{"id":11401,"date":"2026-03-25T10:26:12","date_gmt":"2026-03-25T10:26:12","guid":{"rendered":"https:\/\/mdxcro.com\/medical-device-cro\/"},"modified":"2026-08-07T16:59:01","modified_gmt":"2026-08-07T16:59:01","slug":"organisme-de-recherche-clinique-specialise-dans-les-dispositifs-medicaux","status":"publish","type":"page","link":"https:\/\/mdxcro.com\/fr\/organisme-de-recherche-clinique-specialise-dans-les-dispositifs-medicaux\/","title":{"rendered":"CRO pour dispositifs m\u00e9dicaux"},"content":{"rendered":"\n<section id=\"block_ae59e9c2b775d4101f16ffa84544625d\" class=\"hero hero--with-form\" style=\"padding-top: var(--wp--preset--spacing--medium); padding-bottom: var(--wp--preset--spacing--medium);\">\n    <div class=\"hero--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/Medical-Device-CRO-MDx-CRO.webp\" fetchpriority=\"high\" class=\"no-lazy\" alt=\"\" \/>\n    <\/div>\n        <div class=\"container\">\n                <div class=\"hero__grid\">\n            <div class=\"hero__content-col\">\n                <div class=\"content\">\n                                    <h1 class=\"title\">Solutions r\u00e9glementaires et CRO pour dispositifs m\u00e9dicaux full-service<\/h1>\n            \n                            <div class=\"description\"><p>De la conception de l\u2019\u00e9tude \u00e0 la certification MDR, votre partenaire CRO europ\u00e9en d\u00e9di\u00e9 aux investigations cliniques de dispositifs m\u00e9dicaux. Dirig\u00e9e par d\u2019anciens \u00e9valuateurs d\u2019organismes notifi\u00e9s, avec plus de 50 \u00e9tudes de dispositifs dans plus de 20 pays. <\/p>\n<\/div>\n            \n                                    <\/div>\n            <\/div>\n            <div class=\"hero__form-col mdx-form-wrapper\">\n                <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=\"\/fr\/wp-json\/wp\/v2\/pages\/11401\" data-token=\"8a8f2de8ac823dc29a4e0a3911d16da1\" data-token-time=\"1789152470\"><noscript class=\"wpforms-error-noscript\">Veuillez activer JavaScript dans votre navigateur pour remplir ce formulaire.<\/noscript><div id=\"wpforms-error-noscript\" style=\"display: none;\">Veuillez activer JavaScript dans votre navigateur pour remplir ce formulaire.<\/div><div class=\"wpforms-field-container\"><div id=\"wpforms-6633-field_20-container\" class=\"wpforms-field wpforms-field-name\" data-field-type=\"name\" 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for=\"wpforms-6633-field_20-last\" class=\"wpforms-field-sublabel after wpforms-sublabel-hide\">Nom<\/label><\/div><\/div><\/fieldset><\/div>\t\t<div id=\"wpforms-6633-field_1-container\"\n\t\t\tclass=\"wpforms-field wpforms-field-text\"\n\t\t\tdata-field-type=\"text\"\n\t\t\tdata-field-id=\"1\"\n\t\t\t>\n\t\t\t<label class=\"wpforms-field-label\" for=\"wpforms-6633-field_1\" >Company Checkboxes URL<\/label>\n\t\t\t<input type=\"text\" id=\"wpforms-6633-field_1\" class=\"wpforms-field-medium\" name=\"wpforms[fields][1]\" >\n\t\t<\/div>\n\t\t<div id=\"wpforms-6633-field_2-container\" class=\"wpforms-field wpforms-field-email contact-business-email\" data-field-type=\"email\" data-field-id=\"2\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6633-field_2\" aria-hidden=\"false\">Business Email <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"email\" id=\"wpforms-6633-field_2\" class=\"wpforms-field-large 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for=\"wpforms-6633-field_3\" aria-hidden=\"false\">Project Description <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><textarea id=\"wpforms-6633-field_3\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][3]\" placeholder=\"Project Description\" 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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data-field-id=\"11\"><input type=\"hidden\" id=\"wpforms-6633-field_11\" name=\"wpforms[fields][11]\"><\/div><div id=\"wpforms-6633-field_12-container\" class=\"wpforms-field wpforms-field-hidden mdx-utm_campaign\" data-field-type=\"hidden\" data-field-id=\"12\"><input type=\"hidden\" id=\"wpforms-6633-field_12\" name=\"wpforms[fields][12]\"><\/div><div id=\"wpforms-6633-field_15-container\" class=\"wpforms-field wpforms-field-hidden mdx-utm_term\" data-field-type=\"hidden\" data-field-id=\"15\"><input type=\"hidden\" id=\"wpforms-6633-field_15\" name=\"wpforms[fields][15]\"><\/div><div id=\"wpforms-6633-field_21-container\" class=\"wpforms-field wpforms-field-hidden mdx-utm_content\" data-field-type=\"hidden\" data-field-id=\"21\"><input type=\"hidden\" id=\"wpforms-6633-field_21\" name=\"wpforms[fields][21]\"><\/div><div id=\"wpforms-6633-field_30-container\" class=\"wpforms-field wpforms-field-hidden mdx-gclid\" data-field-type=\"hidden\" data-field-id=\"30\"><input type=\"hidden\" id=\"wpforms-6633-field_30\" name=\"wpforms[fields][30]\"><\/div><div id=\"wpforms-6633-field_31-container\" class=\"wpforms-field wpforms-field-hidden mdx-tracking_status\" data-field-type=\"hidden\" data-field-id=\"31\"><input type=\"hidden\" id=\"wpforms-6633-field_31\" name=\"wpforms[fields][31]\"><\/div><div id=\"wpforms-6633-field_32-container\" class=\"wpforms-field wpforms-field-hidden mdx-first_url\" data-field-type=\"hidden\" data-field-id=\"32\"><input type=\"hidden\" id=\"wpforms-6633-field_32\" name=\"wpforms[fields][32]\"><\/div><div id=\"wpforms-6633-field_33-container\" class=\"wpforms-field wpforms-field-hidden\" data-field-type=\"hidden\" data-field-id=\"33\"><input type=\"hidden\" id=\"wpforms-6633-field_33\" name=\"wpforms[fields][33]\" value=\"contact_form\"><\/div><script>\n\t\t\t\t( function() {\n\t\t\t\t\tconst style = document.createElement( 'style' );\n\t\t\t\t\tstyle.appendChild( document.createTextNode( '#wpforms-6633-field_1-container { position: absolute !important; overflow: hidden !important; display: inline !important; height: 1px !important; width: 1px !important; z-index: -1000 !important; padding: 0 !important; } #wpforms-6633-field_1-container input { visibility: hidden; } #wpforms-conversational-form-page #wpforms-6633-field_1-container label { counter-increment: none; }' ) );\n\t\t\t\t\tdocument.head.appendChild( style );\n\t\t\t\t\tdocument.currentScript?.remove();\n\t\t\t\t} )();\n\t\t\t<\/script><\/div><!-- .wpforms-field-container --><div class=\"wpforms-recaptcha-container wpforms-is-recaptcha wpforms-is-recaptcha-type-v3\" ><input type=\"hidden\" name=\"wpforms[recaptcha]\" value=\"\"><\/div><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"6633\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/mdxcro.com\/fr\/wp-json\/wp\/v2\/pages\/11401\"><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=\"Chargement en cours\"><\/div><\/form><\/div>  <!-- .wpforms-container -->            <\/div>\n        <\/div>\n            <\/div>\n<\/section>\n\n\n\n\u00ab\u00a0`html\n<style>\n  .mdx-client-voices {\n\n    --mdx-client-voices-surface: var(--color-white, #FFFFFF);\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=\"T\u00e9moignages clients\">\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          Une expertise reconnue en dispositifs m\u00e9dicaux. <span class=\"mdx-client-voices__title-highlight\">Des d\u00e9cisions \u00e9clair\u00e9es.<\/span>\n        <\/h2>\n      <\/div>\n\n      <div class=\"mdx-client-voices__score\" aria-label=\"Score NPS de plus 9, bas\u00e9 sur 159 r\u00e9ponses \u00e0 l'enqu\u00eate clients\">\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\">Bas\u00e9 sur 159 r\u00e9ponses \u00e0 l&rsquo;enqu\u00eate clients<\/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\">Ce que disent nos clients du secteur des dispositifs m\u00e9dicaux<\/h3>\n        <div class=\"mdx-client-voices__controls\" aria-label=\"Commandes des t\u00e9moignages\">\n          <button class=\"mdx-client-voices__control mdx-client-voices__control--prev\" type=\"button\" aria-label=\"T\u00e9moignage pr\u00e9c\u00e9dent\">\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=\"T\u00e9moignage suivant\">\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=\"T\u00e9moignages clients. Faites d\u00e9filer ou utilisez les boutons pr\u00e9c\u00e9dent et suivant pour les parcourir.\">\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\">Note : 10 sur 10<\/span>\n          <\/div>\n          <p class=\"mdx-client-voices__review\">Le travail et les efforts d\u00e9ploy\u00e9s par les membres de l&rsquo;\u00e9quipe MDx dans le cadre du projet de soutien en affaires r\u00e9glementaires sont remarquables. La qualit\u00e9 de leur travail est excellente et ils font toujours le n\u00e9cessaire pour r\u00e9pondre \u00e0 nos attentes, m\u00eame lorsque les d\u00e9lais sont particuli\u00e8rement exigeants.<\/p>\n          <footer class=\"mdx-client-voices__attribution\">\n            <span class=\"mdx-client-voices__role\">Client<\/span>\n            <span class=\"mdx-client-voices__company\">Argen Corporation<\/span>\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\">Note : 10 sur 10<\/span>\n          <\/div>\n          <p class=\"mdx-client-voices__review\">Je travaille comme chef de projet sur une \u00e9tude pivot. L&rsquo;\u00e9quipe MDx est tr\u00e8s impliqu\u00e9e et r\u00e9pond rapidement \u00e0 chacune de nos demandes. Je suis tr\u00e8s impressionn\u00e9 par leur travail et ravi de les compter parmi les membres de l&rsquo;\u00e9quipe.<\/p>\n          <footer class=\"mdx-client-voices__attribution\">\n            <span class=\"mdx-client-voices__role\">Chef de projet<\/span>\n            <span class=\"mdx-client-voices__company\">Entreprise de dispositifs m\u00e9dicaux<\/span>\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\">Note : 10 sur 10<\/span>\n          <\/div>\n          <p class=\"mdx-client-voices__review\">Les deux ARC affect\u00e9s \u00e0 l&rsquo;\u00e9tude \u00e9taient des professionnels de tout premier ordre, parmi les meilleurs ARC externes avec lesquels nous ayons jamais travaill\u00e9. Collaborer avec eux a \u00e9t\u00e9 un v\u00e9ritable plaisir.<\/p>\n          <footer class=\"mdx-client-voices__attribution\">\n            <span class=\"mdx-client-voices__role\">Client<\/span>\n            <span class=\"mdx-client-voices__company\">Cochlear<\/span>\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\">9\/10<\/span>\n            <span class=\"mdx-client-voices__sr-only\">Note : 9 sur 10<\/span>\n          <\/div>\n          <p class=\"mdx-client-voices__review\">Huiwen s&rsquo;est montr\u00e9e attentive, rigoureuse, responsable et disponible pour tous les sujets li\u00e9s \u00e0 l&rsquo;\u00e9tude concernant les centres espagnols. Le promoteur s&rsquo;est \u00e9galement d\u00e9clar\u00e9 tr\u00e8s satisfait de son travail et du d\u00e9roulement de l&rsquo;\u00e9tude en Espagne.<\/p>\n          <footer class=\"mdx-client-voices__attribution\">\n            <span class=\"mdx-client-voices__role\">Client<\/span>\n            <span class=\"mdx-client-voices__company\">Organisation de recherche clinique<\/span>\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\">Note : 10 sur 10<\/span>\n          <\/div>\n          <p class=\"mdx-client-voices__review\">Nous souhaitons remercier Andre et David pour la qualit\u00e9 exceptionnelle de leur service et de leur communication. Nous esp\u00e9rons que notre collaboration se poursuivra encore pendant de nombreuses ann\u00e9es.<\/p>\n          <footer class=\"mdx-client-voices__attribution\">\n            <span class=\"mdx-client-voices__role\">Client<\/span>\n            <span class=\"mdx-client-voices__company\">Entreprise de dispositifs m\u00e9dicaux<\/span>\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\">Note : 10 sur 10<\/span>\n          <\/div>\n          <p class=\"mdx-client-voices__review\">Je parle de MDx \u00e0 tous les dirigeants que je rencontre. Je suis tr\u00e8s heureux que nous ayons trouv\u00e9 cette organisation.<\/p>\n          <footer class=\"mdx-client-voices__attribution\">\n            <span class=\"mdx-client-voices__role\">Client<\/span>\n            <span class=\"mdx-client-voices__company\">Fertilis<\/span>\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\">9\/10<\/span>\n            <span class=\"mdx-client-voices__sr-only\">Note : 9 sur 10<\/span>\n          <\/div>\n          <p class=\"mdx-client-voices__review\">J&rsquo;ai principalement travaill\u00e9 avec une consultante que j&rsquo;ai trouv\u00e9e tr\u00e8s fiable et avec laquelle il \u00e9tait tr\u00e8s agr\u00e9able de collaborer. Son travail \u00e9tait toujours livr\u00e9 dans les d\u00e9lais et d&rsquo;une excellente qualit\u00e9.<\/p>\n          <footer class=\"mdx-client-voices__attribution\">\n            <span class=\"mdx-client-voices__role\">Client<\/span>\n            <span class=\"mdx-client-voices__company\">Entreprise de dispositifs m\u00e9dicaux<\/span>\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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Contrairement aux CRO pharmaceutiques, qui se concentrent sur des essais de m\u00e9dicaments r\u00e9gis par l\u2019ICH-GCP, une CRO pour dispositifs m\u00e9dicaux op\u00e8re selon des cadres sp\u00e9cifiques aux dispositifs, tels que l\u2019ISO 14155, le r\u00e8glement (UE) MDR 2017\/745 et la FDA 21 CFR 812. <\/span><\/p>\n<p><span style=\"font-weight: 400\">Cette distinction compte davantage que la plupart des fabricants ne l\u2019imaginent. Les investigations cliniques de dispositifs m\u00e9dicaux ont des exigences fondamentalement diff\u00e9rentes : cycles de d\u00e9veloppement plus courts, conception it\u00e9rative du dispositif pendant les \u00e9tudes, structures de crit\u00e8res d\u2019\u00e9valuation diff\u00e9rentes et voies r\u00e9glementaires (marquage CE, 510(k), PMA) qui exigent une expertise sp\u00e9cialis\u00e9e. <\/span><\/p>\n<p><span style=\"font-weight: 400\">Une CRO qualifi\u00e9e pour dispositifs m\u00e9dicaux g\u00e8re l\u2019ensemble du cycle de vie de l\u2019investigation clinique : de la strat\u00e9gie clinique et la conception de l\u2019\u00e9tude, aux soumissions aux comit\u00e9s d\u2019\u00e9thique et aux autorit\u00e9s comp\u00e9tentes, en passant par la s\u00e9lection des centres, le recrutement des patients, le monitoring, la gestion des donn\u00e9es et la r\u00e9daction m\u00e9dicale, jusqu\u2019au rapport final d\u2019investigation clinique et au d\u00e9p\u00f4t r\u00e9glementaire.<\/span><\/p>\n<p><span style=\"font-weight: 400\">La question critique n\u2019est pas de savoir si vous avez besoin d\u2019une CRO, mais si votre CRO comprend r\u00e9ellement les dispositifs m\u00e9dicaux. Comme le souligne Alberto Bardaj\u00ed, responsable Dispositifs m\u00e9dicaux chez MDx et ancien \u00e9valuateur senior d\u2019organisme notifi\u00e9 : \u00ab L\u2019erreur la plus fr\u00e9quente que nous constatons est que les fabricants choisissent une CRO qui n\u2019est pas enti\u00e8rement sp\u00e9cialis\u00e9e dans les dispositifs m\u00e9dicaux. Une conception d\u2019\u00e9tude qui fonctionne pour un essai de m\u00e9dicament ne produit pas le type de preuves dont les organismes notifi\u00e9s ont besoin pour la certification des dispositifs. Cela entra\u00eene des refontes, des retards et une augmentation significative des co\u00fbts. \u00bb <\/span><\/p>\n<p><strong>Pour un cadre d\u00e9taill\u00e9 sur la mani\u00e8re d\u2019\u00e9valuer des partenaires CRO, lisez notre guide complet : CRO pour dispositifs m\u00e9dicaux : comment qualifier votre partenaire clinique, par David Tom\u00e9, Pr\u00e9sident de MDx.<\/strong><\/p>\n<\/div><a class=\"button\" href=\"https:\/\/mdxcro.com\/medical-device-cro-how-to-qualify-your-clinical-partner\/\" target=\"_self\">Lire notre guide complet<\/a><\/div><\/div>                        <div class=\"column column--image\"><\/div>                    <\/div>\n                <\/div>\n            <\/section>\n        <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section class=\"key-stats key-stats--bg-white\"  style=\"\">\n    <div class=\"container\">\n          <div class=\"headline\">La meilleure CRO pour dispositifs m\u00e9dicaux<\/div>\n    \n    <div class=\"main-wrapper\">\n              <div class=\"box-grid\">\n                                    <div class=\"box\">\n                                  <div class=\"value\">9.4\/10<\/div>\n                                                  <div class=\"legend\">Satisfaction client<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">50+<\/div>\n                                                  <div class=\"legend\">investigations cliniques de dispositifs m\u00e9dicaux<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">100%  <\/div>\n                                                  <div class=\"legend\">taux de r\u00e9ussite des soumissions MDR<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">20+  <\/div>\n                                                  <div class=\"legend\">pays<\/div>\n                              <\/div>\n                              <\/div>\n      \n          <\/div>\n\n    <div class=\"data\">\n      \n          <\/div>\n  <\/div>\n<\/section>\n\n\n\n<section id=\"block_e58879623ca3736f8c6bfb609fa8cb9d\" class=\"text-image text-image--reverse\" style=\"padding-top: var(--wp--preset--spacing--regular); padding-bottom: var(--wp--preset--spacing--regular); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Pourquoi MDx est votre partenaire CRO id\u00e9al pour les dispositifs m\u00e9dicaux en Europe<\/h2><div class=\"description wysiwyg\"><p>La plupart des CRO mondiales ont \u00e9t\u00e9 con\u00e7ues pour le d\u00e9veloppement pharmaceutique. Leurs processus, SOP et structures d\u2019\u00e9quipe sont pens\u00e9s autour des essais de m\u00e9dicaments, et elles les adaptent aux dispositifs a posteriori. MDx CRO a \u00e9t\u00e9 con\u00e7ue d\u00e8s le d\u00e9part pour la MedTech. Ce n\u2019est pas une nuance.   <\/p>\n<p><strong>Lorsqu\u2019un fabricant confie \u00e0 MDx un dispositif implantable de classe III, l\u2019approche est fondamentalement diff\u00e9rente de celle d\u2019une CRO g\u00e9n\u00e9raliste :<\/strong><\/p>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/yaiza-hugo-scaled.jpg\" alt=\"Innovative MedTech collaboration, professionals discussing medical technology advancements, representing MDX&#039;s role in accelerating medical innovation and healthcare solutions.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section id=\"block_ae37b571604d4c87afeb72bb63c2b882\" class=\"text-image-wrapper\" style=\"\">\n    <div class=\"container\">\n                <div class=\"grid-wrapper\">\n            <section class=\"text-image text-image--reverse\">\n                <div class=\"container\">\n                    <div class=\"grid\">\n                        <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">1. Une expertise d\u2019organisme notifi\u00e9 \u00e0 vos c\u00f4t\u00e9s<\/h2><div class=\"description wysiwyg\"><p>L\u2019\u00e9quipe dispositifs m\u00e9dicaux de MDx est dirig\u00e9e par Alberto Bardaj\u00ed, ancien \u00e9valuateur senior d\u2019organisme notifi\u00e9 et auditeur QMS. Cela signifie que MDx ne se contente pas de pr\u00e9parer des soumissions : l\u2019\u00e9quipe anticipe pr\u00e9cis\u00e9ment ce que les \u00e9valuateurs rechercheront, identifie les lacunes avant le d\u00e9p\u00f4t et r\u00e9duit les non-conformit\u00e9s et les cycles de revue. R\u00e9sultat : moins de questions, des approbations plus rapides.  <\/p>\n<\/div><\/div><\/div>                        <div class=\"column column--image\"><\/div>                    <\/div>\n                <\/div>\n            <\/section>\n            <section class=\"text-image text-image--reverse\">\n                <div class=\"container\">\n                    <div class=\"grid\">\n                        <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">2. Des processus natifs ISO 14155<\/h2><div class=\"description wysiwyg\"><p>De nombreuses CRO revendiquent la conformit\u00e9 \u00e0 l\u2019ISO 14155, mais op\u00e8rent avec des processus adapt\u00e9s d\u2019\u00e9tudes pharmaceutiques. MDx dispose, d\u00e8s le premier jour, de SOP sp\u00e9cifiques aux dispositifs, pleinement align\u00e9es sur l\u2019ISO 14155 et le MDR. Chaque \u00e9tude est pr\u00eate pour audit d\u00e8s le d\u00e9part, et non adapt\u00e9e pour la conformit\u00e9 \u00e0 la fin.  <\/p>\n<p>\u00ab Une question que chaque fabricant devrait poser \u00e0 sa CRO, mais ne pose presque jamais, est : comment garantissez-vous concr\u00e8tement la conformit\u00e9 \u00e0 l\u2019ISO 14155 ? \u00bb, explique Alberto. \u00ab Les \u00e9carts de conformit\u00e9 sont souvent identifi\u00e9s tardivement, lors d\u2019audits ou de soumissions, entra\u00eenant des retards importants. Nous int\u00e9grons la conformit\u00e9 dans l\u2019\u00e9tude d\u00e8s le d\u00e9but. \u00bb <\/p>\n<\/div><\/div><\/div>                        <div class=\"column column--image\"><\/div>                    <\/div>\n                <\/div>\n            <\/section>\n        <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section id=\"block_3f324f09dbe22547fcebca26f2cf29ca\" class=\"text-image-wrapper\" style=\"\">\n    <div class=\"container\">\n                <div class=\"grid-wrapper\">\n            <section class=\"text-image text-image--reverse\">\n                <div class=\"container\">\n                    <div class=\"grid\">\n                        <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">3. Une strat\u00e9gie int\u00e9gr\u00e9e clinique + r\u00e9glementaire + certification<\/h2><div class=\"description wysiwyg\"><p>MDx aligne simultan\u00e9ment la conception de l\u2019investigation clinique avec la documentation technique, la gestion des risques et les attentes des organismes notifi\u00e9s. Cette approche int\u00e9gr\u00e9e permet des d\u00e9lais ~20\u201330 % plus rapides que les r\u00e9f\u00e9rences du secteur et un taux de r\u00e9ussite de 100 % des soumissions MDR pour les dispositifs m\u00e9dicaux. <\/p>\n<\/div><\/div><\/div>                        <div class=\"column column--image\"><\/div>                    <\/div>\n                <\/div>\n            <\/section>\n            <section class=\"text-image text-image--reverse\">\n                <div class=\"container\">\n                    <div class=\"grid\">\n                        <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">4. Une exp\u00e9rience de soumissions multi-pays<\/h2><div class=\"description wysiwyg\"><p>MDx a d\u00e9pos\u00e9 des dossiers d\u2019investigation clinique dans plus de 20 pays, principalement en Europe. Que votre \u00e9tude n\u00e9cessite des centres en Allemagne, en Espagne, en Italie, en France ou au-del\u00e0, MDx g\u00e8re les soumissions aux autorit\u00e9s comp\u00e9tentes et aux comit\u00e9s d\u2019\u00e9thique avec des processus \u00e9prouv\u00e9s. <\/p>\n<\/div><\/div><\/div>                        <div class=\"column column--image\"><\/div>                    <\/div>\n                <\/div>\n            <\/section>\n        <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section id=\"block_0e4bcc6f9fb9e07b921360476e9b6ff0\" class=\"text-image-wrapper\" style=\"\">\n    <div class=\"container\">\n                <div class=\"grid-wrapper\">\n            <section class=\"text-image text-image--reverse\">\n                <div class=\"container\">\n                    <div class=\"grid\">\n                        <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">5. Une exp\u00e9rience \u00e9prouv\u00e9e sur l\u2019ensemble des classes de dispositifs<\/h2><div class=\"description wysiwyg\"><p>Avec plus de 50 investigations cliniques de dispositifs m\u00e9dicaux g\u00e9r\u00e9es, l\u2019exp\u00e9rience de MDx couvre les cat\u00e9gories de dispositifs les plus exigeantes :<\/p>\n<ul>\n<li>Dispositifs implantables de classe IIb et de classe III<\/li>\n<li>Cardiologie (stents, cath\u00e9ters, dispositifs pour l\u2019AVC)<\/li>\n<li>Neurologie (neurostimulation, monitoring)<\/li>\n<li>Ophtalmologie<\/li>\n<li>Dispositifs esth\u00e9tiques et dermatologiques<\/li>\n<li>Sant\u00e9 num\u00e9rique et Software as a Medical Device (SaMD)<\/li>\n<li>Chirurgie g\u00e9n\u00e9rale et technologies mini-invasives<\/li>\n<\/ul>\n<\/div><\/div><\/div>                        <div class=\"column column--image\"><\/div>                    <\/div>\n                <\/div>\n            <\/section>\n            <section class=\"text-image text-image--reverse\">\n                <div class=\"container\">\n                    <div class=\"grid\">\n                        <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">6. Capacit\u00e9 de sauvetage d\u2019\u00e9tudes<\/h2><div class=\"description wysiwyg\"><p>MDx a repris et redress\u00e9 plusieurs \u00e9tudes de dispositifs m\u00e9dicaux auparavant g\u00e9r\u00e9es par d\u2019autres CRO. Les probl\u00e8mes courants incluent une strat\u00e9gie r\u00e9glementaire faible, un manque d\u2019alignement entre les crit\u00e8res d\u2019\u00e9valuation de l\u2019investigation clinique et les all\u00e9gations du dispositif, ainsi qu\u2019une documentation insuffisante. Dans chaque cas, MDx a red\u00e9fini la strat\u00e9gie clinique et r\u00e9glementaire, r\u00e9align\u00e9 le plan d\u2019investigation clinique avec la documentation technique et r\u00e9tabli la validit\u00e9 de l\u2019\u00e9tude, ouvrant une voie claire vers l\u2019approbation r\u00e9glementaire.  <\/p>\n<\/div><\/div><\/div>                        <div class=\"column column--image\"><\/div>                    <\/div>\n                <\/div>\n            <\/section>\n        <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section id=\"block_ba4b16606bd12f363373750627d3193d\" class=\"flip-cards flip-cards--four-columns flip-cards--grayscale \" style=\"\">\n            <div class=\"container\">\n        <div class=\"content\">\n            \n                            <h2 class=\"title\">Nos services de CRO pour dispositifs m\u00e9dicaux<\/h2>\n            \n            \n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <a 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;);\"                         href=\"https:\/\/mdxcro.com\/fr\/services\/qualite-affaires-reglementaires\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Affaires r\u00e9glementaires &amp; documentation technique<\/div>\n                        <div class=\"back\"><p>Dossiers techniques, CER, plans PMCF et enregistrements EUDAMED pour la conformit\u00e9 MDR.<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--background-black\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/etudes-cliniques-dispositifs-diagnostic-in-vitro\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">\u00c9tudes cliniques DIV<\/div>\n                        <div class=\"back\"><p>\u00c9tudes de performance clinique et validation analytique selon l\u2019IVDR et l\u2019ISO 20916.<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--background-blue\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/ingenierie-utilisabilite\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Ing\u00e9nierie de l\u2019aptitude \u00e0 l\u2019utilisation<\/div>\n                        <div class=\"back\"><p>\u00c9valuations d\u2019utilisabilit\u00e9 conformes \u00e0 l\u2019IEC 62366, \u00e9tudes formatives et sommatives, facteurs humains.<\/p>\n<\/div>\n                    <\/a>\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\">Diagnostics compagnons<\/div>\n                        <div class=\"back\"><p>Strat\u00e9gie de d\u00e9veloppement CDx, \u00e9tudes selon l\u2019annexe XIV de l\u2019IVDR, voie FDA PMA pour les CDx.<\/p>\n<\/div>\n                    <\/div>\n                                    <a class=\"card card--background-black\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/audit-risques-qualite\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Qualit\u00e9 &amp; gestion des risques<\/div>\n                        <div class=\"back\"><\/div>\n                    <\/a>\n                                    <a class=\"card card--background-blue\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/formation-conseil\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Formation et conseil<\/div>\n                        <div class=\"back\"><p>Formations r\u00e9glementaires, ateliers et conseil strat\u00e9gique pour les \u00e9quipes MedTech.<\/p>\n<\/div>\n                    <\/a>\n                                    <a 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-Training-Consultancy.webp&#039;);\"                         href=\"https:\/\/mdxcro.com\/fr\/services\/services-de-representation\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Repr\u00e9sentant autoris\u00e9 dans l\u2019UE<\/div>\n                        <div class=\"back\"><\/div>\n                    <\/a>\n                                    <a class=\"card card--background-white\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/logiciels-sante-numerique-ia\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Logiciels, sant\u00e9 num\u00e9rique et IA<\/div>\n                        <div class=\"back\"><p>Classification SaMD, conformit\u00e9 MDR\/IVDR, pr\u00e9paration \u00e0 l\u2019EU AI Act.<\/p>\n<\/div>\n                    <\/a>\n                            <\/div>\n        \n            <\/div>\n<\/section>\n\n\n<section id=\"block_1767118e30f255b0bff2d91be60687c8\" class=\"text-image text-image--reverse text-image--grayscale\" style=\"padding-top: var(--wp--preset--spacing--regular); padding-bottom: var(--wp--preset--spacing--regular); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Dispositif implantable de classe III, certification MDR<\/h2><div class=\"description wysiwyg\"><p><b>D\u00e9fi :  <\/b><span style=\"font-weight: 400\">Un fabricant devait faire passer un dispositif implantable de classe III d\u2019une certification MDD \u00e0 une certification MDR. Il existait des lacunes importantes en mati\u00e8re de preuves cliniques et de documentation technique, avec un niveau \u00e9lev\u00e9 de scrutiny de la part de l\u2019organisme notifi\u00e9. <\/span><\/p>\n<p><b>Approche MDx :  <span style=\"font-weight: 400\">Mise en place d\u2019une strat\u00e9gie pleinement int\u00e9gr\u00e9e clinique + r\u00e9glementaire + certification. Alignement des preuves cliniques sur les attentes de l\u2019organisme notifi\u00e9. Renforcement du rapport d\u2019\u00e9valuation clinique, des dossiers de gestion des risques et de la documentation technique.<br \/>\n<\/span><br \/>\nR\u00e9sultat :  <\/b><span style=\"font-weight: 400\">Certification MDR r\u00e9ussie avec z\u00e9ro non-conformit\u00e9 majeure. \u00c9vitement des retards typiques des transitions MDD vers MDR. <\/span><\/p>\n<\/div><a class=\"button\" href=\"https:\/\/mdxcro.com\/case-study-how-mdx-enabled-argens-successful-transition-to-mdr-ce-marking-for-dental-alloys\/\" target=\"_self\">Lire l\u2019\u00e9tude de cas compl\u00e8te<\/a><\/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\n\n<section id=\"block_e00f8d8a5843ca032c51187d3bca8170\" class=\"faqs\" style=\"padding-top: var(--wp--preset--spacing--regular); padding-bottom: var(--wp--preset--spacing--regular); margin-top: Par d\u00e9faut; margin-bottom: Par d\u00e9faut; \">\n    <div class=\"container\">\n    <div class=\"content\">\n      <div class=\"column\">\n                  <h2 class=\"headline\">Questions fr\u00e9quentes sur les CRO pour dispositifs m\u00e9dicaux<\/h2>\n                      <\/div>\n      <div class=\"column\">\n                  <ul class=\"faq-list\">\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Qu\u2019est-ce qu\u2019une CRO pour dispositifs m\u00e9dicaux ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Une CRO pour dispositifs m\u00e9dicaux (Contract Research Organization) est une entreprise sp\u00e9cialis\u00e9e qui con\u00e7oit, g\u00e8re et ex\u00e9cute des investigations cliniques pour les fabricants de dispositifs m\u00e9dicaux. Contrairement aux CRO pharmaceutiques, une CRO pour dispositifs m\u00e9dicaux op\u00e8re selon des r\u00e9glementations sp\u00e9cifiques aux dispositifs, notamment l\u2019ISO 14155, le r\u00e8glement (UE) MDR 2017\/745 et la FDA 21 CFR 812. Les services incluent g\u00e9n\u00e9ralement la gestion des investigations cliniques, les rapports d\u2019\u00e9valuation clinique (CER), le suivi clinique apr\u00e8s commercialisation (PMCF), la documentation technique et le support aux soumissions r\u00e9glementaires.  <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Quelles classes de dispositifs et aires th\u00e9rapeutiques MDx couvre-t-elle ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">MDx a g\u00e9r\u00e9 plus de 50 investigations cliniques, principalement pour des dispositifs m\u00e9dicaux de classe IIb et de classe III. Les aires th\u00e9rapeutiques incluent la cardiologie, la neurologie, l\u2019ophtalmologie, l\u2019esth\u00e9tique\/la dermatologie, la sant\u00e9 num\u00e9rique, le SaMD et la chirurgie g\u00e9n\u00e9rale. MDx couvre \u00e9galement les dispositifs IVD dans le cadre de l\u2019IVDR.  <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">En quoi la pr\u00e9sence d\u2019anciens \u00e9valuateurs d\u2019organismes notifi\u00e9s dans l\u2019\u00e9quipe b\u00e9n\u00e9ficie-t-elle \u00e0 mon projet ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Les anciens \u00e9valuateurs d\u2019organismes notifi\u00e9s anticipent pr\u00e9cis\u00e9ment ce que les examinateurs recherchent dans les soumissions, identifient les lacunes documentaires avant le d\u00e9p\u00f4t et contribuent \u00e0 r\u00e9duire les non-conformit\u00e9s et les cycles de revue. Cela se traduit par moins de questions, des approbations plus rapides et un risque nettement r\u00e9duit de rejet ou de retard lors de la certification MDR. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Dans combien de pays MDx peut-elle g\u00e9rer des investigations cliniques ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">MDx a d\u00e9pos\u00e9 des dossiers d\u2019investigation clinique dans plus de 20 pays, principalement en Europe. Cela inclut les demandes aupr\u00e8s des autorit\u00e9s comp\u00e9tentes, les soumissions aux comit\u00e9s d\u2019\u00e9thique et la gestion des centres dans plusieurs \u00c9tats membres de l\u2019UE. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">MDx peut-elle reprendre une \u00e9tude pr\u00e9c\u00e9demment g\u00e9r\u00e9e par une autre CRO ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Oui. MDx a redress\u00e9 avec succ\u00e8s plusieurs \u00e9tudes de dispositifs m\u00e9dicaux. Les probl\u00e8mes courants incluent une strat\u00e9gie r\u00e9glementaire faible, un manque d\u2019alignement entre les crit\u00e8res d\u2019\u00e9valuation de l\u2019\u00e9tude et les all\u00e9gations du dispositif, ainsi qu\u2019une documentation insuffisante. MDx red\u00e9finit la strat\u00e9gie clinique et r\u00e9glementaire, r\u00e9aligne le plan d\u2019investigation avec la documentation technique et r\u00e9tablit la validit\u00e9 de l\u2019\u00e9tude.   <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Combien de temps dure g\u00e9n\u00e9ralement une investigation clinique de dispositif m\u00e9dical ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Les d\u00e9lais varient fortement selon la classe du dispositif, la complexit\u00e9 de l\u2019\u00e9tude et le nombre de pays. Toutefois, MDx obtient g\u00e9n\u00e9ralement des d\u00e9lais 20\u201330 % plus rapides que les r\u00e9f\u00e9rences du secteur gr\u00e2ce \u00e0 une meilleure qualit\u00e9 du premier coup, \u00e0 moins de cycles de revue et \u00e0 une approche clinique-r\u00e9glementaire int\u00e9gr\u00e9e. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Quelle est la diff\u00e9rence entre une CRO pour dispositifs m\u00e9dicaux et un consultant r\u00e9glementaire ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Un consultant r\u00e9glementaire fournit des services de conseil, d\u2019orientation strat\u00e9gique, de revue documentaire ou d\u2019analyse des \u00e9carts. Une CRO full-service pour dispositifs m\u00e9dicaux prend en charge et ex\u00e9cute les livrables : elle g\u00e8re les investigations cliniques de bout en bout, produit une documentation pr\u00eate \u00e0 \u00eatre soumise et assume la responsabilit\u00e9 des r\u00e9sultats. Pour les projets complexes impliquant la g\u00e9n\u00e9ration de preuves cliniques, la capacit\u00e9 int\u00e9gr\u00e9e d\u2019une CRO est essentielle.  <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                      <\/ul>\n              <\/div>\n    <\/div>\n  <\/div>\n<\/section>\n\n  <script type=\"application\/ld+json\">\n    {\"@context\":\"https:\/\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Qu\u2019est-ce qu\u2019une CRO pour dispositifs m\u00e9dicaux ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Une CRO pour dispositifs m\u00e9dicaux (Contract Research Organization) est une entreprise sp\u00e9cialis\u00e9e qui con\u00e7oit, g\u00e8re et ex\u00e9cute des investigations cliniques pour les fabricants de dispositifs m\u00e9dicaux. 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Cela se traduit par moins de questions, des approbations plus rapides et un risque nettement r\u00e9duit de rejet ou de retard lors de la certification MDR.\"}},{\"@type\":\"Question\",\"name\":\"Dans combien de pays MDx peut-elle g\u00e9rer des investigations cliniques ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"MDx a d\u00e9pos\u00e9 des dossiers d\u2019investigation clinique dans plus de 20 pays, principalement en Europe. Cela inclut les demandes aupr\u00e8s des autorit\u00e9s comp\u00e9tentes, les soumissions aux comit\u00e9s d\u2019\u00e9thique et la gestion des centres dans plusieurs \u00c9tats membres de l\u2019UE.\"}},{\"@type\":\"Question\",\"name\":\"MDx peut-elle reprendre une \u00e9tude pr\u00e9c\u00e9demment g\u00e9r\u00e9e par une autre CRO ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Oui. MDx a redress\u00e9 avec succ\u00e8s plusieurs \u00e9tudes de dispositifs m\u00e9dicaux. 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Pour les projets complexes impliquant la g\u00e9n\u00e9ration de preuves cliniques, la capacit\u00e9 int\u00e9gr\u00e9e d\u2019une CRO est essentielle.\"}}]}  <\/script>\n\n\n\n<section id=\"block_464ffb4445ab51901d5b87ba623c5e27\" class=\"text-image text-image--reverse text-image--grayscale\" style=\"padding-top: var(--wp--preset--spacing--regular); padding-bottom: var(--wp--preset--spacing--regular); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Alberto Bardaj\u00ed | Responsable Dispositifs m\u00e9dicaux<\/h2><div class=\"description wysiwyg\"><p><span style=\"font-weight: 400\">Alberto supervise la strat\u00e9gie r\u00e9glementaire des dispositifs m\u00e9dicaux, les interactions avec les organismes notifi\u00e9s et la FDA, ainsi que le support QMS chez MDx CRO. Ancien \u00e9valuateur senior d\u2019organisme notifi\u00e9 et auditeur QMS, il apporte une exp\u00e9rience directe de l\u2019\u00e9valuation des soumissions de dispositifs du point de vue de l\u2019examinateur. <\/span><\/p>\n<p><span style=\"font-weight: 400\">Son expertise couvre les dispositifs implantables (dentaire, orthop\u00e9die, traumatologie), les dispositifs actifs et les logiciels (SaMD), ainsi que des projets complexes de certification MDR. Alberto travaille en \u00e9troite collaboration avec les \u00e9quipes cliniques afin de garantir que chaque \u00e9tude est con\u00e7ue, d\u00e8s le d\u00e9part, pour r\u00e9pondre aux exigences de certification. <\/span><\/p>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/Alberto-Bardaji.jpeg\" alt=\"Professional businessman in an office setting, representing innovation and leadership in MedTech and healthcare technology.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section id=\"block_e1519ef4a7380f3fa46f18083effde2d\" class=\"call-to-action\" style=\"padding-top: Par d\u00e9faut; padding-bottom: Par d\u00e9faut; margin-top: Par d\u00e9faut; margin-bottom: Par d\u00e9faut; \">\n        <div class=\"call-to-action--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/mdx-cta-bg.png\" alt=\"\" \/>\n    <\/div>\n    <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"content\">\n                                    <h2 class=\"title\">Pr\u00eat \u00e0 lancer votre investigation clinique de dispositif m\u00e9dical ?<\/h2>\n                \n                                    <div class=\"description wysiwyg\">\n                        <p><span style=\"font-weight: 400;\">Contactez directement notre \u00e9quipe dispositifs m\u00e9dicaux. Que vous planifiiez une \u00e9tude first-in-human, que vous g\u00e9riez une transition MDD vers MDR ou que vous ayez besoin d\u2019un support post-commercialisation, nos experts sont pr\u00eats \u00e0 discuter de votre projet. <\/span><\/p>\n                    <\/div>\n                            <\/div>\n\n                            <div class=\"button-wrapper\">\n                                                                        <a href=\"https:\/\/mdxcro.com\/fr\/contact\/\" class=\"button button--secondary\" target=\"\">\n                                Planifier une consultation                            <\/a>\n                                                            <\/div>\n                    <\/div>\n    <\/div>\n<\/section>\n","protected":false},"excerpt":{"rendered":"<p>\u00ab\u00a0`html Une expertise reconnue en dispositifs m\u00e9dicaux. Des d\u00e9cisions \u00e9clair\u00e9es. +9 NPS Bas\u00e9 sur 159 r\u00e9ponses \u00e0 l&rsquo;enqu\u00eate clients Ce que disent nos clients du secteur des dispositifs m\u00e9dicaux \u2605\u2605\u2605\u2605\u2605 10\/10 Note : 10 sur 10 Le travail et les efforts d\u00e9ploy\u00e9s par les membres de l&rsquo;\u00e9quipe MDx dans le cadre du projet de soutien [&hellip;]<\/p>\n","protected":false},"author":11,"featured_media":11403,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-11401","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CRO pour dispositifs m\u00e9dicaux et services de recherche clinique | MDx CRO<\/title>\n<meta name=\"description\" content=\"CRO europ\u00e9enne sp\u00e9cialis\u00e9e en dispositifs m\u00e9dicaux, avec plus de 50 investigations cliniques dans plus de 20 pays. 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