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Certificación ISO 13485 para dispositivos médicos | LRQA MX

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breadcrumbsCurrent"> ISO 13485 </strong> </li> </ol> </nav> <img src="/static/assets/search-grey.svg" loading="eager" style="display:none;" /> <main id="content" tabindex="-1"> <section class="grid headerContentArea" > <div class="hero heroVariant2 heroAlignCentre canvas canvasNavy col-12" id="H1&#x2B;-&#x2B;ISO&#x2B;13485&#x2B;Medical&#x2B;Quality&#x2B;Management&#x2B;System"> <div class="image" > <picture><source srcset="/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 1024w,/cdn-cgi/image/width=1280,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg 1280w,/cdn-cgi/image/width=1440,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg 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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" > Cumplir con los requisitos de la industria de dispositivos m&#xE9;dicos. </h1> <p class="heroSummary" > ISO 13485 proporciona un marco completo para que los fabricantes de dispositivos m&#xE9;dicos aseguren la calidad del producto y el cumplimiento de las normas. </p> <p class="heroSubtitle" > ISO 13485 Dispositivos M&#xE9;dicos </p> <ul class="heroList" > <li class="heroListItem"> <a href="/es-mx/iso-13485/certificacion/" class="arrowLink arrowLinkBold">Servicios ISO 13485</a> </li> </ul> </div> </div><div class="stickyCtaContainer twoItems" id="Shared&#x2B;Sticky&#x2B;CTA&#x2B;-&#x2B;MX&#x2B;BA"> <a href="tel: &#x2B;52 (81) 8152 1000" class="stickyCtaButton" > <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-phoneRinging"></use> </svg> </span> <span class="text"> &#x2B;52 (81) 8152 1000 </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"> Solicitar presupuesto </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">Solicitar presupuesto</h3> <div class="stickyCtaDialogIframeContainer"> <iframe class="stickyCtaDialogIframe" src="https://info.lrqa.com/l/12702/2021-10-03/c3jcs8?" 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&#x2B;13485&#x2B;Page&#x2B;Tabs"> <div class="swipeNav col-12"> <div class="swipeNavWrap"> <ul class="swipeNavList" > <li class="swipeNavListItem"> <a href="/es-mx/iso-13485/" class="swipeNavLink cta ctaTertiary"> <span class="text"> ISO 13485 </span> </a> </li> <li class="swipeNavListItem"> <a href="/es-mx/iso-13485/certificacion/" class="swipeNavLink cta ctaTertiary"> <span class="text"> Servicios de Certificaci&#xF3;n </span> </a> </li> <li class="swipeNavListItem"> <a href="/es-mx/iso-13485/capacitacion/" class="swipeNavLink cta ctaTertiary"> <span class="text"> Capacitaci&#xF3;n </span> </a> </li> <li class="swipeNavListItem"> <a href="/es-mx/iso-13485/descargas/" class="swipeNavLink cta ctaTertiary"> <span class="text"> Descargas </span> </a> </li> </ul> </div> </div> </div><div class="textBlock col-12 spacingSmall" id="Body&#x2B;main&#x2B;-&#x2B;ISO&#x2B;13485&#x2B;Medical&#x2B;Quality&#x2B;Management&#x2B;System&#x2B;Overview"> <div class="wysiwyg" > <h4>Resumen</h4><p>En el mundo altamente regulado de la fabricaci贸n de dispositivos m茅dicos, las organizaciones tienen el deber de demostrar que cada dispositivo cumple tanto con las expectativas del cliente como con la normativa aplicable. LRQA apoya a sus clientes en sus esfuerzos por cumplir con los estrictos requisitos de la norma ISO 13485, afinando los ciclos de vida de desarrollo de productos para asegurar un lanzamiento a tiempo al mercado.</p> <p>La norma internacional del sistema de gesti贸n de calidad (SGC) para dispositivos m茅dicos, ISO 13485:2016 (Dispositivos m茅dicos - Sistemas de gesti贸n de calidad - Requisitos para fines reglamentarios) se public贸 el 1 de marzo de 2016, y el Foro Internacional de Acreditaci贸n (IAF, por sus siglas en ingl茅s) concedi贸 a las organizaciones certificadas un plazo de tres a帽os de transici贸n con respecto a las versiones anteriores. La norma ISO 13485:2012 mantiene su condici贸n de norma armonizada y la presunci贸n de conformidad hasta el final del per铆odo transitorio.</p> <p>La norma ISO 13485:2016 introduce una serie de cambios sutiles, aunque detallados, que requieren una documentaci贸n m谩s completa sobre el entorno de trabajo, la gesti贸n de riesgos, el control del dise帽o y los requisitos reglamentarios. La norma revisada incluye la necesidad de un enfoque del sistema de gesti贸n de la calidad basado en el riesgo, una mayor atenci贸n a los requisitos normativos y a las responsabilidades de la alta direcci贸n, un mayor control sobre los proveedores y las actividades subcontratadas, y un 茅nfasis en la gesti贸n de riesgos a lo largo del ciclo de vida del producto.</p> <p>ISO 13485 se aplica tanto a los fabricantes de dispositivos m茅dicos como a las organizaciones que apoyan a los fabricantes de dispositivos m茅dicos. Respalda el deber de los fabricantes de garantizar que los dispositivos cumplan de forma coherente con los requisitos de los clientes y los requisitos reglamentarios aplicables.</p> <p>La ISO 13485:2016 actualizada sustituye a todas las versiones anteriores en marzo de 2019.&nbsp;</p> </div></div><div class="textBlock col-12 spacingSmall" id="Body&#x2B;main&#x2B;-&#x2B;Benefits&#x2B;of&#x2B;ISO&#x2B;13485"> <div class="wysiwyg" > <h4>Beneficios de la ISO 13485</h4><h4>Libertad de comercio</h4> <p>Muchos fabricantes exigen que los proveedores cuenten con la certificaci贸n ISO 13485, por lo que la norma es un requisito previo para seguir siendo competitivos.</p> <h4>Calidad constante</h4> <p>La seguridad del paciente depende de la calidad de los productos m茅dicos. La certificaci贸n ISO 13485 ofrece a los fabricantes la confianza de que las organizaciones a lo largo de la cadena de suministro pueden lograr y mantener el cumplimiento.</p> <h4>Gesti贸n de riesgos</h4> <p>Obtener la certificaci贸n ISO 13485 es un m茅todo proactivo para prevenir incidentes y priorizar la seguridad del paciente. Esto ayuda a minimizar el riesgo de da帽os a la reputaci贸n de los fabricantes causados por defectos del producto.</p> </div></div><div class="textBlock col-12 spacingSmall" id="Body&#x2B;main&#x2B;-&#x2B;Need&#x2B;help&#x2B;with&#x2B;ISO&#x2B;13485%3f"> <div class="wysiwyg" > <h4>驴Necesita ayuda con ISO 13485?</h4><p>Como norma reconocida internacionalmente en el mundo de la fabricaci贸n de dispositivos m茅dicos, la ISO 13485 le ayuda a superar a la competencia minimizando los riesgos a lo largo del ciclo de vida de desarrollo de su producto.</p> <p>Gracias al enfoque sistem谩tico de LRQA, usted recibir谩 el apoyo adecuado en cada etapa del desarrollo del producto, lo que le permitir谩 lanzarlo al mercado en el momento oportuno.</p> <p>LRQA ofrece una amplia gama de servicios ISO 13485, incluyendo certificaci贸n, an谩lisis de deficiencias y capacitaci贸n, todos ellos dise帽ados para ayudarle <a href="/es-mx/iso-13485/certificacion/?epslanguage=es-MX">en </a>, <a href="/es-mx/iso-13485/certificacion/?epslanguage=es-MX">su </a>camino hacia la conformidad satisfactoria.</p> </div></div><div class="textBlock col-12 spacingSmall" id="Body&#x2B;main&#x2B;-&#x2B;ISO&#x2B;13485&#x2B;Why&#x2B;work&#x2B;with&#x2B;us%3f"> <div class="wysiwyg" > <h4>驴Por qu茅 trabajar con nosotros?</h4><h4>Dedicaci&oacute;n a la seguridad</h4> <p>LRQA explora cada proceso del sistema de gesti&oacute;n de calidad con rigurosa precisi&oacute;n anal&iacute;tica para extraer conclusiones precisas cada vez.</p> <h4>Experiencia t&eacute;cnica</h4> <p>LRQA est&aacute; acreditada por el United Kingdom Accreditation Service (UKAS) y el Standards Council of Canada (SCC) para proporcionar la certificaci&oacute;n ISO 13485:2016, y tambi&eacute;n somos una Organizaci&oacute;n de Auditor&iacute;a Autorizada bajo el programa MDSAP. Nuestros asesores son especialistas de la industria a quienes adaptamos a las necesidades de su negocio, lo que permite una auditor&iacute;a efectiva de su sistema de control de calidad que genera impactos positivos a corto y largo plazo.</p> </div></div> </section> <section class="grid bottomContent" > <div class="textBlock col-12" id="S02.18&#x2B;Management&#x2B;Systems&#x2B;request&#x2B;for&#x2B;information&#x2B;about&#x2B;service"> <div class="wysiwyg" > <h4 style="text-align: center;">驴Desea saber m谩s sobre este servicio?</h4><p style="text-align: center;"><a href="https://info.lrqa.com/l/12702/2022-02-24/csdf4t?website_url=&website_sector=" class="cta">Datos de contacto</a></p> </div></div><div class="carouselBlock canvas canvasWhite col-12" id="S03.02&#x2B;Generic&#x2B;case&#x2B;study"> </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"> <li class="socialListItem"> <a href="https://x.com/lrqa" class="socialListItemLink" rel="noopener"> <img decoding="auto" fetchpriority="auto" src="/cdn-cgi/image/width=20,format=auto/globalassets/_shared-images/twitter2.png" srcset="/cdn-cgi/image/width=20,format=auto/globalassets/_shared-images/twitter2.png 20w,/cdn-cgi/image/width=40,format=auto/globalassets/_shared-images/twitter2.png 40w,/cdn-cgi/image/width=60,format=auto/globalassets/_shared-images/twitter2.png 60w" sizes="20px" alt="" loading="lazy" class="" width="21" height="22" /> </a> </li> <li class="socialListItem"> <a href="https://www.linkedin.com/company/lrqa/" class="socialListItemLink" rel="noopener"> <img decoding="auto" fetchpriority="auto" src="/cdn-cgi/image/width=20,format=auto/globalassets/_shared-images/linkedin-icon-1.png" srcset="/cdn-cgi/image/width=20,format=auto/globalassets/_shared-images/linkedin-icon-1.png 20w,/cdn-cgi/image/width=40,format=auto/globalassets/_shared-images/linkedin-icon-1.png 40w,/cdn-cgi/image/width=60,format=auto/globalassets/_shared-images/linkedin-icon-1.png 60w" sizes="20px" alt="LinkedIn icon in mint green" loading="lazy" class="" width="134" height="134" /> </a> </li> </ul> </div> <ul class="footerList"> <li class="footerListItem"> <a href="/es-mx/quienes-somos/" class="footerListItemLink">Qui&#xE9;nes somos</a> </li> <li class="footerListItem"> <a href="/es-mx/carreras/" class="footerListItemLink">Carreras</a> </li> <li class="footerListItem"> <a href="/es-mx/descargas/" class="footerListItemLink">Recursos</a> </li> </ul> <div class="wysiwyg"> <p style="text-align: center;">LRQA and any variants are trading names of LRQA Group Limited, its subsidiaries and affiliates. 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