{"id":12930,"date":"2026-05-21T12:18:11","date_gmt":"2026-05-21T12:18:11","guid":{"rendered":"https:\/\/mdxcro.com\/ivd-cro-2\/"},"modified":"2026-08-07T16:46:30","modified_gmt":"2026-08-07T16:46:30","slug":"ivd-cro-2","status":"publish","type":"page","link":"https:\/\/mdxcro.com\/es\/ivd-cro-2\/","title":{"rendered":"CRO de diagn\u00f3stico 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  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.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=\"\/es\/wp-json\/wp\/v2\/pages\/12930\" data-token=\"36def11f97a67346439bbb8f916bcbe1\" data-token-time=\"1788167588\"><noscript class=\"wpforms-error-noscript\">Por favor, activa JavaScript en tu navegador para completar este formulario.<\/noscript><div id=\"wpforms-error-noscript\" style=\"display: none;\">Por favor, activa JavaScript en tu navegador para completar este formulario.<\/div><div 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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=\"Cargando\"><\/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  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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 ? 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La mayor\u00eda de los clientes comienzan con un servicio y ampl\u00edan el compromiso a medida que evoluciona el proyecto. <\/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\">Estrategia regulatoria y cumplimiento normativo<\/div>\n                        <div class=\"back\"><\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Validaci\u00f3n anal\u00edtica y cl\u00ednica<\/div>\n                        <div class=\"back\"><\/div>\n                    <\/div>\n                                    <div class=\"card card--background-black\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Redacci\u00f3n m\u00e9dica y preparaci\u00f3n de expedientes<\/div>\n                        <div class=\"back\"><\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Dise\u00f1o e implementaci\u00f3n de sistemas de gesti\u00f3n de calidad<\/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\">Vigilancia poscomercializaci\u00f3n y seguridad<\/div>\n                        <div class=\"back\"><\/div>\n                    <\/div>\n                                    <div class=\"card card--background-black\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Diagn\u00f3sticos complementarios, nuestra especializaci\u00f3n principal<\/div>\n                        <div class=\"back\"><\/div>\n                    <\/div>\n                            <\/div>\n        \n            <\/div>\n<\/section>\n<section id=\"block_72306d80e3f8100e0db336acff81e38d\" 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\">POR QU\u00c9 LOS FABRICANTES ELIGEN UNA CRO ESPECIALIZADA EN IVD<\/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 mayor\u00eda de los retrasos en proyectos de IVD son regulatorios, no cient\u00edficos.<\/h2><div class=\"description wysiwyg\"><p>Cuando un estudio no supera la revisi\u00f3n del Organismo Notificado o una presentaci\u00f3n requiere un redise\u00f1o completo, la causa rara vez es el dispositivo. Casi siempre se trata de una estrategia regulatoria que no se dise\u00f1\u00f3 para IVD desde el principio. <\/p>\n<h2>La clasificaci\u00f3n err\u00f3nea y las v\u00edas regulatorias incorrectas cuestan meses.<\/h2>\n<p>&nbsp;<\/p>\n<p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\">Una CRO generalista de dispositivos m\u00e9dicos aplica la l\u00f3gica del MDR a proyectos de IVD. Los marcos de clasificaci\u00f3n de riesgos son diferentes, los requisitos de evidencia son diferentes y las expectativas del Organismo Notificado son diferentes. Clasificar un diagn\u00f3stico complementario oncol\u00f3gico como Clase A cuando es Clase C significa redise\u00f1ar todo el expediente, normalmente un retraso de seis meses como m\u00ednimo. MDx CRO trabaja exclusivamente en IVD. Acertamos con la clasificaci\u00f3n desde el principio y dise\u00f1amos cada estudio y archivo t\u00e9cnico en torno a la v\u00eda regulatoria que realmente se aplicar\u00e1 a su 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\">El acceso a pacientes y muestras es el riesgo m\u00e1s subestimado en la planificaci\u00f3n de estudios de IVD.<\/h2><div class=\"description wysiwyg\"><p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\">Los d\u00e9ficits de reclutamiento, la disponibilidad insuficiente de muestras y los estudios con potencia estad\u00edstica insuficiente se encuentran entre las razones m\u00e1s comunes por las que los estudios de rendimiento cl\u00ednico de IVD no logran ofrecer resultados utilizables. Las consecuencias van m\u00e1s all\u00e1 del cronograma: un estudio con potencia insuficiente significa evidencia estad\u00edstica insuficiente para la presentaci\u00f3n regulatoria, lo que implica redise\u00f1o, nuevo estudio y costes significativos. MDx CRO anticipa las limitaciones de acceso en la fase de dise\u00f1o del protocolo. Combinamos rigor bioestad\u00edstico con experiencia operativa en centros cl\u00ednicos para construir estudios que sean real\u00edsticamente ejecutables y regulatoriamente s\u00f3lidos.   <\/p>\n<p>&nbsp;<\/p>\n<h2>La responsabilidad regulatoria no puede ser \u00fanicamente una carga interna.<\/h2>\n<p>&nbsp;<\/p>\n<p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\">Los responsables de asuntos regulatorios y equipos cl\u00ednicos en organizaciones fabricantes de IVD soportan una presi\u00f3n significativa por parte de la alta direcci\u00f3n en torno a los plazos de cumplimiento y los resultados de las presentaciones. El valor de una CRO especializada en IVD no es solo t\u00e9cnico, es la responsabilidad compartida de un resultado. MDx CRO act\u00faa como socio regulatorio, no como proveedor. Aportamos la orientaci\u00f3n estrat\u00e9gica, las relaciones con Organismos Notificados y la experiencia multidisciplinar (cient\u00edficos, especialistas en asuntos regulatorios, redactores m\u00e9dicos, profesionales de control de calidad y antiguos revisores de Organismos Notificados) para que su equipo no navegue solo por presentaciones complejas.   <\/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_ac5f5ff3d8c1bc624c0ea40a0bdc7566\" 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 de IVD frente a CRO generalista de dispositivos m\u00e9dicos<\/h2><div class=\"description wysiwyg\"><p>Muchos fabricantes cometen el error de contratar una CRO generalista para proyectos de IVD. Las CRO generalistas a menudo realizan pruebas excesivas, malinterpretan la clasificaci\u00f3n de riesgos, carecen de relaciones con Organismos Notificados y no coordinan adecuadamente los diagn\u00f3sticos complementarios. <\/p>\n<p>Un especialista en CRO de IVD como MDx comprende esta jerarqu\u00eda. Conocemos qu\u00e9 v\u00edas regulatorias se aplican a CDx oncol\u00f3gicos, pruebas moleculares e IVD generales. Clasificamos el riesgo correctamente a la primera. Dise\u00f1amos estudios de validaci\u00f3n que satisfacen a los Organismos Notificados sin realizar pruebas excesivas.   <\/p>\n<table style=\"height: 184px\" width=\"805\">\n<thead>\n<tr>\n<th>Aspecto<\/th>\n<th>CRO de IVD<\/th>\n<th>CRO generalista de dispositivos<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Enfoque regulatorio<\/td>\n<td>IVDR, MDR (diagn\u00f3sticos)<\/td>\n<td style=\"text-align: left\">MDR (dispositivos)<\/td>\n<\/tr>\n<tr>\n<td>Evidencia requerida<\/td>\n<td>Validez anal\u00edtica<\/td>\n<td>Rendimiento cl\u00ednico<\/td>\n<\/tr>\n<tr>\n<td>Plazo t\u00edpico<\/td>\n<td>12-18 meses (Clase B\/C)<\/td>\n<td>18-36 meses<\/td>\n<\/tr>\n<tr>\n<td>Experiencia de laboratorio<\/td>\n<td>Profunda (validaci\u00f3n anal\u00edtica)<\/td>\n<td>Limitada<\/td>\n<\/tr>\n<tr>\n<td>Diagn\u00f3sticos complementarios<\/td>\n<td>Experiencia en regulaci\u00f3n dual<\/td>\n<td>Experiencia limitada<\/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_5ff7566343316ced620efdecf7ead77e\" class=\"faqs\" style=\"\">\n    <div class=\"container\">\n    <div class=\"content\">\n      <div class=\"column\">\n                  <h2 class=\"headline\">Preguntas frecuentes sobre servicios de CRO de IVD<\/h2>\n                          <a class=\"button button--default\" href=\"https:\/\/mdxcro.com\/es\/contacto\/?utm_source=ivd_cro\" target=\"\">\n            Contacte con un experto en IVD           <\/a>\n              <\/div>\n      <div class=\"column\">\n                  <ul class=\"faq-list\">\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">\u00bfCu\u00e1l es la diferencia entre un IVD y un dispositivo m\u00e9dico?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>Un diagn\u00f3stico in vitro (IVD) es una prueba realizada sobre una muestra (sangre, tejido, orina) para detectar enfermedades, infecciones o afecciones gen\u00e9ticas. Un dispositivo m\u00e9dico se utiliza directamente sobre o en el cuerpo del paciente. Los IVD est\u00e1n regulados por el IVDR en Europa y normas espec\u00edficas de la FDA en EE. UU. Los dispositivos m\u00e9dicos est\u00e1n regulados por el MDR en Europa.   <\/p>\n<p>Los diagn\u00f3sticos complementarios son IVD que est\u00e1n corregulados con medicamentos farmac\u00e9uticos o biol\u00f3gicos. Por lo tanto, un CDx se enfrenta tanto a la regulaci\u00f3n de IVD COMO a la regulaci\u00f3n de medicamentos, raz\u00f3n por la cual la experiencia especializada es fundamental. <\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">\u00bfCu\u00e1l es el plazo m\u00e1s r\u00e1pido para la aprobaci\u00f3n IVDR?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>Los dispositivos IVDR de Clase A (bajo riesgo) pueden lograr la conformidad en 3-6 meses si la documentaci\u00f3n est\u00e1 completa. La Clase B suele tardar 12-18 meses. La Clase C\/D puede tardar 18-36+ meses.  <\/p>\n<p>En MDx, nuestro historial muestra plazos un 25-30 % m\u00e1s r\u00e1pidos que la media del sector, alrededor de 12-14 meses para Clase B, porque dise\u00f1amos expedientes para la aprobaci\u00f3n, no solo para el cumplimiento.<\/p>\n<p>Los plazos dependen de:<\/p>\n<ul>\n<li>Complejidad de la clasificaci\u00f3n de riesgos<\/li>\n<li>Calidad de su estrategia regulatoria inicial<\/li>\n<li>Disponibilidad de datos de validaci\u00f3n existentes<\/li>\n<li>Carga de trabajo y preferencias del Organismo Notificado<\/li>\n<li>Calidad de su respuesta a las consultas regulatorias<\/li>\n<\/ul>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">\u00bfNecesitamos apoyo de CRO de IVD para la presentaci\u00f3n ante la FDA?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>S\u00ed, especialmente si est\u00e1 desarrollando un diagn\u00f3stico complementario o un LDT de alto riesgo. El panorama regulatorio de la FDA para IVD es complejo y est\u00e1 en evoluci\u00f3n. Los diagn\u00f3sticos complementarios codesarrollados con medicamentos enfrentan una complejidad particular porque deben satisfacer tanto las normas de IVD de la FDA como los requisitos de aprobaci\u00f3n de medicamentos.  <\/p>\n<p>Ayudamos a las empresas biotecnol\u00f3gicas a coordinar presentaciones paralelas de manera eficiente para que ambas v\u00edas avancen juntas.<\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">\u00bfQu\u00e9 es EUDAMED y por qu\u00e9 es importante?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>EUDAMED es la base de datos europea donde debe registrarse toda la informaci\u00f3n de dispositivos IVDR. Es una base de datos p\u00fablica que contiene identificaci\u00f3n de dispositivos, informaci\u00f3n del fabricante, informaci\u00f3n del Organismo Notificado, res\u00famenes de vigilancia poscomercializaci\u00f3n, informes de incidentes graves y actualizaciones de rendimiento. <\/p>\n<p>El registro es obligatorio tras la aprobaci\u00f3n y debe mantenerse actualizado. Los reguladores supervisan activamente EUDAMED. El incumplimiento puede dar lugar a advertencias o medidas coercitivas.  <\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">\u00bfLos diagn\u00f3sticos complementarios est\u00e1n regulados de manera diferente a otros IVD?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>S\u00ed, significativamente. Un diagn\u00f3stico complementario (CDx) es un IVD que tiene una asociaci\u00f3n documentada con un medicamento o biol\u00f3gico espec\u00edfico. Los CDx enfrentan una regulaci\u00f3n dual:  <\/p>\n<ol>\n<li>IVDR (o normas de IVD de la FDA) como diagn\u00f3stico<\/li>\n<li>V\u00eda de aprobaci\u00f3n de medicamentos (EMA o FDA) como complemento terap\u00e9utico<\/li>\n<\/ol>\n<p>Esto significa que la validaci\u00f3n anal\u00edtica sirve para ambas presentaciones regulatorias, el rendimiento cl\u00ednico puede demostrarse mediante ensayos de medicamentos y la coordinaci\u00f3n de plazos entre los equipos de diagn\u00f3stico y medicamentos es fundamental.<\/p>\n<p>Aqu\u00ed es donde la experiencia especializada en CDx marca una gran diferencia. Coordinamos estas v\u00edas paralelas para que ambos equipos ganen. <\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">\u00bfCu\u00e1l es el error m\u00e1s com\u00fan que vemos en proyectos de IVD?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>El error m\u00e1s com\u00fan es clasificar err\u00f3neamente la categor\u00eda de riesgo del dispositivo. Los fabricantes a menudo subestiman la complejidad y clasifican como Clase A cuando en realidad es Clase B o C. Esto conduce a una estructura de expediente incorrecta, datos de validaci\u00f3n insuficientes, requisitos inesperados de participaci\u00f3n del Organismo Notificado y retrasos de m\u00e1s de 6 meses. <\/p>\n<p>Por eso nuestro primer paso es siempre una evaluaci\u00f3n rigurosa de riesgos. Acertamos con la clasificaci\u00f3n a la primera. <\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">\u00bfQu\u00e9 sucede tras la aprobaci\u00f3n? \u00bfSeguimos necesitando apoyo de CRO? <\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>S\u00ed. La vigilancia poscomercializaci\u00f3n es obligatoria y continua. Mientras que muchas CRO \u00abse retiran\u00bb tras la aprobaci\u00f3n, nosotros continuamos apoyando el registro en EUDAMED, la activaci\u00f3n del sistema de monitorizaci\u00f3n de eventos adversos, la planificaci\u00f3n de la monitorizaci\u00f3n del rendimiento, los informes peri\u00f3dicos de actualizaci\u00f3n de seguridad y el enlace regulatorio.  <\/p>\n<p>Considere la vigilancia poscomercializaci\u00f3n no como una idea tard\u00eda, sino como la base del \u00e9xito a largo plazo de su dispositivo en el mercado.<\/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\":\"\u00bfCu\u00e1l es la diferencia entre un IVD y un dispositivo m\u00e9dico?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Un diagn\u00f3stico in vitro (IVD) es una prueba realizada sobre una muestra (sangre, tejido, orina) para detectar enfermedades, infecciones o afecciones gen\u00e9ticas. Un dispositivo m\u00e9dico se utiliza directamente sobre o en el cuerpo del paciente. Los IVD est\u00e1n regulados por el IVDR en Europa y normas espec\u00edficas de la FDA en EE. UU. Los dispositivos m\u00e9dicos est\u00e1n regulados por el MDR en Europa.   \\nLos diagn\u00f3sticos complementarios son IVD que est\u00e1n corregulados con medicamentos farmac\u00e9uticos o biol\u00f3gicos. Por lo tanto, un CDx se enfrenta tanto a la regulaci\u00f3n de IVD COMO a la regulaci\u00f3n de medicamentos, raz\u00f3n por la cual la experiencia especializada es fundamental.\"}},{\"@type\":\"Question\",\"name\":\"\u00bfCu\u00e1l es el plazo m\u00e1s r\u00e1pido para la aprobaci\u00f3n IVDR?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Los dispositivos IVDR de Clase A (bajo riesgo) pueden lograr la conformidad en 3-6 meses si la documentaci\u00f3n est\u00e1 completa. La Clase B suele tardar 12-18 meses. La Clase C\/D puede tardar 18-36+ meses.  \\nEn MDx, nuestro historial muestra plazos un 25-30 % m\u00e1s r\u00e1pidos que la media del sector, alrededor de 12-14 meses para Clase B, porque dise\u00f1amos expedientes para la aprobaci\u00f3n, no solo para el cumplimiento.\\nLos plazos dependen de:\\n\\nComplejidad de la clasificaci\u00f3n de riesgos\\nCalidad de su estrategia regulatoria inicial\\nDisponibilidad de datos de validaci\u00f3n existentes\\nCarga de trabajo y preferencias del Organismo Notificado\\nCalidad de su respuesta a las consultas regulatorias\"}},{\"@type\":\"Question\",\"name\":\"\u00bfNecesitamos apoyo de CRO de IVD para la presentaci\u00f3n ante la FDA?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"S\u00ed, especialmente si est\u00e1 desarrollando un diagn\u00f3stico complementario o un LDT de alto riesgo. El panorama regulatorio de la FDA para IVD es complejo y est\u00e1 en evoluci\u00f3n. Los diagn\u00f3sticos complementarios codesarrollados con medicamentos enfrentan una complejidad particular porque deben satisfacer tanto las normas de IVD de la FDA como los requisitos de aprobaci\u00f3n de medicamentos.  \\nAyudamos a las empresas biotecnol\u00f3gicas a coordinar presentaciones paralelas de manera eficiente para que ambas v\u00edas avancen juntas.\"}},{\"@type\":\"Question\",\"name\":\"\u00bfQu\u00e9 es EUDAMED y por qu\u00e9 es importante?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"EUDAMED es la base de datos europea donde debe registrarse toda la informaci\u00f3n de dispositivos IVDR. Es una base de datos p\u00fablica que contiene identificaci\u00f3n de dispositivos, informaci\u00f3n del fabricante, informaci\u00f3n del Organismo Notificado, res\u00famenes de vigilancia poscomercializaci\u00f3n, informes de incidentes graves y actualizaciones de rendimiento. \\nEl registro es obligatorio tras la aprobaci\u00f3n y debe mantenerse actualizado. Los reguladores supervisan activamente EUDAMED. El incumplimiento puede dar lugar a advertencias o medidas coercitivas.\"}},{\"@type\":\"Question\",\"name\":\"\u00bfLos diagn\u00f3sticos complementarios est\u00e1n regulados de manera diferente a otros IVD?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"S\u00ed, significativamente. Un diagn\u00f3stico complementario (CDx) es un IVD que tiene una asociaci\u00f3n documentada con un medicamento o biol\u00f3gico espec\u00edfico. Los CDx enfrentan una regulaci\u00f3n dual:  \\n\\nIVDR (o normas de IVD de la FDA) como diagn\u00f3stico\\nV\u00eda de aprobaci\u00f3n de medicamentos (EMA o FDA) como complemento terap\u00e9utico\\n\\nEsto significa que la validaci\u00f3n anal\u00edtica sirve para ambas presentaciones regulatorias, el rendimiento cl\u00ednico puede demostrarse mediante ensayos de medicamentos y la coordinaci\u00f3n de plazos entre los equipos de diagn\u00f3stico y medicamentos es fundamental.\\nAqu\u00ed es donde la experiencia especializada en CDx marca una gran diferencia. Coordinamos estas v\u00edas paralelas para que ambos equipos ganen.\"}},{\"@type\":\"Question\",\"name\":\"\u00bfCu\u00e1l es el error m\u00e1s com\u00fan que vemos en proyectos de IVD?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"El error m\u00e1s com\u00fan es clasificar err\u00f3neamente la categor\u00eda de riesgo del dispositivo. Los fabricantes a menudo subestiman la complejidad y clasifican como Clase A cuando en realidad es Clase B o C. Esto conduce a una estructura de expediente incorrecta, datos de validaci\u00f3n insuficientes, requisitos inesperados de participaci\u00f3n del Organismo Notificado y retrasos de m\u00e1s de 6 meses. \\nPor eso nuestro primer paso es siempre una evaluaci\u00f3n rigurosa de riesgos. Acertamos con la clasificaci\u00f3n a la primera.\"}},{\"@type\":\"Question\",\"name\":\"\u00bfQu\u00e9 sucede tras la aprobaci\u00f3n? \u00bfSeguimos necesitando apoyo de CRO?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"S\u00ed. La vigilancia poscomercializaci\u00f3n es obligatoria y continua. 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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<\/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\/es\/contacto\/?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":12931,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-12930","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 de IVD global | Ensayos cl\u00ednicos y servicios regulatorios<\/title>\n<meta name=\"description\" content=\"Desde el concepto hasta la comercializaci\u00f3n, nuestra CRO de IVD proporciona investigaci\u00f3n por contrato, gesti\u00f3n de ensayos cl\u00ednicos y experiencia regulatoria para llevar sus diagn\u00f3sticos al mercado.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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