Certificación ISO 13485 para dispositivos médicos

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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" > Cumplir con los requisitos de la industria de dispositivos médicos. </h1> <p class="heroSummary" > ISO 13485 proporciona un marco completo para que los fabricantes de dispositivos médicos aseguren la calidad del producto y el cumplimiento de las normas. </p> <p class="heroSubtitle" > ISO 13485 Dispositivos Médicos </p> <ul class="heroList" > <li class="heroListItem"> <a href="/es-cl/iso-13485/certificacion/" class="arrowLink arrowLinkBold">Servicios ISO 13485</a> </li> </ul> </div> </div><div class="stickyCtaContainer twoItems" id="CL-BA+Service+Contact+Bar"> <a href="tel:+56 9 97192380" class="stickyCtaButton" > <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-phoneRinging"></use> </svg> </span> <span class="text"> +56 9 97192380 </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"> Contáctenos </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">Contáctenos</h3> <div class="stickyCtaDialogIframeContainer"> <iframe class="stickyCtaDialogIframe" src="https://info.lrqa.com/l/12702/2021-10-05/c4ddbv?" 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="/es-cl/iso-13485/" class="swipeNavLink cta ctaTertiary"> <span class="text"> ISO 13485 </span> </a> </li> <li class="swipeNavListItem"> <a href="/es-cl/iso-13485/certificacion/" class="swipeNavLink cta ctaTertiary"> <span class="text"> Servicios de Certificación </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>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. </p> </div></div><div class="textBlock col-12 spacingSmall" id="Body+main+-+Benefits+of+ISO+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+main+-+Need+help+with+ISO+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-cl/iso-13485/certificacion/?epslanguage=es-CL">en </a>, <a href="/es-cl/iso-13485/certificacion/?epslanguage=es-CL">su </a>camino hacia la conformidad satisfactoria.</p> </div></div><div class="textBlock col-12 spacingSmall" id="Body+main+-+ISO+13485+Why+work+with+us%3f"> <div class="wysiwyg" > <h4>驴Por qu茅 trabajar con nosotros?</h4><h4>Dedicación a la seguridad</h4> <p>LRQA explora cada proceso del sistema de gestión de calidad con rigurosa precisión analítica para extraer conclusiones precisas cada vez.</p> <h4>Experiencia técnica</h4> <p>LRQA está acreditada por el United Kingdom Accreditation Service (UKAS) y el Standards Council of Canada (SCC) para proporcionar la certificación ISO 13485:2016, y también somos una Organización de Auditoría 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 auditoría 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+Management+Systems+request+for+information+about+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/12702/2021-10-05/c4ddbv?website_url=&website_sector=" class="cta">Cont谩ctenos</a></p> </div></div><div class="carouselBlock canvas canvasWhite col-12" id="S03.02+Generic+case+study"> <h2 class="carouselBlockHeading" > <strong>CASOS DE INTERÉS</strong> </h2> <div class="carousel"> <div class="carouselContent"> <ul class="carouselContentList"> <li> <div class="imageTextWrap themeMint"> <div class="imageText"> <h3 class="imageTextTitle"> ISO 27001: ClarkeModet </h3> <div class="imageTextImgWrap"> <img src="/cdn-cgi/image/width=432,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg" srcset="/cdn-cgi/image/width=210,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 210w,/cdn-cgi/image/width=280,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 280w,/cdn-cgi/image/width=324,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 324w,/cdn-cgi/image/width=335,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 335w,/cdn-cgi/image/width=420,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 420w,/cdn-cgi/image/width=432,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 432w,/cdn-cgi/image/width=526,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 526w,/cdn-cgi/image/width=560,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 560w,/cdn-cgi/image/width=560,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 560w,/cdn-cgi/image/width=606,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 606w,/cdn-cgi/image/width=630,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 630w,/cdn-cgi/image/width=648,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 648w,/cdn-cgi/image/width=670,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 670w,/cdn-cgi/image/width=776,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 776w,/cdn-cgi/image/width=840,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 840w,/cdn-cgi/image/width=864,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 864w,/cdn-cgi/image/width=972,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 972w,/cdn-cgi/image/width=1005,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 1005w,/cdn-cgi/image/width=1052,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 1052w,/cdn-cgi/image/width=1052,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 1052w,/cdn-cgi/image/width=1164,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 1164w,/cdn-cgi/image/width=1212,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 1212w,/cdn-cgi/image/width=1296,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 1296w,/cdn-cgi/image/width=1578,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 1578w,/cdn-cgi/image/width=1818,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 1818w" alt="Servers" loading="lazy" decoding="auto" fetchpriority="auto" width="532" height="421" class="imageTextImg"> </div> <p class="promoBlockLabel imageTextLabel"> Caso de estudio </p> <p class="imageTextSummary"> LRQA ha certificado, bajo la norma internacional ISO/IEC 27001:2013, el Sistema de Gestión de la Información de ClarkeModet,... </p> <a href="/es-cl/casos-practicos/clarke-modet/" class="imageTextLink arrowLink arrowLinkBold"> </a> </div> </div> </li> <li> <div class="imageTextWrap themeMint"> <div class="imageText"> <h3 class="imageTextTitle"> Starbucks China obtiene la certificación FSSC 22000 con LRQA </h3> <div class="imageTextImgWrap"> <img src="/cdn-cgi/image/width=432,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/food/532-x-421-coffee-beans.png" srcset="/cdn-cgi/image/width=210,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/food/532-x-421-coffee-beans.png 210w,/cdn-cgi/image/width=280,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/food/532-x-421-coffee-beans.png 280w,/cdn-cgi/image/width=324,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/food/532-x-421-coffee-beans.png 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1005w,/cdn-cgi/image/width=1052,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/health-safety/531x421-airport.jpg 1052w,/cdn-cgi/image/width=1052,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/health-safety/531x421-airport.jpg 1052w,/cdn-cgi/image/width=1164,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/health-safety/531x421-airport.jpg 1164w,/cdn-cgi/image/width=1212,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/health-safety/531x421-airport.jpg 1212w,/cdn-cgi/image/width=1296,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/health-safety/531x421-airport.jpg 1296w,/cdn-cgi/image/width=1578,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/health-safety/531x421-airport.jpg 1578w,/cdn-cgi/image/width=1818,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/health-safety/531x421-airport.jpg 1818w" alt="ISO 45001 certification" loading="lazy" decoding="auto" fetchpriority="auto" width="910" height="720" class="imageTextImg"> </div> <p class="promoBlockLabel imageTextLabel"> Caso de estudio </p> <p class="imageTextSummary"> El aeropuerto de Birmingham ha conseguido la certificación ISO 45001, que ayuda a gestionar los riesgos de 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1212w,/cdn-cgi/image/width=1296,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 1296w,/cdn-cgi/image/width=1578,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 1578w,/cdn-cgi/image/width=1818,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/iso_27001_0532x0421.jpg 1818w" alt="Servers" loading="lazy" decoding="auto" fetchpriority="auto" width="532" height="421" class="imageTextImg"> </div> <p class="promoBlockLabel imageTextLabel"> Caso de estudio </p> <p class="imageTextSummary"> LRQA ha certificado, bajo la norma internacional ISO/IEC 27001:2013, el Sistema de Gestión de la Información 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