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elementor-size-default">Affaires réglementaires</h1> </div> </div> <div class="elementor-element elementor-element-73fe1e8 elementor-widget elementor-widget-heading" data-id="73fe1e8" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default">En nous focalisant sur l'excellence réglementaire, nous permettons à nos clients de mettre sur le marché leurs kits de diagnostic IVD en toute sécurité et dans le respect de la réglementation.</h2> </div> </div> </div> </div> <div class="elementor-element elementor-element-01b8954 e-con-full e-flex e-con e-parent" data-id="01b8954" data-element_type="container" data-settings="{&quot;background_background&quot;:&quot;classic&quot;}"> <div class="elementor-element elementor-element-2ff67a9 e-flex e-con-boxed e-con e-child" data-id="2ff67a9" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-fd936c2 elementor-invisible elementor-widget elementor-widget-text-editor" data-id="fd936c2" data-element_type="widget" data-settings="{&quot;_animation&quot;:&quot;fadeIn&quot;,&quot;_animation_delay&quot;:300}" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Notre département des affaires réglementaires s&rsquo;engage à guider nos clients à travers les processus réglementaires des marchés de l&rsquo;UE et des États-Unis, en fournissant un soutien au marquage CE ou au processus de soumission à la FDA.</p><p>Grâce à notre vaste expertise dans divers domaines thérapeutiques, phases de développement et industries, ainsi qu&rsquo;à notre connaissance approfondie des environnements réglementaires, nous aidons nos clients à commercialiser leurs kits de diagnostic in vitro en toute confiance.</p> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-48515b7 e-flex e-con-boxed e-con e-parent" data-id="48515b7" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-c33791e elementor-widget elementor-widget-heading" data-id="c33791e" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default">CE QUE NOUS OFFRONS</h2> </div> </div> <div class="elementor-element elementor-element-e5bab6d elementor-widget-divider--view-line elementor-widget elementor-widget-divider" data-id="e5bab6d" data-element_type="widget" data-widget_type="divider.default"> <div class="elementor-widget-container"> <div class="elementor-divider"> <span class="elementor-divider-separator"> </span> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-fcb2034 e-flex e-con-boxed e-con e-parent" data-id="fcb2034" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-700510c e-con-full animated-slow e-flex elementor-invisible e-con e-child" data-id="700510c" data-element_type="container" data-settings="{&quot;animation&quot;:&quot;fadeIn&quot;,&quot;animation_delay&quot;:200}"> <div class="elementor-element elementor-element-d484ea9 elementor-view-default elementor-widget elementor-widget-icon" data-id="d484ea9" data-element_type="widget" data-widget_type="icon.default"> <div class="elementor-widget-container"> <div class="elementor-icon-wrapper"> <div class="elementor-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-far-file-alt" viewBox="0 0 384 512" xmlns="http://www.w3.org/2000/svg"><path d="M288 248v28c0 6.6-5.4 12-12 12H108c-6.6 0-12-5.4-12-12v-28c0-6.6 5.4-12 12-12h168c6.6 0 12 5.4 12 12zm-12 72H108c-6.6 0-12 5.4-12 12v28c0 6.6 5.4 12 12 12h168c6.6 0 12-5.4 12-12v-28c0-6.6-5.4-12-12-12zm108-188.1V464c0 26.5-21.5 48-48 48H48c-26.5 0-48-21.5-48-48V48C0 21.5 21.5 0 48 0h204.1C264.8 0 277 5.1 286 14.1L369.9 98c9 8.9 14.1 21.2 14.1 33.9zm-128-80V128h76.1L256 51.9zM336 464V176H232c-13.3 0-24-10.7-24-24V48H48v416h288z"></path></svg> </div> </div> </div> </div> <div class="elementor-element elementor-element-5f760e1 elementor-widget elementor-widget-heading" data-id="5f760e1" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h3 class="elementor-heading-title elementor-size-default">Conformité réglementaire </h3> </div> </div> <div class="elementor-element elementor-element-2764aab elementor-widget elementor-widget-text-editor" data-id="2764aab" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>S&rsquo;assurer que le kit IVD est conforme aux réglementations pertinentes dans les régions où il sera commercialisé, telles que la FDA aux États-Unis, la directive CE dans l&rsquo;Union européenne, ou d&rsquo;autres réglementations nationales ou internationales.</p> </div> </div> </div> <div class="elementor-element elementor-element-a5df8bb e-con-full animated-slow e-flex elementor-invisible e-con e-child" data-id="a5df8bb" data-element_type="container" data-settings="{&quot;animation&quot;:&quot;fadeIn&quot;,&quot;animation_delay&quot;:300}"> <div class="elementor-element elementor-element-dfe5594 elementor-view-default elementor-widget elementor-widget-icon" data-id="dfe5594" data-element_type="widget" data-widget_type="icon.default"> <div class="elementor-widget-container"> <div class="elementor-icon-wrapper"> <div class="elementor-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-far-clipboard" viewBox="0 0 384 512" xmlns="http://www.w3.org/2000/svg"><path d="M336 64h-80c0-35.3-28.7-64-64-64s-64 28.7-64 64H48C21.5 64 0 85.5 0 112v352c0 26.5 21.5 48 48 48h288c26.5 0 48-21.5 48-48V112c0-26.5-21.5-48-48-48zM192 40c13.3 0 24 10.7 24 24s-10.7 24-24 24-24-10.7-24-24 10.7-24 24-24zm144 418c0 3.3-2.7 6-6 6H54c-3.3 0-6-2.7-6-6V118c0-3.3 2.7-6 6-6h42v36c0 6.6 5.4 12 12 12h168c6.6 0 12-5.4 12-12v-36h42c3.3 0 6 2.7 6 6z"></path></svg> </div> </div> </div> </div> <div class="elementor-element elementor-element-056b0dd elementor-widget elementor-widget-heading" data-id="056b0dd" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h3 class="elementor-heading-title elementor-size-default">Évaluation des risques </h3> </div> </div> <div class="elementor-element elementor-element-d2b9b73 elementor-widget elementor-widget-text-editor" data-id="d2b9b73" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Effectuer une évaluation approfondie des risques associés au kit IVD, y compris les risques liés à la santé des patients, à la précision des résultats et à la sécurité de l&rsquo;utilisateur.</p> </div> </div> </div> <div class="elementor-element elementor-element-3c9a07d e-con-full animated-slow e-flex elementor-invisible e-con e-child" data-id="3c9a07d" data-element_type="container" data-settings="{&quot;animation&quot;:&quot;fadeIn&quot;,&quot;animation_delay&quot;:500}"> <div class="elementor-element elementor-element-ee1c703 elementor-view-default elementor-widget elementor-widget-icon" data-id="ee1c703" data-element_type="widget" data-widget_type="icon.default"> <div class="elementor-widget-container"> <div class="elementor-icon-wrapper"> <div class="elementor-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-far-check-circle" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M256 8C119.033 8 8 119.033 8 256s111.033 248 248 248 248-111.033 248-248S392.967 8 256 8zm0 48c110.532 0 200 89.451 200 200 0 110.532-89.451 200-200 200-110.532 0-200-89.451-200-200 0-110.532 89.451-200 200-200m140.204 130.267l-22.536-22.718c-4.667-4.705-12.265-4.736-16.97-.068L215.346 303.697l-59.792-60.277c-4.667-4.705-12.265-4.736-16.97-.069l-22.719 22.536c-4.705 4.667-4.736 12.265-.068 16.971l90.781 91.516c4.667 4.705 12.265 4.736 16.97.068l172.589-171.204c4.704-4.668 4.734-12.266.067-16.971z"></path></svg> </div> </div> </div> </div> <div class="elementor-element elementor-element-e3d4e9b elementor-widget elementor-widget-heading" data-id="e3d4e9b" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h3 class="elementor-heading-title elementor-size-default">Validation du processus </h3> </div> </div> <div class="elementor-element elementor-element-c40f1e4 elementor-widget elementor-widget-text-editor" data-id="c40f1e4" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Valider les processus de fabrication, d&rsquo;assemblage et de contrôle de la qualité pour garantir la fiabilité et la reproductibilité des résultats du kit IVD.</p> </div> </div> </div> <div class="elementor-element elementor-element-6e1b7a9 e-con-full animated-slow e-flex elementor-invisible e-con e-child" data-id="6e1b7a9" data-element_type="container" data-settings="{&quot;animation&quot;:&quot;fadeIn&quot;,&quot;animation_delay&quot;:600}"> <div class="elementor-element elementor-element-b1723f0 elementor-view-default elementor-widget elementor-widget-icon" data-id="b1723f0" data-element_type="widget" data-widget_type="icon.default"> <div class="elementor-widget-container"> <div class="elementor-icon-wrapper"> <div class="elementor-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-people-arrows" viewBox="0 0 576 512" xmlns="http://www.w3.org/2000/svg"><path d="M96,128A64,64,0,1,0,32,64,64,64,0,0,0,96,128Zm0,176.08a44.11,44.11,0,0,1,13.64-32L181.77,204c1.65-1.55,3.77-2.31,5.61-3.57A63.91,63.91,0,0,0,128,160H64A64,64,0,0,0,0,224v96a32,32,0,0,0,32,32V480a32,32,0,0,0,32,32h64a32,32,0,0,0,32-32V383.61l-50.36-47.53A44.08,44.08,0,0,1,96,304.08ZM480,128a64,64,0,1,0-64-64A64,64,0,0,0,480,128Zm32,32H448a63.91,63.91,0,0,0-59.38,40.42c1.84,1.27,4,2,5.62,3.59l72.12,68.06a44.37,44.37,0,0,1,0,64L416,383.62V480a32,32,0,0,0,32,32h64a32,32,0,0,0,32-32V352a32,32,0,0,0,32-32V224A64,64,0,0,0,512,160ZM444.4,295.34l-72.12-68.06A12,12,0,0,0,352,236v36H224V236a12,12,0,0,0-20.28-8.73L131.6,295.34a12.4,12.4,0,0,0,0,17.47l72.12,68.07A12,12,0,0,0,224,372.14V336H352v36.14a12,12,0,0,0,20.28,8.74l72.12-68.07A12.4,12.4,0,0,0,444.4,295.34Z"></path></svg> </div> </div> </div> </div> <div class="elementor-element elementor-element-7d4251c elementor-widget elementor-widget-heading" data-id="7d4251c" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h3 class="elementor-heading-title elementor-size-default">Études cliniques </h3> </div> </div> <div class="elementor-element elementor-element-dcabf6a elementor-widget elementor-widget-text-editor" data-id="dcabf6a" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Participation, en concertation avec le client, au suivi des études cliniques pour évaluer les performances du kit IVD, notamment sa sensibilité, sa spécificité et sa précision dans le diagnostic des maladies ou des conditions médicales cibles.</p> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-86a8c4b e-flex e-con-boxed e-con e-parent" data-id="86a8c4b" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-7c0fba7 e-con-full animated-slow e-flex elementor-invisible e-con e-child" data-id="7c0fba7" data-element_type="container" data-settings="{&quot;animation&quot;:&quot;fadeIn&quot;,&quot;animation_delay&quot;:200}"> <div class="elementor-element elementor-element-dad5e04 elementor-view-default elementor-widget elementor-widget-icon" data-id="dad5e04" data-element_type="widget" data-widget_type="icon.default"> <div class="elementor-widget-container"> <div class="elementor-icon-wrapper"> <div class="elementor-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-tag" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M0 252.118V48C0 21.49 21.49 0 48 0h204.118a48 48 0 0 1 33.941 14.059l211.882 211.882c18.745 18.745 18.745 49.137 0 67.882L293.823 497.941c-18.745 18.745-49.137 18.745-67.882 0L14.059 286.059A48 48 0 0 1 0 252.118zM112 64c-26.51 0-48 21.49-48 48s21.49 48 48 48 48-21.49 48-48-21.49-48-48-48z"></path></svg> </div> </div> </div> </div> <div class="elementor-element elementor-element-7347e7a elementor-widget elementor-widget-heading" data-id="7347e7a" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h3 class="elementor-heading-title elementor-size-default">Étiquetage et documentation </h3> </div> </div> <div class="elementor-element elementor-element-0ed46d4 elementor-widget elementor-widget-text-editor" data-id="0ed46d4" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Élaborer un étiquetage complet et des documents d&rsquo;accompagnement, y compris les instructions d&rsquo;utilisation, les mises en garde, les précautions et les contre-indications, conformément aux exigences réglementaires.</p> </div> </div> </div> <div class="elementor-element elementor-element-1c5862c e-con-full animated-slow e-flex elementor-invisible e-con e-child" data-id="1c5862c" data-element_type="container" data-settings="{&quot;animation&quot;:&quot;fadeIn&quot;,&quot;animation_delay&quot;:300}"> <div class="elementor-element elementor-element-9715510 elementor-view-default elementor-widget elementor-widget-icon" data-id="9715510" data-element_type="widget" data-widget_type="icon.default"> <div class="elementor-widget-container"> <div class="elementor-icon-wrapper"> <div class="elementor-icon"> <svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 64 64"><path d="m54.029 24.157c0-12.216-9.913-22.029-22.029-22.029s-22.029 9.913-22.029 22.029c0 8.411 5.107 15.821 12.016 19.525l-2.003 18.524 12.016-8.01 12.016 8.01-2.003-18.524c7.009-3.705 12.016-11.114 12.016-19.525zm-22.029 20.026c-11.114 0-20.026-9.012-20.026-20.026 0-11.114 9.012-20.026 20.026-20.026s20.026 9.012 20.026 20.026a19.957 19.957 0 0 1 -20.026 20.026zm9.012-28.237 3.004 3.004-13.518 13.518-7.51-7.51 3.004-3.004 4.506 4.506z"></path></svg> </div> </div> </div> </div> <div class="elementor-element elementor-element-50c40fb elementor-widget elementor-widget-heading" data-id="50c40fb" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h3 class="elementor-heading-title elementor-size-default">Vérification de la qualité </h3> </div> </div> <div class="elementor-element elementor-element-90e2c2a elementor-widget elementor-widget-text-editor" data-id="90e2c2a" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Mettre en place des systèmes de contrôle qualité pour surveiller la fabrication du kit IVD, s&rsquo;assurer de la conformité aux spécifications et détecter les éventuels problèmes de qualité.</p> </div> </div> </div> <div class="elementor-element elementor-element-b7b8f8e e-con-full animated-slow e-flex elementor-invisible e-con e-child" data-id="b7b8f8e" data-element_type="container" data-settings="{&quot;animation&quot;:&quot;fadeIn&quot;,&quot;animation_delay&quot;:500}"> <div class="elementor-element elementor-element-6aafac9 elementor-view-default elementor-widget elementor-widget-icon" data-id="6aafac9" data-element_type="widget" data-widget_type="icon.default"> <div class="elementor-widget-container"> <div class="elementor-icon-wrapper"> <div class="elementor-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-far-edit" viewBox="0 0 576 512" xmlns="http://www.w3.org/2000/svg"><path d="M402.3 344.9l32-32c5-5 13.7-1.5 13.7 5.7V464c0 26.5-21.5 48-48 48H48c-26.5 0-48-21.5-48-48V112c0-26.5 21.5-48 48-48h273.5c7.1 0 10.7 8.6 5.7 13.7l-32 32c-1.5 1.5-3.5 2.3-5.7 2.3H48v352h352V350.5c0-2.1.8-4.1 2.3-5.6zm156.6-201.8L296.3 405.7l-90.4 10c-26.2 2.9-48.5-19.2-45.6-45.6l10-90.4L432.9 17.1c22.9-22.9 59.9-22.9 82.7 0l43.2 43.2c22.9 22.9 22.9 60 .1 82.8zM460.1 174L402 115.9 216.2 301.8l-7.3 65.3 65.3-7.3L460.1 174zm64.8-79.7l-43.2-43.2c-4.1-4.1-10.8-4.1-14.8 0L436 82l58.1 58.1 30.9-30.9c4-4.2 4-10.8-.1-14.9z"></path></svg> </div> </div> </div> </div> <div class="elementor-element elementor-element-97c8a69 elementor-widget elementor-widget-heading" data-id="97c8a69" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h3 class="elementor-heading-title elementor-size-default">Gestion des changements </h3> </div> </div> <div class="elementor-element elementor-element-4eb21f6 elementor-widget elementor-widget-text-editor" data-id="4eb21f6" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Gérer les modifications apportées au kit IVD tout au long de son cycle de vie, en s&rsquo;assurant que ces changements sont documentés, évalués pour leur impact réglementaire et mis en œuvre de manière appropriée.</p> </div> </div> </div> <div class="elementor-element elementor-element-dce5360 e-con-full animated-slow e-flex elementor-invisible e-con e-child" data-id="dce5360" data-element_type="container" data-settings="{&quot;animation&quot;:&quot;fadeIn&quot;,&quot;animation_delay&quot;:600}"> <div class="elementor-element elementor-element-9d4b521 elementor-view-default elementor-widget elementor-widget-icon" data-id="9d4b521" data-element_type="widget" data-widget_type="icon.default"> <div class="elementor-widget-container"> <div class="elementor-icon-wrapper"> <div class="elementor-icon"> <svg aria-hidden="true" class="e-font-icon-svg e-fas-sync-alt" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M370.72 133.28C339.458 104.008 298.888 87.962 255.848 88c-77.458.068-144.328 53.178-162.791 126.85-1.344 5.363-6.122 9.15-11.651 9.15H24.103c-7.498 0-13.194-6.807-11.807-14.176C33.933 94.924 134.813 8 256 8c66.448 0 126.791 26.136 171.315 68.685L463.03 40.97C478.149 25.851 504 36.559 504 57.941V192c0 13.255-10.745 24-24 24H345.941c-21.382 0-32.09-25.851-16.971-40.971l41.75-41.749zM32 296h134.059c21.382 0 32.09 25.851 16.971 40.971l-41.75 41.75c31.262 29.273 71.835 45.319 114.876 45.28 77.418-.07 144.315-53.144 162.787-126.849 1.344-5.363 6.122-9.15 11.651-9.15h57.304c7.498 0 13.194 6.807 11.807 14.176C478.067 417.076 377.187 504 256 504c-66.448 0-126.791-26.136-171.315-68.685L48.97 471.03C33.851 486.149 8 475.441 8 454.059V320c0-13.255 10.745-24 24-24z"></path></svg> </div> </div> </div> </div> <div class="elementor-element elementor-element-20f2c6c elementor-widget elementor-widget-heading" data-id="20f2c6c" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h3 class="elementor-heading-title elementor-size-default">Communication avec les autorités réglementaires </h3> </div> </div> <div class="elementor-element elementor-element-cfaee85 elementor-widget elementor-widget-text-editor" data-id="cfaee85" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Interagir avec les autorités réglementaires compétentes pour obtenir les approbations nécessaires et maintenir une communication transparente sur les aspects réglementaires du kit IVD.</p> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-5a8eb9d e-con-full e-flex e-con e-parent" data-id="5a8eb9d" data-element_type="container" data-settings="{&quot;background_background&quot;:&quot;classic&quot;}"> <div class="elementor-element elementor-element-ad9c552 e-flex e-con-boxed e-con e-child" data-id="ad9c552" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-e8510e3 elementor-invisible elementor-widget elementor-widget-text-editor" data-id="e8510e3" data-element_type="widget" data-settings="{&quot;_animation&quot;:&quot;fadeIn&quot;,&quot;_animation_delay&quot;:300}" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Ces services garantissent que votre kit de DIV est conforme aux normes réglementaires, qu&rsquo;il fonctionne efficacement et qu&rsquo;il est mis sur le marché avec fiabilité et respect des réglementations.</p> </div> </div> </div> </div> </div> <div class="elementor-element elementor-element-f03dba6 e-flex e-con-boxed e-con e-parent" data-id="f03dba6" data-element_type="container" data-settings="{&quot;background_background&quot;:&quot;classic&quot;}"> <div class="e-con-inner"> <div class="elementor-element elementor-element-1f382e8 elementor-widget elementor-widget-heading" data-id="1f382e8" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default"><a href="https://firalismolecularprecision.com/fr/nous-contacter/">Si vous souhaitez bénéficier du soutien et de l'expertise de notre équipe réglementaire pour la mise sur le marché de votre kit de diagnostic</a></h2> </div> </div> <div class="elementor-element elementor-element-bff5caa elementor-button-info elementor-align-center elementor-widget elementor-widget-button" data-id="bff5caa" data-element_type="widget" data-widget_type="button.default"> <div class="elementor-widget-container"> <div class="elementor-button-wrapper"> <a 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