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The handbook is intended to guide organizations in the development, implementation and maintenance of their quality management system in accordance with ISO 13485. Organizations active in the medical device sector, such as manufacturers, importers, distributors, service providers, certification bodies or regulatory bodies, can benefit from this publication.</p></div> </div> <div class="other" itemprop="comment"> <p class="comment"><ul class="refine alternate"> <li><a class="btn btn-primary glyphicon-save" href="https://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100422_preview.pdf">Preview</a></li> <li><a class="glyphicon-link" href="https://www.iso.org/iso-13485-medical-devices.html">More information</a></li> </ul></p> </div> </div> </div> <div class="col-md-4 col-md-offset-1"> <div class="card store-box buy-box buybox" id="pub100422"> <div class="card-header text-center"><h4>ISO 13485:2016 - Medical devices - A practical guide</h4></div> <div class="card-body"> <span class="visually-hidden" id="indexReference_pub100422" data-index="ISO 13485:2016 - Medical devices - A practical guide"></span> <span class="visually-hidden" id="itemReference_pub100422">ISO 13485:2016 - Medical devices - A practical guide</span> <div class="visually-hidden" id="pubNumber_pub100422">pub100422</div> <form class="box-option" id="form_pub100422"> <div class="mb-3"> <div class="section-head mb-1 text-sm"> Idioma</div> <div class="form-group"> <select class="form-select form-select-sm bkilang" id="bkilang_pub100422"> <option value="en" >Inglés</option> </select> </div> </div> <div class="section-head mb-1 text-sm"> Formato</div> <div class="formats formats_pub100422" id="bkifmt_pub100422_en" style="display: none;"><div class="form-check text-sm" id="bkifmt_pub100422_en_1"> <input class="form-check-input" data-type="pub" data-price="98" checked="checked" type="radio" name="format_en" id="format_pub100422_en_1" value="01ub000000zdlyHAAQ~a05b0000005WV2ZAAW~a0fb000000R47L8AAJ"/> <label class="form-check-label" for="format_pub100422_en_1">PDF</label> </div><div class="form-check text-sm" id="bkifmt_pub100422_en_2"> <input class="form-check-input" data-type="pub" data-price="98" type="radio" name="format_en" id="format_pub100422_en_2" value="01ub000000zdlyHAAQ~a05b0000005WV2eAAG~a0fb000000WcVLyAAN"/> <label class="form-check-label" for="format_pub100422_en_2">Papel</label> </div></div></form> <div class="align-items-baseline box-price" itemprop="offers" itemscope itemtype="https://schema.org/Offer"> <div class="d-flex justify-content-center align-items-baseline gap-2"> <link itemprop="url" href="/sites/isoorg/contents/data/publication/10/04/PUB100422.html" /> <meta itemprop="availability" content="https://schema.org/InStock" /> <span class="currency"><abbr title="Francos suizos" itemprop="priceCurrency">CHF</abbr></span> <span class="price d-flex align-items-baseline gap-2"> <span class="amount" id="productPrice_pub100422" itemprop="price">98</span> </span> </div> </div> <div class="d-grid orderBasket box-action pb-0"> <button id="add_pub100422" class="btn btn-primary" data-bs-toggle="modal" data-bs-target="#iso-optout" onclick="javascript:addToBasket('pub100422', '1', 'en', 'pub')"> Añadir al carrito</button> </div> </div> <div id="priceConverter" class="smaller text-center p-3">Convertir Franco suizo (CHF) a <a id="convertLink_pub100422" target="_blank" href="https://www.xe.com/es/currencyconverter/convert/?Amount=98&From=CHF&To=EUR">tu moneda</a></div> </div> <div class="well"> <h4>Normas relacionadas</h4> <ul class="refine"><li><div class="hentry icon-standard" id="icon-standard_59752"> <div class="h5 entry-header"> <div class="entry-name"> <a href="/es/contents/data/standard/05/97/59752.html" >ISO 13485:2016</a></div> </div> <div class="entry-summary"><div class="">Medical devices — Quality management systems — Requirements for regulatory purposes</div></div> </div></li><li><div class="hentry icon-publication" id="icon-publication_100377"> <div class="h5 entry-header"> <div class="entry-name"> <a href="/es/contents/data/publication/10/03/PUB100377.html" >ISO 13485 - Quality management for medical devices</a></div> </div> <div class="entry-summary">A free brochure with tips for getting started with ISO 13485, requirements for quality management systems related to medical devices.</div> </div></li></ul></div> <br/> <ul class="refine"><li><h3>Comprar juntas</h3> <div class="card"> <div class="Paquete: 10 % de descuento"><span class="badge badge-card rounded-pill bg-dark"><i class="bi-box-regular me-2"></i>Paquete<span class="text-warning"> - 10 % de descuento</span></span> <h5 class="mt-2"><a href="/es/contents/data/publication/20/04/PUB200422.html" title="PUB200422">Productos sanitarios: los básicos</a></h5> <p>Este paquete agrupa las normas ISO esenciales para brindar un marco sólido para la gestión de la calidad y la gestión de riesgos en la industria de productos sanitarios.</p> <ul class="list-unstyled"> <li><i class="bi bi-file-regular me-2"></i>ISO 13485:2016</li> <li><i class="bi bi-book-regular me-2"></i>Guía práctica sobre ISO 13485:2016</li> <li><i class="bi bi-file-regular me-2"></i>ISO 14971:2019</li> <li><i class="bi bi-file-regular me-2"></i>ISO/TR 24971:2020</li> </ul> </div> <div class="card-footer d-flex justify-content-between align-items-center"><span class="format text-sm text-muted">Inglés | PDF</span> <div class="orderBasket"><span class="text-xs text-warning text-decoration-line-through"><span>CHF</span> <span class="fw-bold">658</span> </span> <span class="ms-2"> <span>CHF</span> <span class="fw-bold" id="productPrice_cs59752-pub100422-cs72704-cs74437">592</span> </span> </div> </div> </div></li></ul></div> </div> </div> </section> </div> <section id="related-info"> <div class="container"> <div class="row"> <div class="col-md-12"> <h3>Esto también le puede interesar</h3> </div> <div class="col-md-7"> <div class="media-list media-300"> <div class="media clearfix square media-news" id="media-news_Ref2465"> <div class="media-left"> <figure class=""> <a href="/es/contents/news/2019/12/Ref2465.html" title="Reducing the risks of medical devices: international guidance just updated" aria-label="Reducing the risks of medical devices: international guidance just updated"><img loading="lazy" src="/files/live/sites/isoorg/files/news/News_archive/2019/12/Ref2465/clinic-1807543.jpg/thumbnails/150x150" srcset="/files/live/sites/isoorg/files/news/News_archive/2019/12/Ref2465/clinic-1807543.jpg/thumbnails/150x150 150w, /files/live/sites/isoorg/files/news/News_archive/2019/12/Ref2465/clinic-1807543.jpg/thumbnails/300x300 300w" sizes="100px" class="img-fluid hover-zoom" alt="" /> </a></figure> </div> <div class="media-body"> <div class="entry-description small text-muted"> <span class="time text-muted"> <time class='updated' datetime='2019-12-18'>18 diciembre 2019</time> </span> </div> <div class="entry-header"> <div class="h5"> <a href="/es/contents/news/2019/12/Ref2465.html" title="" ><span class="entry-name">Reducing the risks of medical devices: international guidance just updated</span></a></div> <div class="entry-summary"> Virtually no medical procedure is without risk, but there are many ways to minimize it. One such way is through applying sound risk management processes to medical devices. The International Standard to …</div> </div> </div> </div><div class="media clearfix square media-news" id="media-news_Ref2318"> <div class="media-left"> <figure class=""> <a href="/es/contents/news/2018/08/Ref2318.html" title="FDA plans to use ISO 13485 for medical devices regulation" aria-label="FDA plans to use ISO 13485 for medical devices regulation"><img loading="lazy" src="/files/live/sites/isoorg/files/news/News_archive/2018/08/Ref2318/Ref2318.jpg/thumbnails/150x150" srcset="/files/live/sites/isoorg/files/news/News_archive/2018/08/Ref2318/Ref2318.jpg/thumbnails/150x150 150w, /files/live/sites/isoorg/files/news/News_archive/2018/08/Ref2318/Ref2318.jpg/thumbnails/300x300 300w" sizes="100px" class="img-fluid hover-zoom" alt="Dentists with a patient during a dental intervention." /> </a></figure> </div> <div class="media-body"> <div class="entry-description small text-muted"> <span class="time text-muted"> <time class='updated' datetime='2018-08-27'>27 agosto 2018</time> </span> </div> <div class="entry-header"> <div class="h5"> <a href="/es/contents/news/2018/08/Ref2318.html" title="" ><span class="entry-name">FDA plans to use ISO 13485 for medical devices regulation</span></a></div> <div class="entry-summary"> The US Food and Drug Administration (FDA), the government department that regulates the medical devices sector, announced its intention to use ISO 13485 as the basis for its quality system legislation.</div> </div> </div> </div><div class="media clearfix square media-news" id="media-news_Ref2220"> <div class="media-left"> <figure class=""> <a href="/es/contents/news/2017/09/Ref2220.html" title="New handbook helps medical devices sector improve its quality management system" aria-label="New handbook helps medical devices sector improve its quality management system"><img loading="lazy" src="/files/live/sites/isoorg/files/news/News_archive/2017/09/Ref2220/Ref2220.jpg/thumbnails/150x150" srcset="/files/live/sites/isoorg/files/news/News_archive/2017/09/Ref2220/Ref2220.jpg/thumbnails/150x150 150w, /files/live/sites/isoorg/files/news/News_archive/2017/09/Ref2220/Ref2220.jpg/thumbnails/300x300 300w" sizes="100px" class="img-fluid hover-zoom" alt="Electronic syringe with an automatic loading." /> </a></figure> </div> <div class="media-body"> <div class="entry-description small text-muted"> <span class="time text-muted"> <time class='updated' datetime='2017-09-25'>25 septiembre 2017</time> </span> </div> <div class="entry-header"> <div class="h5"> <a href="/es/contents/news/2017/09/Ref2220.html" title="" ><span class="entry-name">New handbook helps medical devices sector improve its quality management system</span></a></div> <div class="entry-summary"> The medical devices industry is one of the most highly regulated sectors in the world. Significant quality systems and product requirements must be satisfied to ensure the medical devices produced are …</div> </div> </div> </div></div> </div> <div class="col-md-4 col-md-offset-1"> <h4>Más información</h4> <ul class="refine"><li><div class="media clearfix square media-ilink" id="media-ilink_internal-link"> <div class="media-left"> <figure class=""> <a href="/es/home/standards/popular-standards/iso-13485--medical-devices.html" title="ISO 13485 — Medical devices" aria-label="ISO 13485 — Medical devices"><img loading="lazy" src="/files/live/sites/isoorg/files/standards/popular_standards/iso_13485_medical_devices/img/medical-devices.jpg/thumbnails/150x150" srcset="/files/live/sites/isoorg/files/standards/popular_standards/iso_13485_medical_devices/img/medical-devices.jpg/thumbnails/150x150 150w, /files/live/sites/isoorg/files/standards/popular_standards/iso_13485_medical_devices/img/medical-devices.jpg/thumbnails/300x300 300w" sizes="100px" class="img-fluid hover-zoom" alt="Magnetic Resonance Imaging machine AA a series of dramatically lightened MRI." /> </a></figure> </div> <div class="media-body"> <div class="entry-header"> <div class="h5"> <a href="/es/home/standards/popular-standards/iso-13485--medical-devices.html" title="" ><span class="entry-name">ISO 13485 — Medical devices</span></a></div> <div class="entry-summary"> Manage quality throughout the life cycle of a medical device with ISO 13485.</div> </div> </div> </div></li></ul></div> </div> </div> </section> <section class="bg-lightgray" id="contact"> <div class="container"> <div class="row"> <div class="col-md-4"> <h4>¿Tiene alguna duda?</h4> <p>Consulte nuestras <a href="/es/footer-links/help-support.html" title="help-support">Ayuda y asistencia</a></p></div> <div class="col-md-4"> </div> <div class="col-md-4"> </div> </div> </div> </section><div class="nav-breadcrumb print-footer bg-black"> <div class="container"> <div class="row"> <div class="col-sm-10 small">  <ol class="breadcrumb"> <li class="breadcrumb-item"><a href="/es/home" title="Página de inicio"><i class="bi-house" aria-hidden="true"></i></a></li> <li class="breadcrumb-item"> <a href="/es/tienda">Tienda</a> </li> <li class="breadcrumb-item"> <a href="/es/home/store/publication-list.html">Publications and products</a> </li> <li class="breadcrumb-item"></li></ol></div> <div class="col-sm-2 hidden-print text-end small mt-3 mt-sm-0"> <a role="button" class="dropdown-toggle text-white collapsed" data-bs-toggle="collapse" href="#collapseSitemap" target="_self" aria-expanded="false" aria-controls="collapseSitemap">Mapa del sitio</a> </div> </div> <div class="collapse border-top" id="collapseSitemap"> <div class="row">  <nav role="navigation" aria-label="Sitemap" class="sitemap-footer clearfix text-xs" id="nav-sitemap"><ul role='menubar' class='list-inline-6 clearfix nav-level1' ><li role='menuitem' class=' hasChildren firstInLevel' ><a class='nav-link ' title="Covering almost every product, process or service imaginable, ISO makes standards used everywhere." href='/es/normas'>Normas</a><ul role='menubar' class='list-unstyled nav-level2' ><li role='menuitem' class=' noChildren firstInLevel' ><a class='nav-link ' title="Whether you run a business, work for a company or government, or you are a consumer looking for goods and services that meet customer expectations: Find out what standards can do for you." href='/es/normas/beneficios'>Beneficios</a></li><li role='menuitem' class=' noChildren' ><a class='nav-link ' title="Here you can discover some of the best-known and most widely-used standards, as well as those that address recently emerged challenges affecting us all. 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