class=\"mdx-ivd-hero__lead\"><strong>Clinical performance studies, regulatory strategy, and IVDR compliance, delivered by a team that understands IVD regulation as deeply as the science behind your device.<\/strong><\/p><p class=\"mdx-ivd-hero__support\">From companion diagnostics to NGS and molecular testing, we cover the full regulatory and clinical spectrum.<\/p><\/div><\/div><aside class=\"mdx-ivd-hero__form-panel\" aria-labelledby=\"mdx-ivd-hero-form-title\"><p class=\"mdx-ivd-hero__form-kicker\">Request a quotation<\/p><style id=\"wpforms-css-vars-6633\">\n\t\t\t\t#wpforms-6633 {\n\t\t\t\t--wpforms-field-size-input-height: 43px;\n--wpforms-field-size-input-spacing: 15px;\n--wpforms-field-size-font-size: 16px;\n--wpforms-field-size-line-height: 19px;\n--wpforms-field-size-padding-h: 14px;\n--wpforms-field-size-checkbox-size: 16px;\n--wpforms-field-size-sublabel-spacing: 5px;\n--wpforms-field-size-icon-size: 1;\n--wpforms-label-size-font-size: 16px;\n--wpforms-label-size-line-height: 19px;\n--wpforms-label-size-sublabel-font-size: 14px;\n--wpforms-label-size-sublabel-line-height: 17px;\n--wpforms-button-size-font-size: 17px;\n--wpforms-button-size-height: 41px;\n--wpforms-button-size-padding-h: 15px;\n--wpforms-button-size-margin-top: 10px;\n--wpforms-container-shadow-size-box-shadow: none;\n\t\t\t}\n\t\t\t<\/style><div class=\"wpforms-container wpforms-container-full mdx-contact-form wpforms-render-modern\" id=\"wpforms-6633\"><form id=\"wpforms-form-6633\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"6633\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/it\/wp-json\/wp\/v2\/pages\/12531\" data-token=\"36def11f97a67346439bbb8f916bcbe1\" data-token-time=\"1788167635\"><noscript class=\"wpforms-error-noscript\">Abilita JavaScript nel browser per completare questo modulo.<\/noscript><div id=\"wpforms-error-noscript\" style=\"display: none;\">Abilita JavaScript nel browser per completare questo modulo.<\/div><div class=\"wpforms-field-container\"><div 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aria-errormessage=\"wpforms-6633-field_3-error\" aria-describedby=\"wpforms-6633-field_3-description\" required><\/textarea><div id=\"wpforms-6633-field_3-description\" class=\"wpforms-field-description\">Include device type, current challenge, or regulatory stage.<\/div><\/div><div id=\"wpforms-6633-field_8-container\" class=\"wpforms-field wpforms-field-html\" data-field-type=\"html\" data-field-id=\"8\"><div id=\"wpforms-6633-field_8\" aria-errormessage=\"wpforms-6633-field_8-error\">Reach out directly if you do not have a business email <strong>contact@mdxcro.com<\/strong><br \/><br \/>We respect your privacy. All information submitted will \u2028remain confidential.<\/div><\/div><div id=\"wpforms-6633-field_9-container\" class=\"wpforms-field wpforms-field-checkbox\" data-field-type=\"checkbox\" data-field-id=\"9\"><fieldset><legend class=\"wpforms-field-label wpforms-label-hide\" aria-hidden=\"false\">Checkboxes <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/legend><ul id=\"wpforms-6633-field_9\" class=\"wpforms-field-required\"><li class=\"choice-1 depth-1\"><input type=\"checkbox\" id=\"wpforms-6633-field_9_1\" name=\"wpforms[fields][9][]\" value=\"I have read, comprehended, and agreed to the &lt;a href=&quot;\/privacy-policy\/&quot;&gt;Privacy&lt;\/a&gt; and &lt;a href=&quot;\/cookies-policy&quot;&gt;Cookies Policy&lt;\/a&gt;\" aria-errormessage=\"wpforms-6633-field_9_1-error\" required ><label class=\"wpforms-field-label-inline\" for=\"wpforms-6633-field_9_1\">I have read, comprehended, and agreed to the <a href=\"\/privacy-policy\/\">Privacy<\/a> and <a 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type=\"hidden\" name=\"page_url\" value=\"https:\/\/mdxcro.com\/it\/wp-json\/wp\/v2\/pages\/12531\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-6633\" class=\"wpforms-submit button button--secondary\" data-alt-text=\"Sending...\" data-submit-text=\"Submit Project\" aria-live=\"assertive\" value=\"wpforms-submit\">Submit Project<\/button><img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/plugins\/wpforms\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Caricamento\"><\/div><\/form><\/div>  <!-- .wpforms-container -->\n      <\/aside><\/div><\/div><\/section>\n\n<style>\n  .mdx-client-voices {\n\n    --mdx-client-voices-surface: var(--color-white, #FAFAFA);\n    --mdx-client-voices-text: #1A1A1A;\n    --mdx-client-voices-muted: #5F6368;\n    --mdx-client-voices-border: #E0E6ED;\n    --mdx-client-voices-blue: var(--color-blue, #0000F0);\n    position: relative;\n    display: flex;\n    min-height: 50vh;\n    align-items: center;\n    overflow: hidden;\n    padding-block: 56px;\n    background: var(--mdx-client-voices-bg);\n    color: var(--mdx-client-voices-text);\n    font-family: var(--primary-font, \"Poppins\", sans-serif);\n  }\n\n  .mdx-client-voices,\n  .mdx-client-voices *,\n  .mdx-client-voices *::before,\n  .mdx-client-voices *::after {\n    box-sizing: border-box;\n  }\n\n  .mdx-client-voices .mdx-client-voices__container {\n    position: relative;\n    width: 100%;\n    max-width: calc(var(--container, 1320px) + 2 * var(--container-padding, 20px));\n    margin-inline: auto;\n    padding-inline: var(--container-padding, 20px);\n  }\n\n  .mdx-client-voices .mdx-client-voices__header {\n    display: grid;\n    gap: 24px;\n    align-items: end;\n    margin-bottom: 40px;\n  }\n\n  .mdx-client-voices .mdx-client-voices__eyebrow {\n    margin: 0 0 10px;\n    color: var(--mdx-client-voices-blue);\n    font-size: 12px;\n    font-weight: 700;\n    letter-spacing: 0.08em;\n    line-height: 1.3;\n    text-transform: uppercase;\n  }\n\n  .mdx-client-voices .mdx-client-voices__title {\n    max-width: 720px;\n    margin: 0;\n    font-size: clamp(30px, 3.4vw, 46px);\n    font-weight: 700;\n    line-height: 1.14;\n  }\n\n  .mdx-client-voices .mdx-client-voices__title-highlight {\n    color: var(--mdx-client-voices-blue);\n  }\n\n  .mdx-client-voices .mdx-client-voices__score {\n    display: grid;\n    grid-template-columns: auto auto;\n    gap: 0 12px;\n    width: fit-content;\n    padding-left: 18px;\n    border-left: 4px solid var(--mdx-client-voices-blue);\n  }\n\n  .mdx-client-voices .mdx-client-voices__score-value {\n    grid-row: 1 \/ 3;\n    align-self: center;\n    color: var(--mdx-client-voices-blue);\n    font-size: 42px;\n    font-weight: 700;\n    line-height: 1;\n  }\n\n  .mdx-client-voices .mdx-client-voices__score-label {\n    align-self: end;\n    font-size: 14px;\n    font-weight: 700;\n    line-height: 1.2;\n  }\n\n  .mdx-client-voices .mdx-client-voices__score-source {\n    align-self: start;\n    color: var(--mdx-client-voices-muted);\n    font-size: 12px;\n    line-height: 1.4;\n  }\n\n  .mdx-client-voices .mdx-client-voices__body {\n    display: grid;\n    gap: 28px;\n    min-width: 0;\n  }\n\n  .mdx-client-voices .mdx-client-voices__intro {\n    display: grid;\n    grid-template-columns: 1fr auto;\n    gap: 16px 24px;\n    align-items: end;\n  }\n\n  .mdx-client-voices .mdx-client-voices__quote-mark {\n    grid-column: 1 \/ -1;\n    width: 52px;\n    height: 36px;\n    color: var(--mdx-client-voices-blue);\n  }\n\n  .mdx-client-voices .mdx-client-voices__intro-title {\n    max-width: 240px;\n    margin: 0;\n    font-size: 22px;\n    font-weight: 600;\n    line-height: 1.25;\n  }\n\n  .mdx-client-voices .mdx-client-voices__controls {\n    display: flex;\n    gap: 8px;\n  }\n\n  .mdx-client-voices .mdx-client-voices__control {\n    display: inline-grid;\n    width: 46px;\n    height: 46px;\n    place-items: center;\n    padding: 0;\n    border: 1px solid var(--mdx-client-voices-blue);\n    border-radius: 0;\n    background: transparent;\n    color: var(--mdx-client-voices-blue);\n    cursor: pointer;\n  }\n\n  .mdx-client-voices .mdx-client-voices__control:hover,\n  .mdx-client-voices .mdx-client-voices__control:focus-visible {\n    background: var(--mdx-client-voices-blue);\n    color: #FFFFFF;\n  }\n\n  .mdx-client-voices .mdx-client-voices__control:focus-visible,\n  .mdx-client-voices .mdx-client-voices__card:focus-visible {\n    outline: 3px solid #1A1A1A;\n    outline-offset: 3px;\n  }\n\n  .mdx-client-voices .mdx-client-voices__control:disabled {\n    border-color: #A9B1BA;\n    color: #777777;\n    cursor: not-allowed;\n    opacity: 0.65;\n  }\n\n  .mdx-client-voices .mdx-client-voices__rail {\n    display: grid;\n    grid-auto-columns: minmax(260px, 86%);\n    grid-auto-flow: column;\n    gap: 16px;\n    min-width: 0;\n    overflow-x: auto;\n    overscroll-behavior-inline: contain;\n    padding: 4px 4px 18px;\n    scroll-padding-inline: 4px;\n    scroll-snap-type: inline mandatory;\n    scrollbar-color: var(--mdx-client-voices-blue) var(--mdx-client-voices-border);\n    scrollbar-width: thin;\n  }\n\n  .mdx-client-voices .mdx-client-voices__card {\n    display: flex;\n    min-width: 0;\n    min-height: 320px;\n    flex-direction: column;\n    padding: 26px;\n    border: 1px solid var(--mdx-client-voices-border);\n    border-radius: 0;\n    background: var(--mdx-client-voices-surface);\n    color: var(--mdx-client-voices-text);\n    scroll-snap-align: start;\n    transition: background-color 180ms ease, border-color 180ms ease, color 180ms ease;\n  }\n\n  .mdx-client-voices .mdx-client-voices__card.is-active {\n    border-color: var(--mdx-client-voices-blue);\n    background: var(--mdx-client-voices-blue);\n    color: #FFFFFF;\n  }\n\n  .mdx-client-voices .mdx-client-voices__rating {\n    display: flex;\n    flex-wrap: wrap;\n    gap: 10px;\n    align-items: center;\n    margin-bottom: 22px;\n    color: var(--mdx-client-voices-blue);\n  }\n\n  .mdx-client-voices .mdx-client-voices__card.is-active .mdx-client-voices__rating {\n    color: #FFFFFF;\n  }\n\n  .mdx-client-voices .mdx-client-voices__stars {\n    font-size: 16px;\n    letter-spacing: 0.08em;\n    line-height: 1;\n  }\n\n  .mdx-client-voices .mdx-client-voices__rating-number {\n    font-size: 15px;\n    font-weight: 700;\n    line-height: 1;\n  }\n\n  .mdx-client-voices .mdx-client-voices__review {\n    margin: 0;\n    font-size: 15px;\n    line-height: 1.65;\n  }\n\n  .mdx-client-voices .mdx-client-voices__attribution {\n    margin-top: auto;\n    padding-top: 24px;\n    border-top: 1px solid var(--mdx-client-voices-border);\n  }\n\n  .mdx-client-voices .mdx-client-voices__card.is-active .mdx-client-voices__attribution {\n    border-top-color: rgba(255, 255, 255, 0.45);\n  }\n\n  .mdx-client-voices .mdx-client-voices__role,\n  .mdx-client-voices .mdx-client-voices__company {\n    display: block;\n  }\n\n  .mdx-client-voices .mdx-client-voices__role {\n    font-size: 13px;\n    font-weight: 700;\n    line-height: 1.35;\n  }\n\n  .mdx-client-voices .mdx-client-voices__company {\n    margin-top: 4px;\n    color: var(--mdx-client-voices-muted);\n    font-size: 12px;\n    line-height: 1.4;\n  }\n\n  .mdx-client-voices .mdx-client-voices__card.is-active .mdx-client-voices__company {\n    color: rgba(255, 255, 255, 0.82);\n  }\n\n  .mdx-client-voices .mdx-client-voices__adapted-note {\n    display: block;\n    margin-top: 10px;\n    color: var(--mdx-client-voices-muted);\n    font-size: 10px;\n    line-height: 1.4;\n  }\n\n  .mdx-client-voices .mdx-client-voices__card.is-active .mdx-client-voices__adapted-note {\n    color: rgba(255, 255, 255, 0.74);\n  }\n\n  .mdx-client-voices .mdx-client-voices__sr-only {\n    position: absolute;\n    width: 1px;\n    height: 1px;\n    padding: 0;\n    overflow: hidden;\n    clip: rect(0, 0, 0, 0);\n    white-space: nowrap;\n    border: 0;\n  }\n\n  @media (min-width: 768px) {\n    .mdx-client-voices {\n      padding-block: 64px;\n    }\n\n    .mdx-client-voices .mdx-client-voices__header {\n      grid-template-columns: minmax(0, 1fr) auto;\n      gap: 48px;\n      margin-bottom: 48px;\n    }\n\n    .mdx-client-voices .mdx-client-voices__body {\n      grid-template-columns: 220px minmax(0, 1fr);\n      gap: 28px;\n      align-items: stretch;\n    }\n\n    .mdx-client-voices .mdx-client-voices__intro {\n      display: flex;\n      align-items: flex-start;\n      flex-direction: column;\n      padding-block: 16px 22px;\n    }\n\n    .mdx-client-voices .mdx-client-voices__controls {\n      margin-top: auto;\n    }\n\n    .mdx-client-voices .mdx-client-voices__rail {\n      grid-auto-columns: minmax(280px, calc((100% - 16px) \/ 2));\n    }\n  }\n\n  @media (min-width: 1280px) {\n    .mdx-client-voices {\n      padding-block: 72px;\n    }\n\n    .mdx-client-voices .mdx-client-voices__body {\n      grid-template-columns: 250px minmax(0, 1fr);\n      gap: 36px;\n    }\n\n    .mdx-client-voices .mdx-client-voices__rail {\n      grid-auto-columns: minmax(280px, calc((100% - 32px) \/ 3));\n    }\n\n    .mdx-client-voices .mdx-client-voices__card {\n      min-height: 340px;\n      padding: 28px;\n    }\n  }\n\n  @media (prefers-reduced-motion: reduce) {\n    .mdx-client-voices .mdx-client-voices__card {\n      transition: none;\n    }\n  }\n<\/style>\n\n<section class=\"mdx-client-voices\" data-mdx-component=\"client-voices\" aria-label=\"Client testimonials\">\n  <div class=\"container mdx-client-voices__container\">\n    <div class=\"mdx-client-voices__header\">\n      <div>\n      \n        <h2 class=\"mdx-client-voices__title\">\n          Trusted expertise. <span class=\"mdx-client-voices__title-highlight\">Confident decisions.<\/span>\n        <\/h2>\n      <\/div>\n\n      <div class=\"mdx-client-voices__score\" aria-label=\"NPS score plus 9, based on 159 client survey responses\">\n        <strong class=\"mdx-client-voices__score-value\">+9<\/strong>\n        <span class=\"mdx-client-voices__score-label\">NPS<\/span>\n        <span class=\"mdx-client-voices__score-source\">Based on 159 client survey responses<\/span>\n      <\/div>\n    <\/div>\n\n    <div class=\"mdx-client-voices__body\">\n      <div class=\"mdx-client-voices__intro\">\n        <svg class=\"mdx-client-voices__quote-mark\" viewbox=\"0 0 52 36\" aria-hidden=\"true\">\n          <path fill=\"currentColor\" d=\"M0 36V21.2C0 7.8 6.4 1 19.2 0v8.1c-5.6.7-8.7 3.7-9.1 8.9H20v19H0Zm31.8 0V21.2C31.8 7.8 38.2 1 51 0v8.1c-5.6.7-8.7 3.7-9.1 8.9H52v19H31.8Z\"><\/path>\n        <\/svg>\n        <h3 class=\"mdx-client-voices__intro-title\">What our clients say<\/h3>\n        <div class=\"mdx-client-voices__controls\" aria-label=\"Testimonial controls\">\n          <button class=\"mdx-client-voices__control mdx-client-voices__control--prev\" type=\"button\" aria-label=\"Previous testimonial\">\n            <svg width=\"20\" height=\"20\" viewbox=\"0 0 20 20\" aria-hidden=\"true\"><path d=\"m12.5 4.5-5.5 5.5 5.5 5.5M7.5 10h8\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"1.8\" stroke-linecap=\"square\" stroke-linejoin=\"miter\"><\/path><\/svg>\n          <\/button>\n          <button class=\"mdx-client-voices__control mdx-client-voices__control--next\" type=\"button\" aria-label=\"Next testimonial\">\n            <svg width=\"20\" height=\"20\" viewbox=\"0 0 20 20\" aria-hidden=\"true\"><path d=\"m7.5 4.5 5.5 5.5-5.5 5.5M12.5 10h-8\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"1.8\" stroke-linecap=\"square\" stroke-linejoin=\"miter\"><\/path><\/svg>\n          <\/button>\n        <\/div>\n      <\/div>\n\n      <div class=\"mdx-client-voices__rail\" tabindex=\"0\" aria-label=\"Client testimonials. Swipe or use the previous and next buttons to explore.\">\n        <article class=\"mdx-client-voices__card\" tabindex=\"0\" data-review-card=\"\">\n          <div class=\"mdx-client-voices__rating\">\n            <span class=\"mdx-client-voices__stars\" aria-hidden=\"true\">\u2605\u2605\u2605\u2605\u2605<\/span>\n            <span class=\"mdx-client-voices__rating-number\">10\/10<\/span>\n            <span class=\"mdx-client-voices__sr-only\">Rating: 10 out of 10<\/span>\n          <\/div>\n          <p class=\"mdx-client-voices__review\">The IVDR training was excellently prepared and tailored to our needs. Its practical, interactive format answered our questions clearly and brought the whole team up to date.<\/p>\n          <footer class=\"mdx-client-voices__attribution\">\n            <span class=\"mdx-client-voices__role\">VP Regulatory Affairs<\/span>\n            <span class=\"mdx-client-voices__company\">Vivet Therapeutics<\/span>\n          \n          <\/footer>\n        <\/article>\n\n        <article class=\"mdx-client-voices__card is-active\" tabindex=\"0\" data-review-card=\"\" aria-current=\"true\">\n          <div class=\"mdx-client-voices__rating\">\n            <span class=\"mdx-client-voices__stars\" aria-hidden=\"true\">\u2605\u2605\u2605\u2605\u2605<\/span>\n            <span class=\"mdx-client-voices__rating-number\">10\/10<\/span>\n            <span class=\"mdx-client-voices__sr-only\">Rating: 10 out of 10<\/span>\n          <\/div>\n          <p class=\"mdx-client-voices__review\">MDx supported us promptly and went beyond expectations with its advice. We learned a great deal about IVDR, clinical studies and performance evaluation, and would gladly work with the team again.<\/p>\n          <footer class=\"mdx-client-voices__attribution\">\n            <span class=\"mdx-client-voices__role\">Client<\/span>\n            <span class=\"mdx-client-voices__company\">IVD company<\/span>\n           \n          <\/footer>\n        <\/article>\n\n        <article class=\"mdx-client-voices__card\" tabindex=\"0\" data-review-card=\"\">\n          <div class=\"mdx-client-voices__rating\">\n            <span class=\"mdx-client-voices__stars\" aria-hidden=\"true\">\u2605\u2605\u2605\u2605\u2605<\/span>\n            <span class=\"mdx-client-voices__rating-number\">10\/10<\/span>\n            <span class=\"mdx-client-voices__sr-only\">Rating: 10 out of 10<\/span>\n          <\/div>\n          <p class=\"mdx-client-voices__review\">The project was completed on time and to a high standard. We were very pleased with the results and would work with MDx again without hesitation.<\/p>\n          <footer class=\"mdx-client-voices__attribution\">\n            <span class=\"mdx-client-voices__role\">Client<\/span>\n            <span class=\"mdx-client-voices__company\">Regulatory consultancy<\/span>\n          \n          <\/footer>\n        <\/article>\n\n        <article class=\"mdx-client-voices__card\" tabindex=\"0\" data-review-card=\"\">\n          <div class=\"mdx-client-voices__rating\">\n            <span class=\"mdx-client-voices__stars\" aria-hidden=\"true\">\u2605\u2605\u2605\u2605\u2605<\/span>\n            <span class=\"mdx-client-voices__rating-number\">10\/10<\/span>\n            <span class=\"mdx-client-voices__sr-only\">Rating: 10 out of 10<\/span>\n          <\/div>\n          <p class=\"mdx-client-voices__review\">MDx has been a pleasure to work with: very professional and knowledgeable about the subject matter.<\/p>\n          <footer class=\"mdx-client-voices__attribution\">\n            <span class=\"mdx-client-voices__role\">Quality Assurance Professional<\/span>\n            <span class=\"mdx-client-voices__company\">Fulgent<\/span>\n         \n          <\/footer>\n        <\/article>\n\n        <article class=\"mdx-client-voices__card\" tabindex=\"0\" data-review-card=\"\">\n          <div class=\"mdx-client-voices__rating\">\n            <span class=\"mdx-client-voices__stars\" aria-hidden=\"true\">\u2605\u2605\u2605\u2605\u2606<\/span>\n            <span class=\"mdx-client-voices__rating-number\">8\/10<\/span>\n            <span class=\"mdx-client-voices__sr-only\">Rating: 8 out of 10<\/span>\n          <\/div>\n          <p class=\"mdx-client-voices__review\">We are generally very happy with the service received so far.<\/p>\n          <footer class=\"mdx-client-voices__attribution\">\n            <span class=\"mdx-client-voices__role\">Client<\/span>\n            <span class=\"mdx-client-voices__company\">Prolight Diagnostics<\/span>\n            \n          <\/footer>\n        <\/article>\n      <\/div>\n    <\/div>\n  <\/div>\n<\/section>\n\n<script>\n  (() => {\n    const roots = document.querySelectorAll('[data-mdx-component=\"client-voices\"]');\n\n    roots.forEach((root) => {\n      if (root.dataset.mdxInitialised === 'true') return;\n      root.dataset.mdxInitialised = 'true';\n\n      const rail = root.querySelector('.mdx-client-voices__rail');\n      const cards = Array.from(root.querySelectorAll('[data-review-card]'));\n      const previous = root.querySelector('.mdx-client-voices__control--prev');\n      const next = root.querySelector('.mdx-client-voices__control--next');\n      const reduceMotion = window.matchMedia('(prefers-reduced-motion: reduce)').matches;\n      let activeIndex = Math.max(0, cards.findIndex((card) => card.classList.contains('is-active')));\n      let scrollFrame = null;\n\n      if (!rail || !cards.length || !previous || !next) return;\n\n      const updateState = (index, moveRail = false) => {\n        activeIndex = Math.max(0, Math.min(index, cards.length - 1));\n\n        cards.forEach((card, cardIndex) => {\n          const isActive = cardIndex === activeIndex;\n          card.classList.toggle('is-active', isActive);\n          if (isActive) {\n            card.setAttribute('aria-current', 'true');\n          } else {\n            card.removeAttribute('aria-current');\n          }\n        });\n\n        previous.disabled = activeIndex === 0;\n        next.disabled = activeIndex === cards.length - 1;\n\n        if (moveRail) {\n          const targetLeft = rail.scrollLeft\n            + cards[activeIndex].getBoundingClientRect().left\n            - rail.getBoundingClientRect().left;\n\n          rail.scrollTo({\n            left: targetLeft,\n            behavior: reduceMotion ? 'auto' : 'smooth'\n          });\n        }\n      };\n\n      const selectNearestCard = () => {\n        const railLeft = rail.getBoundingClientRect().left;\n        let nearestIndex = 0;\n        let nearestDistance = Infinity;\n\n        cards.forEach((card, index) => {\n          const distance = Math.abs(card.getBoundingClientRect().left - railLeft);\n          if (distance < nearestDistance) {\n            nearestDistance = distance;\n            nearestIndex = index;\n          }\n        });\n\n        updateState(nearestIndex);\n      };\n\n      previous.addEventListener('click', () => updateState(activeIndex - 1, true));\n      next.addEventListener('click', () => updateState(activeIndex + 1, true));\n\n      cards.forEach((card, index) => {\n        card.addEventListener('click', () => updateState(index, true));\n        card.addEventListener('keydown', (event) => {\n          if (event.key === 'Enter' || event.key === ' ') {\n            event.preventDefault();\n            updateState(index, true);\n          }\n        });\n      });\n\n      rail.addEventListener('scroll', () => {\n        if (scrollFrame) cancelAnimationFrame(scrollFrame);\n        scrollFrame = requestAnimationFrame(selectNearestCard);\n      }, { passive: true });\n\n      updateState(activeIndex);\n    });\n  })();\n<\/script>\n\n<section class=\"key-stats\"  style=\"\">\n    <div class=\"container\">\n          <div class=\"headline\">CRO IVD leader in Europa <\/div>\n    \n    <div class=\"main-wrapper\">\n              <div class=\"box-grid\">\n                                    <div class=\"box\">\n                                  <div class=\"value\">100+  <\/div>\n                                                  <div class=\"legend\">Studi Analitici<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">9.4\/10<\/div>\n                                                  <div class=\"legend\">Soddisfazione del Cliente<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">+500<\/div>\n                                                  <div class=\"legend\">Dispositivi Immessi sul Mercato<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">90-95%  <\/div>\n                                                  <div class=\"legend\">approvazione alla prima submission<\/div>\n                              <\/div>\n                              <\/div>\n      \n          <\/div>\n\n    <div class=\"data\">\n      \n          <\/div>\n  <\/div>\n<\/section>\n\n<section id=\"block_48673b2db590d1ebb3525e56cd5421ae\" class=\"flip-cards flip-cards--three-columns flip-cards--card-size-small \" style=\"padding-top: var(--wp--preset--spacing--small); padding-bottom: var(--wp--preset--spacing--small); \">\n            <div class=\"container\">\n        <div class=\"content\">\n            \n                            <h2 class=\"title\">SERVIZI CRO IVD A SPETTRO COMPLETO<\/h2>\n            \n                            <div class=\"teaser wysiwyg\"><p>Un unico partner per l&#8217;intero ciclo di vita regolatorio e clinico IVD.<\/p>\n<\/div>\n            \n                            <div class=\"description wysiwyg\"><p><small>Dal mapping regolatorio iniziale alla sorveglianza post-market, MDx CRO copre ogni fase dello sviluppo e approvazione IVD. La maggior parte dei clienti inizia con un servizio ed espande l&#8217;engagement man mano che il progetto evolve. <\/small><\/p>\n<\/div>\n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <div class=\"card card--has-bg-image\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/Quality-Regulatory-Affairs-MDX-CRO-RA-Technical-Documentation.webp&#039;);\"                         >\n                        \n                                                                            \n                        <div class=\"front\">Strategia Regolatoria e Conformit\u00e0<\/div>\n                        <div class=\"back\"><\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Validazione Analitica e Clinica<\/div>\n                        <div class=\"back\"><\/div>\n                    <\/div>\n                                    <div class=\"card card--background-black\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Medical Writing e Preparazione Dossier<\/div>\n                        <div class=\"back\"><\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Progettazione e Implementazione Sistema di Gestione della Qualit\u00e0<\/div>\n                        <div class=\"back\"><\/div>\n                    <\/div>\n                                    <div class=\"card card--has-bg-image\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/Quality-Regulatory-Affairs-MDX-CRO-Scientific-Validity-Reports.webp&#039;);\"                         >\n                        \n                                                                            \n                        <div class=\"front\">Sorveglianza Post-Market e Sicurezza<\/div>\n                        <div class=\"back\"><\/div>\n                    <\/div>\n                                    <div class=\"card card--background-black\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Diagnostica Companion, la Nostra Specializzazione Core<\/div>\n                        <div class=\"back\"><\/div>\n                    <\/div>\n                            <\/div>\n        \n            <\/div>\n<\/section>\n<section id=\"block_11c52b8472dd4b81fffd72ada242c2e3\" class=\"text-image-wrapper\" style=\"padding-top: var(--wp--preset--spacing--medium); padding-bottom: var(--wp--preset--spacing--medium); \">\n    <div class=\"container\">\n                <div class=\"headline\">PERCH\u00c9 I PRODUTTORI SCELGONO UNA CRO IVD SPECIALIZZATA<\/div>\n                <div class=\"grid-wrapper\">\n            <section class=\"text-image\">\n                <div class=\"container\">\n                    <div class=\"grid\">\n                        <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">La maggior parte dei ritardi nei progetti IVD \u00e8 di natura regolatoria, non scientifica.<\/h2><div class=\"description wysiwyg\"><p>Quando uno studio non supera la revisione dell&#8217;Organismo Notificato o una submission richiede una riprogettazione completa, la causa \u00e8 raramente il dispositivo. \u00c8 quasi sempre una strategia regolatoria che non \u00e8 stata costruita per IVD fin dall&#8217;inizio. <\/p>\n<h2>Classificazione errata e percorsi regolatori non corretti costano mesi.<\/h2>\n<p>&nbsp;<\/p>\n<p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\">Una CRO generalista per dispositivi medici applica la logica MDR ai progetti IVD. I framework di classificazione del rischio sono diversi, i requisiti di evidenza sono diversi e le aspettative degli Organismi Notificati sono diverse. Classificare una diagnostica companion oncologica come Classe A quando \u00e8 Classe C significa riprogettare l&#8217;intero dossier \u2014 tipicamente un ritardo di sei mesi, minimo. MDx CRO lavora esclusivamente in IVD. Otteniamo la classificazione corretta fin dall&#8217;inizio e progettiamo ogni studio e fascicolo tecnico attorno al percorso regolatorio che si applicher\u00e0 effettivamente al tuo dispositivo.    <\/p>\n<\/div><\/div><\/div>                        <div class=\"column column--image\"><\/div>                    <\/div>\n                <\/div>\n            <\/section>\n            <section class=\"text-image\">\n                <div class=\"container\">\n                    <div class=\"grid\">\n                        <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">L&#8217;accesso a pazienti e campioni \u00e8 il rischio pi\u00f9 sottovalutato nella pianificazione degli studi IVD.<\/h2><div class=\"description wysiwyg\"><p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\">Carenze di arruolamento, disponibilit\u00e0 insufficiente di campioni e studi sottodimensionati sono tra le ragioni pi\u00f9 comuni per cui gli studi di performance clinica IVD non riescono a fornire risultati utilizzabili. Le conseguenze vanno oltre la timeline: uno studio sottodimensionato significa evidenza statistica insufficiente per la submission regolatoria, il che significa riprogettazione, nuovo studio e costi significativi. MDx CRO anticipa i vincoli di accesso nella fase di progettazione del protocollo. Combiniamo rigore biostatistico con esperienza operativa presso siti clinici per costruire studi realisticamente eseguibili e regolatorialmente solidi.   <\/p>\n<p>&nbsp;<\/p>\n<h2>La responsabilit\u00e0 regolatoria non pu\u00f2 essere solo un onere interno.<\/h2>\n<p>&nbsp;<\/p>\n<p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\">I responsabili degli affari regolatori e i team clinici nelle organizzazioni produttrici di IVD subiscono pressioni significative dal senior management riguardo alle tempistiche di conformit\u00e0 e agli esiti delle submission. Il valore di una CRO IVD specializzata non \u00e8 solo tecnico, \u00e8 la responsabilit\u00e0 condivisa per un risultato. MDx CRO agisce come partner regolatorio, non come fornitore. Portiamo la guida strategica, le relazioni con gli Organismi Notificati e l&#8217;expertise multidisciplinare, scienziati, specialisti di affari regolatori, medical writer, professionisti QA ed ex revisori di Organismi Notificati \u2014 cos\u00ec il tuo team non naviga da solo submission complesse.   <\/p>\n<\/div><\/div><\/div>                        <div class=\"column column--image\"><\/div>                    <\/div>\n                <\/div>\n            <\/section>\n        <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_250e6d0e57e903de08915e8c03e86ca0\" class=\"text-image text-image--reverse\" style=\"\">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">CRO IVD vs. CRO Generalista per Dispositivi Medici<\/h2><div class=\"description wysiwyg\"><p>Molti produttori commettono l&#8217;errore di assumere una CRO generalista per progetti IVD. Le CRO generaliste spesso testano eccessivamente, fraintendono la classificazione del rischio, mancano di relazioni con gli Organismi Notificati e non coordinano correttamente la diagnostica companion. <\/p>\n<p>Uno specialista CRO IVD come MDx comprende questa gerarchia. Sappiamo quali percorsi regolatori si applicano a CDx oncologica, test molecolari e IVD generali. Classifichiamo il rischio correttamente la prima volta. Progettiamo studi di validazione che soddisfano gli Organismi Notificati senza test eccessivi.   <\/p>\n<table style=\"height: 184px\" width=\"805\">\n<thead>\n<tr>\n<th>Aspetto<\/th>\n<th>CRO IVD<\/th>\n<th>CRO Generalista<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Focus Regolatorio<\/td>\n<td>IVDR, MDR (diagnostica)<\/td>\n<td style=\"text-align: left\">MDR (dispositivi)<\/td>\n<\/tr>\n<tr>\n<td>Evidenza Richiesta<\/td>\n<td>Validit\u00e0 analitica<\/td>\n<td>Performance clinica<\/td>\n<\/tr>\n<tr>\n<td>Timeline Tipica<\/td>\n<td>12\u201318 mesi (Classe B\/C)<\/td>\n<td>18\u201336 mesi<\/td>\n<\/tr>\n<tr>\n<td>Expertise di Laboratorio<\/td>\n<td>Approfondita (validazione analitica)<\/td>\n<td>Limitata<\/td>\n<\/tr>\n<tr>\n<td>Diagnostica Companion<\/td>\n<td>Expertise in doppia regolamentazione<\/td>\n<td>Esperienza limitata<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/clinical-research-lab-tool-MDx-CRO.webp\" alt=\"Advanced medical research microscope used in clinical studies to accelerate MedTech innovations and improve healthcare solutions.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n<section id=\"block_1728a8ffa2758470cca8fb724b5449d3\" class=\"faqs\" style=\"\">\n    <div class=\"container\">\n    <div class=\"content\">\n      <div class=\"column\">\n                  <h2 class=\"headline\">Domande Frequenti sui Servizi CRO IVD<\/h2>\n                          <a class=\"button button--default\" href=\"https:\/\/mdxcro.com\/it\/contatti\/?utm_source=ivd_cro\" target=\"\">\n            Contatta un esperto in IVD           <\/a>\n              <\/div>\n      <div class=\"column\">\n                  <ul class=\"faq-list\">\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Qual \u00e8 la differenza tra un IVD e un dispositivo medico?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>Un Diagnostico In Vitro (IVD) \u00e8 un test eseguito su un campione (sangue, tessuto, urina) per rilevare malattie, infezioni o condizioni genetiche. Un dispositivo medico viene utilizzato direttamente sul o nel corpo del paziente. Gli IVD sono regolamentati dall&#8217;IVDR in Europa e da regole FDA specifiche negli USA. I dispositivi medici sono regolamentati dall&#8217;MDR in Europa.   <\/p>\n<p>La diagnostica companion sono IVD co-regolamentati con farmaci o biologici. Quindi una CDx affronta sia la regolamentazione IVD CHE quella farmaceutica, motivo per cui l&#8217;expertise specializzata \u00e8 critica. <\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Qual \u00e8 la timeline pi\u00f9 rapida per l&#039;approvazione IVDR?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>R: I dispositivi IVDR Classe A (basso rischio) possono ottenere la conformit\u00e0 in 3-6 mesi se la documentazione \u00e8 completa. La Classe B richiede tipicamente 12-18 mesi. La Classe C\/D pu\u00f2 richiedere 18-36+ mesi.  <\/p>\n<p>In MDx, il nostro track record mostra timeline del 25-30% pi\u00f9 veloci rispetto alla media del settore, circa 12-14 mesi per Classe B, perch\u00e9 progettiamo dossier per l&#8217;approvazione, non solo per la conformit\u00e0.<\/p>\n<p>Le timeline sono determinate da:<\/p>\n<ul>\n<li>Complessit\u00e0 della classificazione del rischio<\/li>\n<li>Qualit\u00e0 della tua strategia regolatoria iniziale<\/li>\n<li>Disponibilit\u00e0 di dati di validazione esistenti<\/li>\n<li>Carico di lavoro e preferenze dell&#8217;Organismo Notificato<\/li>\n<li>Quanto bene rispondi alle richieste regolatorie<\/li>\n<\/ul>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Abbiamo bisogno del supporto di una CRO IVD per la submission FDA?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>S\u00ec, specialmente se stai sviluppando una diagnostica companion o un LDT ad alto rischio. Il panorama regolatorio FDA per gli IVD \u00e8 complesso e in evoluzione. La diagnostica companion co-sviluppata con farmaci affronta una complessit\u00e0 particolare perch\u00e9 deve soddisfare sia le regole FDA per IVD che i requisiti di approvazione farmaceutica.  <\/p>\n<p>Aiutiamo le aziende biotech a coordinare submission parallele in modo efficiente cos\u00ec entrambi i percorsi avanzano insieme.<\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Cos&#039;\u00e8 EUDAMED e perch\u00e9 \u00e8 importante?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>EUDAMED \u00e8 il database europeo dove devono essere registrate tutte le informazioni sui dispositivi IVDR. \u00c8 un database pubblico contenente identificazione del dispositivo, informazioni sul produttore, informazioni sull&#8217;Organismo Notificato, riepiloghi di sorveglianza post-market, rapporti di incidenti gravi e aggiornamenti sulle performance. <\/p>\n<p>La registrazione \u00e8 obbligatoria post-approvazione e deve essere mantenuta aggiornata. Le autorit\u00e0 regolatorie monitorano attivamente EUDAMED. La non conformit\u00e0 pu\u00f2 portare a avvertimenti o azioni di enforcement.  <\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">La diagnostica companion \u00e8 regolamentata diversamente dagli altri IVD?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>R: S\u00ec, in modo significativo. Una diagnostica companion (CDx) \u00e8 un IVD che ha un&#8217;associazione documentata con un farmaco o biologico specifico. Le CDx affrontano una doppia regolamentazione:  <\/p>\n<ol>\n<li>IVDR (o regole FDA IVD) come diagnostica<\/li>\n<li>Percorso di approvazione farmaceutica (EMA o FDA) come companion terapeutico<\/li>\n<\/ol>\n<p>Questo significa che la validazione analitica serve entrambe le submission regolatorie, la performance clinica pu\u00f2 essere dimostrata attraverso studi farmaceutici e il coordinamento delle timeline tra team diagnostico e farmaceutico \u00e8 critico.<\/p>\n<p>\u00c8 qui che l&#8217;expertise specializzata in CDx fa un&#8217;enorme differenza. Coordiniamo questi percorsi paralleli cos\u00ec entrambi i team vincono. <\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Qual \u00e8 l&#039;errore pi\u00f9 comune che vediamo nei progetti IVD?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>L&#8217;errore pi\u00f9 comune \u00e8 classificare erroneamente la categoria di rischio del dispositivo. I produttori spesso sottovalutano la complessit\u00e0 e classificano come Classe A quando \u00e8 realmente Classe B o C. Questo porta a struttura del dossier errata, dati di validazione insufficienti, requisiti imprevisti di coinvolgimento dell&#8217;Organismo Notificato e ritardi di oltre 6 mesi. <\/p>\n<p>Ecco perch\u00e9 il nostro primo passo \u00e8 sempre una valutazione rigorosa del rischio. Otteniamo la classificazione corretta la prima volta. <\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Cosa succede post-approvazione? Abbiamo ancora bisogno del supporto CRO? <\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>S\u00ec. La sorveglianza post-market \u00e8 obbligatoria e continua. Mentre molte CRO &#8220;consegnano&#8221; all&#8217;approvazione, noi continuiamo a supportare registrazione EUDAMED, attivazione sistema di monitoraggio eventi avversi, pianificazione monitoraggio performance, rapporti periodici di aggiornamento sulla sicurezza e liaison regolatoria.  <\/p>\n<p>Considera la PMS non come un ripensamento, ma come il fondamento per il successo di mercato a lungo termine del tuo dispositivo.<\/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\":\"Qual \u00e8 la differenza tra un IVD e un dispositivo medico?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Un Diagnostico In Vitro (IVD) \u00e8 un test eseguito su un campione (sangue, tessuto, urina) per rilevare malattie, infezioni o condizioni genetiche. Un dispositivo medico viene utilizzato direttamente sul o nel corpo del paziente. Gli IVD sono regolamentati dall&#8217;IVDR in Europa e da regole FDA specifiche negli USA. I dispositivi medici sono regolamentati dall&#8217;MDR in Europa.   \\nLa diagnostica companion sono IVD co-regolamentati con farmaci o biologici. Quindi una CDx affronta sia la regolamentazione IVD CHE quella farmaceutica, motivo per cui l&#8217;expertise specializzata \u00e8 critica.\"}},{\"@type\":\"Question\",\"name\":\"Qual \u00e8 la timeline pi\u00f9 rapida per l'approvazione IVDR?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"R: I dispositivi IVDR Classe A (basso rischio) possono ottenere la conformit\u00e0 in 3-6 mesi se la documentazione \u00e8 completa. La Classe B richiede tipicamente 12-18 mesi. La Classe C\/D pu\u00f2 richiedere 18-36+ mesi.  \\nIn MDx, il nostro track record mostra timeline del 25-30% pi\u00f9 veloci rispetto alla media del settore, circa 12-14 mesi per Classe B, perch\u00e9 progettiamo dossier per l&#8217;approvazione, non solo per la conformit\u00e0.\\nLe timeline sono determinate da:\\n\\nComplessit\u00e0 della classificazione del rischio\\nQualit\u00e0 della tua strategia regolatoria iniziale\\nDisponibilit\u00e0 di dati di validazione esistenti\\nCarico di lavoro e preferenze dell&#8217;Organismo Notificato\\nQuanto bene rispondi alle richieste regolatorie\"}},{\"@type\":\"Question\",\"name\":\"Abbiamo bisogno del supporto di una CRO IVD per la submission FDA?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"S\u00ec, specialmente se stai sviluppando una diagnostica companion o un LDT ad alto rischio. Il panorama regolatorio FDA per gli IVD \u00e8 complesso e in evoluzione. La diagnostica companion co-sviluppata con farmaci affronta una complessit\u00e0 particolare perch\u00e9 deve soddisfare sia le regole FDA per IVD che i requisiti di approvazione farmaceutica.  \\nAiutiamo le aziende biotech a coordinare submission parallele in modo efficiente cos\u00ec entrambi i percorsi avanzano insieme.\"}},{\"@type\":\"Question\",\"name\":\"Cos'\u00e8 EUDAMED e perch\u00e9 \u00e8 importante?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"EUDAMED \u00e8 il database europeo dove devono essere registrate tutte le informazioni sui dispositivi IVDR. \u00c8 un database pubblico contenente identificazione del dispositivo, informazioni sul produttore, informazioni sull&#8217;Organismo Notificato, riepiloghi di sorveglianza post-market, rapporti di incidenti gravi e aggiornamenti sulle performance. \\nLa registrazione \u00e8 obbligatoria post-approvazione e deve essere mantenuta aggiornata. Le autorit\u00e0 regolatorie monitorano attivamente EUDAMED. La non conformit\u00e0 pu\u00f2 portare a avvertimenti o azioni di enforcement.\"}},{\"@type\":\"Question\",\"name\":\"La diagnostica companion \u00e8 regolamentata diversamente dagli altri IVD?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"R: S\u00ec, in modo significativo. Una diagnostica companion (CDx) \u00e8 un IVD che ha un&#8217;associazione documentata con un farmaco o biologico specifico. Le CDx affrontano una doppia regolamentazione:  \\n\\nIVDR (o regole FDA IVD) come diagnostica\\nPercorso di approvazione farmaceutica (EMA o FDA) come companion terapeutico\\n\\nQuesto significa che la validazione analitica serve entrambe le submission regolatorie, la performance clinica pu\u00f2 essere dimostrata attraverso studi farmaceutici e il coordinamento delle timeline tra team diagnostico e farmaceutico \u00e8 critico.\\n\u00c8 qui che l&#8217;expertise specializzata in CDx fa un&#8217;enorme differenza. Coordiniamo questi percorsi paralleli cos\u00ec entrambi i team vincono.\"}},{\"@type\":\"Question\",\"name\":\"Qual \u00e8 l'errore pi\u00f9 comune che vediamo nei progetti IVD?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"L&#8217;errore pi\u00f9 comune \u00e8 classificare erroneamente la categoria di rischio del dispositivo. I produttori spesso sottovalutano la complessit\u00e0 e classificano come Classe A quando \u00e8 realmente Classe B o C. Questo porta a struttura del dossier errata, dati di validazione insufficienti, requisiti imprevisti di coinvolgimento dell&#8217;Organismo Notificato e ritardi di oltre 6 mesi. \\nEcco perch\u00e9 il nostro primo passo \u00e8 sempre una valutazione rigorosa del rischio. Otteniamo la classificazione corretta la prima volta.\"}},{\"@type\":\"Question\",\"name\":\"Cosa succede post-approvazione? Abbiamo ancora bisogno del supporto CRO?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"S\u00ec. La sorveglianza post-market \u00e8 obbligatoria e continua. Mentre molte CRO &#8220;consegnano&#8221; all&#8217;approvazione, noi continuiamo a supportare registrazione EUDAMED, attivazione sistema di monitoraggio eventi avversi, pianificazione monitoraggio performance, rapporti periodici di aggiornamento sulla sicurezza e liaison regolatoria.  \\nConsidera la PMS non come un ripensamento, ma come il fondamento per il successo di mercato a lungo termine del tuo dispositivo.\"}}]}  <\/script>\n\n<style>.mdx-ep {\n  background: #FFFFFF;\n  width: 100%;\n  padding: 80px 0;\n  min-height: 70vh;\n  display: flex;\n  align-items: center;\n}\n\n.mdx-ep__inner {\n  max-width: var(--container, 1320px);\n  width: 100%;\n  margin: 0 auto;\n  padding-inline: var(--container-padding, 20px);\n}\n\n@media (min-width: 768px) {\n  .mdx-ep__inner {\n    padding-inline: var(--container-padding, 60px);\n  }\n}\n\n.mdx-ep__eyebrow {\n  font-size: 11px !important;\n  line-height: 1.4 !important;\n  font-weight: 600 !important;\n  letter-spacing: 0.1em !important;\n  text-transform: uppercase !important;\n  color: #0000F0 !important;\n  margin: 0 0 12px !important;\n  padding: 0 !important;\n}\n\n.mdx-ep__heading {\n  color: #1A1A1A;\n  margin: 0 0 40px !important;\n  padding: 0 !important;\n}\n\n.mdx-ep__cols {\n  display: grid;\n  grid-template-columns: 200px 1fr;\n  gap: 56px;\n  align-items: start;\n}\n\n\/* AUTHOR COLUMN *\/\n.mdx-ep__author-col {\n  display: flex;\n  flex-direction: column;\n  align-items: center;\n  text-align: center;\n}\n\n.mdx-ep__img-wrap {\n  width: 120px;\n  height: 120px;\n  border-radius: 50%;\n  overflow: hidden;\n  margin: 0 0 16px;\n  flex-shrink: 0;\n}\n\n.mdx-ep__img-wrap img {\n  width: 120px;\n  height: 120px;\n  object-fit: cover;\n  display: block;\n}\n\n.mdx-ep__name {\n  font-weight: 600 !important;\n  color: #1A1A1A !important;\n  margin: 0 0 4px !important;\n  padding: 0 !important;\n}\n\n.mdx-ep__role {\n  color: #444444 !important;\n  margin: 0 !important;\n  padding: 0 !important;\n}\n\n\/* TEXT COLUMN \u2014 hereda via .wysiwyg *\/\n.mdx-ep__text-col {\n  min-width: 0;\n}\n\n\/* Pull-quote: solo borde izquierdo cobalt *\/\n.mdx-ep__pullquote {\n  border-left: 3px solid #0000F0;\n  padding-left: 20px !important;\n  margin: 28px 0 !important;\n}\n\n.mdx-ep__pullquote p {\n  font-weight: 600 !important;\n}\n\n\/* WP AUTHOR oculto para SEO *\/\n.mdx-ep__wp-author {\n  position: absolute;\n  width: 1px;\n  height: 1px;\n  overflow: hidden;\n  clip: rect(0 0 0 0);\n  white-space: nowrap;\n}\n\n\/* MOBILE *\/\n@media (max-width: 768px) {\n  .mdx-ep {\n    min-height: auto;\n    padding: 56px 0;\n    align-items: flex-start;\n  }\n  .mdx-ep__cols {\n    grid-template-columns: 1fr;\n    gap: 28px;\n  }\n  .mdx-ep__author-col {\n    flex-direction: row;\n    text-align: left;\n    align-items: center;\n    gap: 20px;\n  }\n  .mdx-ep__img-wrap {\n    width: 80px;\n    height: 80px;\n    min-width: 80px;\n    margin: 0;\n  }\n  .mdx-ep__img-wrap img {\n    width: 80px;\n    height: 80px;\n  }\n  .mdx-ep__author-text {\n    text-align: left;\n  }\n}\n<\/style><!-- WP Author block oculto \u2014 WordPress lo procesa para SEO\/schema --><div class=\"mdx-ep__wp-author wp-block-post-author\" aria-hidden=\"true\"><div class=\"wp-block-post-author__avatar\"><img decoding=\"async\" alt=\"Professional woman in business attire representing MedTech innovation and leadership at MDX.\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/03\/Catarina-Sepulveda-Team-MDx-CRO-48x48.webp\" srcset=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/03\/Catarina-Sepulveda-Team-MDx-CRO-96x96.webp 2x\" class=\"avatar avatar-48 photo\" height=\"48\" width=\"48\"\/><\/div><div class=\"wp-block-post-author__content\"><p class=\"wp-block-post-author__name\">Catarina Sep\u00falveda<\/p><\/div><\/div><!-- Bloque editorial visible --><section class=\"mdx-ep\"><div class=\"mdx-ep__inner\"><div class=\"mdx-ep__cols\"><!-- Columna autor --><div class=\"mdx-ep__author-col\"><div class=\"mdx-ep__img-wrap\"><img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/03\/Catarina-Sepulveda-Team-MDx-CRO-96x96.webp\" alt=\"Catarina Sep\u00falveda, IVD Director\" width=\"120\" height=\"120\"\/><\/div><div class=\"mdx-ep__author-text\"><p class=\"mdx-ep__name\">Catarina Sep\u00falveda<\/p><p class=\"mdx-ep__role\">IVD Director<\/p><\/div><\/div><!-- Columna texto \u2014 .wysiwyg hereda font-size, line-height y margin de p del tema --><div class=\"mdx-ep__text-col wysiwyg\"><p>One question MDx CRO hears consistently from new clients is some version of: do you actually understand my device and its regulatory path? It is a fair question. The IVD regulatory landscape, particularly post-IVDR, has become significantly more demanding, and the cost of working with a partner who does not fully understand it is measured in months and in redesigned submissions.<\/p><p>Catarina Sep\u00falveda, IVD Director at MDx CRO, has spent her career at the intersection of IVD science and regulatory strategy.<\/p><div class=\"mdx-ep__pullquote\"><p>The role of a specialist IVD CRO is not simply to execute studies, but to act as a regulatory translator, converting the complexity of IVDR, FDA requirements, and Notified Body expectations into a clear, executable strategy for the manufacturer.<\/p><\/div><p>What clients are really looking for, as Catarina describes it, is regulatory confidence. Not just a passed submission, but the assurance that the strategy behind it was sound: that the claim wording is defensible, that the study design will hold up to scrutiny, and that if a Notified Body raises a question, there is an expert in the room who has seen that question before and knows how to answer it.<\/p><p>She also points to something less discussed in the industry: the value of predictability. Involving a specialist IVD CRO does not always mean a faster timeline. It means a more predictable one. Manufacturers can make better business decisions when they have a realistic, evidence-based view of what the regulatory path will require and how long it will take. That clarity, she notes, is itself a form of risk reduction.<\/p><\/div><\/div><\/div><\/section>\n\n\n\n\n<meta charset=\"UTF-8\"\/><meta name=\"viewport\" content=\"width=device-width, initial-scale=1.0\"\/><title>MDx IVD CTA Section<\/title><link rel=\"preconnect\" href=\"https:\/\/fonts.googleapis.com\"\/><link rel=\"preconnect\" href=\"https:\/\/fonts.gstatic.com\" crossorigin=\"\"\/><link href=\"https:\/\/fonts.googleapis.com\/css2?family=Poppins:wght@400;600;700&#038;display=swap\" rel=\"stylesheet\"\/><style>\/* \u2500\u2500 MDx Site Tokens \u2014 from \/mnt\/project\/index.css \u2500\u2500 *\/\n  :root {\n    --mdx-font:         \"Poppins\", \"sans-serif\";\n    --container:        1320px;\n    --container-pad:    60px;\n    --color-black:      #000000;\n    --color-white:      #FFFFFF;\n    --color-frost:      #F3F8FB;\n    --color-blue:       #0000F0;\n    --color-blue-dark:  #0000DA;\n    --color-carbon:     #1A1A1A;\n    --color-page-bg:    #FAFAFA;\n    --color-text:       #111111;\n    --color-text-sec:   #444444;\n  }\n\n  *, *::before, *::after { box-sizing: border-box; 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}\n\n  \/* eyebrow label \u2014 11px\/600 fixed, from MDx label pattern *\/\n  .cta-label {\n    display: inline-block;\n    font-family: var(--mdx-font);\n    font-size: 11px;\n    font-weight: 600;\n    letter-spacing: 0.10em;\n    text-transform: uppercase;\n    color: var(--color-blue);\n    margin-bottom: 20px;\n  }\n\n  \/* H2 \u2014 from .call-to-action .title in index.css *\/\n  .cta-h2 {\n    font-family: var(--mdx-font);\n    font-size: 30px;   \/* mobile base \u2014 matches dev CSS *\/\n    font-weight: 700;\n    line-height: 1.3;\n    color: var(--color-black);\n    margin-bottom: 24px;\n  }\n  .cta-h2 em {\n    font-style: normal;\n    color: var(--color-blue);\n  }\n\n  \/* Body \u2014 from .call-to-action .description in index.css *\/\n  .cta-body {\n    font-family: var(--mdx-font);\n    font-size: 16px;   \/* mobile base \u2014 matches dev CSS *\/\n    font-weight: 400;\n    line-height: 1.3;\n    color: var(--color-text-sec);\n    max-width: 640px;\n  }\n  .cta-body p + p { margin-top: 16px; 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}\n  }\n<\/style><section class=\"cta-section\" aria-label=\"IVD Consultation CTA\"><div class=\"cta-bg\" role=\"presentation\" aria-hidden=\"true\"><\/div><div class=\"cta-inner\"><div class=\"cta-left\"><h2 class=\"cta-h2\">Ready to Launch Your<br\/>IVD on <em>IVDR?<\/em><\/h2><div class=\"cta-body\"><p>Our IVD CRO team has guided 35+ biotech and pharma companies from concept to market approval. Whether you&#8217;re developing an oncology companion diagnostic, laboratory-developed test, or precision medicine IVD, we understand the regulatory landscape and can accelerate your path to compliance.<\/p><p>We specialise in what other CROs miss: the intersection of clinical expertise, analytical validation, regulatory intelligence, and Notified Body relationships that turns complex IVD projects into successful launches.<\/p><\/div><\/div><div class=\"cta-services\" aria-label=\"IVD services offered\"><span class=\"cta-service-item\">Companion Diagnostics<\/span><span class=\"cta-service-item\">Analytical Validation<\/span><span class=\"cta-service-item\">Clinical Evidence<\/span><span class=\"cta-service-item\">IVDR Regulatory Strategy<\/span><span class=\"cta-service-item\">Team of Former NB<\/span><\/div><\/div><div class=\"cta-bottom-bar\"><div class=\"cta-bottom-bar__inner\"><p class=\"cta-bottom-bar__question\">Got an IVD project in need of regulatory assessment?\n      <\/p><a href=\"https:\/\/mdxcro.com\/it\/contatto\/?utm_source=IVD_cro\" class=\"mdx-btn\" rel=\"noopener\">Schedule an IVD Consultation\n      <\/a><\/div><\/div><\/section>\n","protected":false},"excerpt":{"rendered":"<p>IVD CRO services built for the complexity of global regulatory submissions. Clinical performance studies, regulatory strategy, and IVDR compliance, delivered by a team that understands IVD regulation as deeply as the science behind your device. From companion diagnostics to NGS and molecular testing, we cover the full regulatory and clinical spectrum. Request a quotation Trusted [&hellip;]<\/p>\n","protected":false},"author":13,"featured_media":12533,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-12531","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CRO IVD Globale | Studi Clinici e Servizi Regolatori<\/title>\n<meta name=\"description\" content=\"Dal concept alla commercializzazione, la nostra CRO IVD fornisce ricerca contrattuale, gestione di studi clinici ed expertise regolatoria per portare la tua diagnostica sul mercato.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mdxcro.com\/it\/ivd-cro\/\" \/>\n<meta property=\"og:locale\" content=\"it_IT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CRO IVD Globale | Studi Clinici e Servizi Regolatori\" \/>\n<meta property=\"og:description\" content=\"Dal concept alla commercializzazione, la nostra CRO IVD fornisce ricerca contrattuale, gestione di studi clinici ed expertise regolatoria per portare la tua diagnostica sul mercato.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/mdxcro.com\/it\/ivd-cro\/\" \/>\n<meta property=\"og:site_name\" content=\"MDx CRO\" \/>\n<meta property=\"article:modified_time\" content=\"2026-08-26T13:57:27+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/05\/ivd-cro-mdxcro-medtech.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1672\" \/>\n\t<meta property=\"og:image:height\" content=\"941\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Tempo di lettura stimato\" \/>\n\t<meta name=\"twitter:data1\" content=\"3 minuti\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/it\\\/ivd-cro\\\/\",\"url\":\"https:\\\/\\\/mdxcro.com\\\/it\\\/ivd-cro\\\/\",\"name\":\"CRO IVD Globale | Studi Clinici e Servizi Regolatori\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/it\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/it\\\/ivd-cro\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/it\\\/ivd-cro\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mdxcro.com\\\/wp-content\\\/uploads\\\/2026\\\/05\\\/ivd-cro-mdxcro-medtech.webp\",\"datePublished\":\"2026-05-21T12:18:11+00:00\",\"dateModified\":\"2026-08-26T13:57:27+00:00\",\"description\":\"Dal concept alla commercializzazione, la nostra CRO IVD fornisce ricerca contrattuale, gestione di studi clinici ed expertise regolatoria per portare la tua diagnostica sul mercato.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/it\\\/ivd-cro\\\/#breadcrumb\"},\"inLanguage\":\"it-IT\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/mdxcro.com\\\/it\\\/ivd-cro\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"it-IT\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/it\\\/ivd-cro\\\/#primaryimage\",\"url\":\"https:\\\/\\\/mdxcro.com\\\/wp-content\\\/uploads\\\/2026\\\/05\\\/ivd-cro-mdxcro-medtech.webp\",\"contentUrl\":\"https:\\\/\\\/mdxcro.com\\\/wp-content\\\/uploads\\\/2026\\\/05\\\/ivd-cro-mdxcro-medtech.webp\",\"width\":1672,\"height\":941,\"caption\":\"Vista dettagliata di una cellula staminale in ambiente di laboratorio, che evidenzia membrana cellulare, citoplasma e mezzo circostante utilizzato nelle terapie rigenerative avanzate.\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/it\\\/ivd-cro\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/mdxcro.com\\\/it\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"CRO per Diagnostica In Vitro (IVD)\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/it\\\/#website\",\"url\":\"https:\\\/\\\/mdxcro.com\\\/it\\\/\",\"name\":\"MDx CRO\",\"description\":\"MedTech &amp; 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