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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 1440w,/cdn-cgi/image/width=1920,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg 1920w,/cdn-cgi/image/width=2048,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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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" > Ensure quality with medical device QMS certification and training </h1> <p class="heroSubtitle" > ISO 13485 Certification, Training & Resources </p> <ul class="heroList" > <li class="heroListItem"> <a href="/en-my/iso-13485/#request-quote" class="arrowLink arrowLinkBold">Request a quote</a> </li> <li class="heroListItem"> <a href="/en-my/iso-13485/training/" class="arrowLink arrowLinkBold">ISO 13485 training</a> </li> <li class="heroListItem"> <a href="/en-my/iso-13485/#transfer-to-lrqa" class="arrowLink arrowLinkBold">Transfer to LRQA</a> </li> </ul> </div> </div><div class="stickyCtaContainer twoItems" id="MY-BA+sticky+CTA+-+BA"> <a href="tel:603 2700 7009" class="stickyCtaButton" > <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-letter"></use> </svg> </span> <span class="text"> +603 2700 7009 </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"> Request a quote </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">Request a quote</h3> <div class="stickyCtaDialogIframeContainer"> <iframe class="stickyCtaDialogIframe" src="https://info.lrqa.com/l/12702/2021-10-05/c4dt9x?" 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="/en-my/iso-13485/" class="swipeNavLink cta ctaTertiary"> <span class="text"> ISO 13485 </span> </a> </li> <li class="swipeNavListItem"> <a href="/en-my/iso-13485/training/" class="swipeNavLink cta ctaTertiary"> <span class="text"> Training </span> </a> </li> <li class="swipeNavListItem"> <a href="/en-my/iso-13485/resources/" class="swipeNavLink cta ctaTertiary"> <span class="text"> Resources </span> </a> </li> </ul> </div> </div> </div><div class="textBlock col-12 canvas canvasWhite" id="Introduction"> <div class="wysiwyg" > <p style="text-align: justify;">Streamline regulatory compliance and time-to-market. ISO 13485 is the international quality management system (QMS) standard for medical devices. The standard has been designed to help organisations demonstrate that their products meet stringent industry regulations and support patient safety through a risk-based approach to the QMS, an enhanced focus on regulatory requirements, and increased controls over suppliers. It applies to both organisations that manufacture devices and those that support device manufacturers, enabling them to optimize their processes and streamline product development lifecycles.</p> </div></div><div class="textBlock col-12 spacingSmall canvas canvasNavy" id="Our+services"> <div class="wysiwyg" > <h3 style="text-align: center;"><strong>Our ISO 13485 services</strong></h3> <p style="text-align: justify;">LRQA provides training, certification, and assessment services in accordance with ISO 13485 requirements. Delivered on-site, remotely, or through a blend of the two, our flexible services can be tailored to meet your business’s unique needs.</p> </div></div><div class="textBlock col-3 canvas canvasNavy" id="Training"> <div class="wysiwyg" > <p class="desktop-center"><img style="display: block; margin-left: auto; margin-right: auto;" src="/globalassets/icons/png-icons/LRQA-Advisory-Icon-Video-Call.png" alt="computer screen icon" width="167" height="90" /></p> <h4 style="text-align: center;">Training</h4> <p class="desktop-center">Build an understanding of QMS fundamentals with our range of training courses that have been designed for varying levels of experience and learning styles.</p> </div></div><div class="textBlock col-3 canvas canvasNavy" id="Gap+analysis"> <div class="wysiwyg" > <h6 class="desktop-center" style="text-align: center;"><img style="display: block; margin-left: auto; margin-right: auto;" src="/globalassets/icons/png-icons/LRQA-Advisory-Icon-Advisory-Gap-Analysis.png" alt="Gap analysis" width="97" height="90" /></h6> <h4 style="text-align: center;">Gap analysis</h4> <p class="desktop-center">An optional service where an LRQA auditor will work with you to identify any non-conformities in your existing QMS prior to your ISO 13485 audit.</p> </div></div><div class="textBlock col-3 canvas canvasNavy" id="Certification"> <div class="wysiwyg" > <h6 class="desktop-center" style="text-align: left;"><img style="display: block; margin-left: auto; margin-right: auto;" src="/globalassets/icons/png-icons/LRQA-Advisory-Icon-Certificates-Badges.png?epslanguage=en-MY" alt="certification badge" width="70" height="90" /></h6> <h6 style="text-align: center;">Certification</h6> <p class="desktop-center" style="text-align: center;">Our certification process validates your QMS according to ISO 13485 and then assesses its effectiveness to demonstrate its capabilities, helping you to build trust with stakeholders.</p> </div></div><div class="textBlock col-3 canvas canvasNavy" id="Integrated+audit"> <div class="wysiwyg" > <h6 class="desktop-center" style="text-align: left;"><img style="display: block; margin-left: auto; margin-right: auto;" src="/contentassets/9dc2007c749c4712a1ac9a62399b5ffc/intgerated-services-icon.png?epslanguage=en-MY" alt="cog icon" width="105" height="90" /></h6> <h6 style="text-align: center;">Integrated audit</h6> <p class="desktop-center">Integrating your QMS enables you to benefit from a more efficient and cost-effective integrated audit and surveillance program covering several functional areas.</p> </div></div><div class="textBlock col-12 spacingSmall canvas canvasNavy" id="Why+work+with+us"> <div class="wysiwyg" > <h3 style="text-align: center;"><strong>Why work with us?</strong></h3> </div></div><div class="textBlock col-6 spacingSmall" id="Global+capability"> <div class="wysiwyg" > <h6 class="desktop-center"><img style="display: block; margin-left: auto; margin-right: auto;" src="/contentassets/92fb0d161d0146818b870f0371a488cf/local-and-global.png?epslanguage=en-MY" alt="local and global.png" /></h6> <h6 class="desktop-center" style="text-align: center;">Global capability</h6> <p class="desktop-center" style="text-align: justify;">LRQA has a global network of qualified auditors. This means we’re everywhere you are, putting us in a position to provide a local service with a globally consistent approach and dedication to excellence in assurance. Our people are true technical experts with in-depth knowledge of quality management.</p> </div></div><div class="textBlock col-6 spacingSmall" id="Flexible+delivery"> <div class="wysiwyg" > <h6 class="desktop-center"><img style="display: block; margin-left: auto; margin-right: auto;" src="/contentassets/a837c8ab9b004094b42b29654cedfcdb/flexible-delivery.png?epslanguage=en-MY" alt="flexible delivery.png" /></h6> <h6 class="desktop-center" style="text-align: center;">Flexible delivery</h6> <p class="desktop-center" style="text-align: justify;">Our ISO 13485 training and certification services can be tailored according to the needs of your business and can be delivered on-site or remotely, or via a blended approach. If you opt for the latter, you’ll receive the same high-quality service with the added benefits of flexibility and fast delivery.</p> </div></div><div class="textBlock col-6 spacingSmall" id="History+of+firsts"> <div class="wysiwyg" > <h6 class="desktop-center"><img style="display: block; margin-left: auto; margin-right: auto;" src="/contentassets/9917321febc84893a900a36c3a8f8201/history-of-firsts.png?epslanguage=en-MY" alt="history of firsts.png" /></h6> <h6 class="desktop-center" style="text-align: center;">History of firsts</h6> <p class="desktop-center" style="text-align: justify;">We were the first to receive UKAS accreditation to deliver certification services for a range of standards across the globe. We continue to be instrumental in developing a variety of specific standards and frameworks across different sectors.</p> </div></div><div class="textBlock col-6 spacingSmall" id="Total+assurance"> <div class="wysiwyg" > <h6 class="desktop-center"><img style="display: block; margin-left: auto; margin-right: auto;" src="/contentassets/efe361be422043aab20b1c693657997b/beyond-compliance.png?epslanguage=en-MY" alt="beyond compliance.png" />Total assurance </h6> <p class="desktop-center" style="text-align: justify;">Our service doesn’t stop at compliance. LRQA experts are true specialists who work to add value through an effective and robust audit of your system.</p> </div></div><div class="textBlock col-12 spacingSmall" id="Transfer+to+LRQA"> <div class="wysiwyg" > <h3 style="text-align: center;"><a id="transfer-to-lrqa"></a><strong>Are you already certified to ISO 13485 and would like to transfer?</strong></h3> <p style="text-align: justify;">If you hold a valid accredited certificate of approval with another provider and you are considering moving, transferring your ISO 13485 certification to LRQA is simple. We'll work with you to ensure your transfer is as smooth as possible.<a id="request-quote"></a></p> </div></div> </section> <section class="grid bottomContent" > <div class="textBlock col-12 spacingSmall" id="Transfer+to+LRQA-shared+global"> <div class="wysiwyg" > <p style="text-align: center;"><a href="/en-my/transfer-certification-to-lrqa/?epslanguage=en-MY" class="cta">Transfer to LRQA</a></p> </div></div><div class="iframeBlock col-12" id="MY+BA+General+enquiry"> <iframe class="iframeBlockFrame" src="https://info.lrqa.com/l/12702/2021-10-03/c3jbyq?website_url=%2Fen-my%2Fiso-13485%2F&website_sector=&website_business_stream=" height="1800" loading="lazy" id="179405" scrolling="no"></iframe></div><div class="carouselBlock canvas canvasWhite col-12" id="S03.02+Generic+case+study"> <h2 class="carouselBlockHeading" > <strong>CASE STUDIES</strong> </h2> <div class="carousel"> <div class="carouselContent"> <ul class="carouselContentList"> <li> <div class="imageTextWrap themeMint"> <div class="imageText"> <h3 class="imageTextTitle"> Helping NGO, Terre de Hommes, help children globally.... </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/case-studies/case-studies-terre-des-hommes-lr/" 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/case-studies/case-studies-terre-des-hommes-lr/ 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/case-studies/case-studies-terre-des-hommes-lr/ 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/case-studies/case-studies-terre-des-hommes-lr/ 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/case-studies/case-studies-terre-des-hommes-lr/ 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/case-studies/case-studies-terre-des-hommes-lr/ 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/case-studies/case-studies-terre-des-hommes-lr/ 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/case-studies/case-studies-terre-des-hommes-lr/ 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/case-studies/case-studies-terre-des-hommes-lr/ 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/case-studies/case-studies-terre-des-hommes-lr/ 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/case-studies/case-studies-terre-des-hommes-lr/ 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/case-studies/case-studies-terre-des-hommes-lr/ 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/case-studies/case-studies-terre-des-hommes-lr/ 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/case-studies/case-studies-terre-des-hommes-lr/ 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/case-studies/case-studies-terre-des-hommes-lr/ 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/case-studies/case-studies-terre-des-hommes-lr/ 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/case-studies/case-studies-terre-des-hommes-lr/ 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/case-studies/case-studies-terre-des-hommes-lr/ 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/case-studies/case-studies-terre-des-hommes-lr/ 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/case-studies/case-studies-terre-des-hommes-lr/ 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/case-studies/case-studies-terre-des-hommes-lr/ 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/case-studies/case-studies-terre-des-hommes-lr/ 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/case-studies/case-studies-terre-des-hommes-lr/ 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/case-studies/case-studies-terre-des-hommes-lr/ 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/case-studies/case-studies-terre-des-hommes-lr/ 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/case-studies/case-studies-terre-des-hommes-lr/ 1818w" alt="Child asleep on a shoulder" loading="lazy" decoding="auto" fetchpriority="auto" width="532" height="420" class="imageTextImg"> </div> <p class="promoBlockLabel imageTextLabel"> Case Study </p> <p class="imageTextSummary"> Helping Terre de Hommes help children globally. Certification to ISO 9001:2015 redesigns the NGO’s operating structure. Read more... </p> <a href="/en-my/case-studies/terre-hommes-iso-9001/" class="imageTextLink arrowLink arrowLinkBold"> </a> </div> </div> </li> <li> <div class="imageTextWrap themeMint"> <div class="imageText"> <h3 class="imageTextTitle"> Oceanz: Making life-saving, medical 3D printing a global... </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/iso-13485-case-studies-oceanz-lr/" 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/iso-13485-case-studies-oceanz-lr/ 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/iso-13485-case-studies-oceanz-lr/ 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/iso-13485-case-studies-oceanz-lr/ 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/iso-13485-case-studies-oceanz-lr/ 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/iso-13485-case-studies-oceanz-lr/ 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/iso-13485-case-studies-oceanz-lr/ 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/iso-13485-case-studies-oceanz-lr/ 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/iso-13485-case-studies-oceanz-lr/ 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/iso-13485-case-studies-oceanz-lr/ 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/iso-13485-case-studies-oceanz-lr/ 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/iso-13485-case-studies-oceanz-lr/ 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/iso-13485-case-studies-oceanz-lr/ 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/iso-13485-case-studies-oceanz-lr/ 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/iso-13485-case-studies-oceanz-lr/ 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/iso-13485-case-studies-oceanz-lr/ 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/iso-13485-case-studies-oceanz-lr/ 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/iso-13485-case-studies-oceanz-lr/ 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/iso-13485-case-studies-oceanz-lr/ 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/iso-13485-case-studies-oceanz-lr/ 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/iso-13485-case-studies-oceanz-lr/ 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/iso-13485-case-studies-oceanz-lr/ 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/iso-13485-case-studies-oceanz-lr/ 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/iso-13485-case-studies-oceanz-lr/ 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/iso-13485-case-studies-oceanz-lr/ 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/iso-13485-case-studies-oceanz-lr/ 1818w" alt="X-ray of a head with jawbone highlighted" loading="lazy" decoding="auto" fetchpriority="auto" width="532" height="420" class="imageTextImg"> </div> <p class="promoBlockLabel imageTextLabel"> Case Study </p> <p class="imageTextSummary"> ISO 13485 certification to help Oceanz champion innovation and quality in life-saving, medical 3D printing technology. Read more... </p> <a href="/en-my/case-studies/oceanz-iso-13485/" class="imageTextLink arrowLink arrowLinkBold"> </a> </div> </div> </li> </ul> </div> <button type="button" disabled class="carouselBtn prev"> <span class="icon carouselButtonIcon"> <svg focusable="false" class="carouselButtonIcon"> <title>Previous</title> <use href="/static/images/svg.svg#svg-arrowSharp"></use> </svg> </span> </button> <button type="button" disabled class="carouselBtn next"> <span class="icon carouselButtonIcon"> <svg focusable="false" class="carouselButtonIcon"> <title>Next</title> <use href="/static/images/svg.svg#svg-arrowSharp"></use> </svg> </span> </button> </div> <div class="carouselBlockLinkWrap"> <a class="carouselBlockLink arrowLink arrowLinkBold" href="/en-my/case-studies/">See more case studies</a> </div> </div><div class="carouselBlock canvas canvasNavy col-12 spacingLarge" id="S03.01+Generic+insights+carousel+(2)"> <h2 class="carouselBlockHeading" > <strong>INSIGHTS</strong> </h2> <div class="carousel"> <div class="carouselContent"> <ul class="carouselContentList"> <li> <div class="imageTextWrap themePink"> <div class="imageText"> <h3 class="imageTextTitle"> 180124 The clock is ticking; transitioning to ISO 14001:2015 </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/__brand-cafe-images/5409-532x421-looking-down-on-forest-154411/" 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/__brand-cafe-images/5409-532x421-looking-down-on-forest-154411/ 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/__brand-cafe-images/5409-532x421-looking-down-on-forest-154411/ 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