Certification ISO 13485 pour les dispositifs médicaux

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1920w,/cdn-cgi/image/width=2048,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 2048w,/cdn-cgi/image/width=2304,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 2304w,/cdn-cgi/image/width=2560,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 2560w,/cdn-cgi/image/width=2880,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 2880w,/cdn-cgi/image/width=3072,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 3072w,/cdn-cgi/image/width=3840,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 3840w,/cdn-cgi/image/width=4320,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 4320w,/cdn-cgi/image/width=5760,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 5760w" sizes="100vw" media="" ><img src="/cdn-cgi/image/width=1024,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg" alt="Stethoscope on tablet" loading="eager" decoding="auto" fetchpriority="auto" class="heroImage" fetchpriority="auto" ></picture> </div> <div class="titleBlock"> <h1 class="heroTitle" > Services d’évaluation d’analyse d’écarts et de certification ISO 13485 </h1> <p class="heroSummary" > Garantir la qualité grâce à la formation et à la certification du SMQ des dispositifs médicaux </p> <ul class="heroList" > <li class="heroListItem"> <a href="/fr-be/iso-13485/#request-quote" class="arrowLink arrowLinkBold">Demander un devis</a> </li> <li class="heroListItem"> <a href="/fr-be/iso-13485/#transfer-to-lrqa" class="arrowLink arrowLinkBold">Transfert vers LRQA</a> </li> </ul> </div> </div><div class="stickyCtaContainer twoItems" id="BE-BA+French+Shared+global+sticky+CTA+-+BA"> <a href="tel:+32 33 752 970" class="stickyCtaButton" > <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-phoneRinging"></use> </svg> </span> <span class="text"> +32 33 752 970 </span> </a> <button type="button" class="stickyCtaButton modalButton" data-dialog="modal2" > <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-letter"></use> </svg> </span> <span class="text"> Nous contacter </span> </button> <dialog id="modal2"> <div class="dialogWrap"> <button type="button" class="innerDialogButton"> <svg focusable="false" class="white"> <title>Close</title> <use href="/static/images/svg.svg#svg-close"></use> </svg> </button> <div class="dialogWrapInner"> <div class="stickyCtaDialog white"> <div class="stickyCtaDialogContent"> <h3 class="stickyCtaDialogHeader">Nous contacter</h3> <div class="stickyCtaDialogIframeContainer"> <iframe class="stickyCtaDialogIframe" src="https://info.lrqa.com/l/12702/2022-11-17/g8w3pt?" loading="lazy" id="iFrameResizer2" style="overflow: hidden;" scrolling="no"> </iframe> </div> </div> </div> </div> </div> </dialog> </div> </section> <section class="grid stickyContentArea" > </section> <section class="grid mainContent" > <div class="quickLinks col-12 spacingSmall canvas canvasNavy" id="ISO+13485+Page+Tabs"> <div class="swipeNav col-12"> <div class="swipeNavWrap"> <ul class="swipeNavList" > <li class="swipeNavListItem"> <a href="/fr-be/iso-13485/formations/" class="swipeNavLink cta ctaTertiary"> <span class="text"> Formation </span> </a> </li> </ul> </div> </div> </div><div class="textBlock col-12 spacingSmall" id="Body+main+-+ISO+13485+Medical+Quality+Management+System+Overview"> <div class="wysiwyg" > <h4>Aper莽u</h4><p>Dans l’univers très régulé de la production de dispositifs médicaux, les organisations ont le devoir de démontrer que chaque dispositif satisfait tant aux attentes des clients qu’aux réglementations applicables. LRQA assiste ses clients dans leurs efforts pour répondre aux exigences strictes de la <a href="/fr-be/iso-13485/?epslanguage=fr-BE">norme ISO 13485</a>, en peaufinant les différents stades de développement de produits pour assurer une mise sur le marché dans les temps.</p> <p>La norme internationale relative aux systèmes de management de la qualité (SMQ) portant sur les dispositifs médicaux, ISO 13485:2016 (Dispositifs médicaux — Systèmes de management de la qualité — Exigences à des fins réglementaires) a été publiée le 1er mars 2016. L’International Accreditation Forum (IAF) a accordé aux organisations certifiées un délai de trois ans pour achever leur transition depuis les versions précédentes. La norme ISO 13485:2012 reste en vigueur en tant que norme harmonisée et la présomption de conformité est maintenue jusqu’à la fin de la période de transition.</p> <p>ISO 13485:2016 introduit toutes sortes de modifications subtiles, mais détaillées, nécessitant une documentation plus complète sur l’environnement de travail, la gestion des risques, le contrôle de la conception et les exigences réglementaires. La norme révisée ajoute la nécessité d’une approche du SMQ fondée sur le risque, une attention accrue portée sur les exigences réglementaires et les responsabilités de la direction, des contrôles renforcés des fournisseurs et des activités d’externalisation, et sur la gestion des risques durant le cycle de vie des produits.</p> <p>La norme ISO 13485 s’applique tant aux fabricants de dispositifs médicaux qu’aux organisations qui appuient ces fabricants. Elle met en exergue le devoir des fabricants de s’assurer que les dispositifs satisfont constamment aux exigences clients et réglementaires applicables.</p> <p>La norme révisée ISO 13485:2016 remplacera toutes les versions précédentes en mars 2019. </p> </div></div><div class="textBlock col-12 spacingSmall" id="Body+main+-+Benefits+of+ISO+13485"> <div class="wysiwyg" > <h4>Avantages de la norme ISO 13485</h4><h4>Libert茅 des 茅changes</h4> <p>De nombreux fabricants exigent que leurs fournisseurs soient certifi茅s ISO 13485, de sorte que la norme devient un pr茅requis pour rester dans la course.</p> <h4>Qualit茅 constante</h4> <p>La s茅curit茅 des patients d茅pend de la qualit茅 des produits m茅dicaux. Gr芒ce 脿 la certification ISO 13485, les fabricants se fient aux organisations qui sont en mesure d鈥檃tteindre et de maintenir la conformit茅 sur toute la cha卯ne logistique.</p> <h4>Gestion des risques</h4> <p>L鈥檕btention de la certification ISO 13485 est un moyen de pr茅venir proactivement les incidents et de donner la priorit茅脿 la s茅curit茅 des patients. Le risque que les fabricants nuisent 脿 leur r茅putation 脿 cause de produits d茅fectueux est ainsi minimis茅.</p> </div></div><div class="textBlock col-12 spacingSmall" id="Body+main+-+Need+help+with+ISO+13485%3f"> <div class="wysiwyg" > <h4>Besoin d鈥檃ide avec l鈥橧SO 13485聽?</h4><p>La norme ISO 13485, internationalement reconnue dans l’univers de la fabrication de dispositifs médicaux, vous aide à vous démarquer de la concurrence en minimisant les risques à tous les stades du développement de votre produit.</p> <p>Grâce à l’approche systématique de LRQA, vous bénéficierez de l’assistance adéquate à chaque étape du développement du produit afin de faciliter une mise sur le marché dans les temps.</p> <p>LRQA fournit un vaste éventail de services ISO 13485, notamment la <a href="/fr-be/iso-13485/certification/?epslanguage=fr-BE">certification</a>, l’<a href="/fr-be/iso-13485/certification/?epslanguage=fr-BE">analyse des écarts</a> et la formation, le tout étant conçu pour vous accompagner dans votre parcours aboutissant à une conformité aboutie.</p> <p><a title="Contactez-nous pour en savoir plus sur nos services de certification et formation ISO 13485." href="/fr-be/demande-information/?epslanguage=fr-BE">Contactez-nous pour en savoir plus sur nos services de certification et formation ISO 13485.</a></p> </div></div><div class="textBlock col-12 spacingSmall" id="Body+main+-+ISO+13485+Why+work+with+us%3f"> <div class="wysiwyg" > <h4>Pourquoi choisir LR聽?</h4><h4>Attachement à la certification</h4> <p>LRQA inspecte chaque processus du système de management de la qualité de manière méticuleuse avec une précision analytique afin de systématiquement tirer des conclusions précises.</p> <h4>Expertise technique</h4> <p>LRQA est accréditée par le service d’accréditation du Royaume-Uni, UKAS et le Conseil canadien des normes (CCN) pour la certification ISO 13485:2016, et est également un organisme d’audit homologué dans le cadre du programme MDSAP. Nos auditeurs sont des spécialistes du secteur, que nous trions sur le volet en fonction des besoins de votre entreprise, pour un audit efficace de votre SMQ produisant des effets positifs à court et long termes.</p> </div></div> </section> <section class="grid bottomContent" > <div class="carouselBlock canvas canvasWhite col-12" id="S03.02+Generic+case+study"> </div><div class="carouselBlock canvas canvasNavy col-12 spacingLarge" id="S03.01+Generic+insights+carousel+(2)"> </div><div class="carouselBlock canvas canvasWhite col-12 spacingSmall" id="S03.03+Generic+events+list"> </div> </section> </main> <footer class="footer canvas canvasNavy"> <div class="footerLogo"> <img decoding="auto" fetchpriority="auto" class="" src="/cdn-cgi/image/width=120,format=auto/globalassets/logos/lrqa-white-logo---dark-background-cropped.png" srcset="/cdn-cgi/image/width=120,format=auto/globalassets/logos/lrqa-white-logo---dark-background-cropped.png 120w,/cdn-cgi/image/width=150,format=auto/globalassets/logos/lrqa-white-logo---dark-background-cropped.png 150w,/cdn-cgi/image/width=240,format=auto/globalassets/logos/lrqa-white-logo---dark-background-cropped.png 240w,/cdn-cgi/image/width=300,format=auto/globalassets/logos/lrqa-white-logo---dark-background-cropped.png 300w,/cdn-cgi/image/width=360,format=auto/globalassets/logos/lrqa-white-logo---dark-background-cropped.png 360w,/cdn-cgi/image/width=450,format=auto/globalassets/logos/lrqa-white-logo---dark-background-cropped.png 450w" sizes="(min-width: 1280px) 150px, 120px" alt="" loading="lazy" width="500" height="174" /> <ul class="socialList"> </ul> </div> <ul class="footerList"> <li class="footerListItem"> <a href="/fr-be/a-propos/" class="footerListItemLink">À propos de LRQA</a> </li> <li class="footerListItem"> <a href="/en/careers/" class="footerListItemLink">Offres d’emploi</a> </li> <li class="footerListItem"> <a href="/fr-be/ressources/" class="footerListItemLink">Documentation</a> </li> </ul> <div class="wysiwyg"> <p style="text-align: center;"><span>LRQA and any variants are trading names of LRQA Group Limited, its subsidiaries and affiliates. 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Certification ISO 13485 pour les dispositifs médicaux