{"id":3918,"date":"2026-05-26T11:00:56","date_gmt":"2026-05-26T08:00:56","guid":{"rendered":"http:\/\/sw-themes.com\/porto_dummy\/?post_type=event&p=3918"},"modified":"2026-06-04T10:54:11","modified_gmt":"2026-06-04T07:54:11","slug":"iso-13485-quality-management-system","status":"publish","type":"event","link":"https:\/\/demo.erayonetim.com\/en\/hizmetlerimiz\/iso-13485-kalite-yonetim-sistemi\/","title":{"rendered":"ISO 13485 Quality Management Systems"},"content":{"rendered":"
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\ud83d\udcc2 ISO 13485 Quality Management System<\/h4>\n

International Harmonization, Quality Assurance and Sustainability for Medical Device Manufacturers<\/h4>\n

For companies operating in the medical device sector, ISO 13485:2016 is an internationally recognized quality management system standard. This standard mandates the establishment and maintenance of quality assurance systems throughout the design, manufacture, distribution, and sale of medical devices.<\/p>\n

Era Y\u00f6netim olarak, ISO 13485’e uyumlu bir kalite y\u00f6netim sistemi (QMS) kurulmas\u0131 ve mevcut sistemin standarda entegrasyonu konusunda uzman dan\u0131\u015fmanl\u0131k hizmetleri sunuyoruz. Deneyimli ekibimizle, t\u0131bbi cihaz sekt\u00f6r\u00fcne \u00f6zel ihtiya\u00e7lar\u0131n\u0131z\u0131 g\u00f6z \u00f6n\u00fcnde bulundurarak size \u00f6zel \u00e7\u00f6z\u00fcmler geli\u015ftiriyoruz.<\/p>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div><\/div>

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Our Scope of Services<\/h3>\n
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  • \u203a<\/span>Mevcut sistemlerin ISO 13485:2016’ya uygunluk a\u00e7\u0131s\u0131ndan de\u011ferlendirilmesi (GAP analizi)<\/span><\/li>\n
  • \u203a<\/span>Quality management system design in accordance with ISO 13485 standard.<\/span><\/li>\n
  • \u203a<\/span>Establishing the documentation structure (procedures, instructions, forms, etc.)<\/span><\/li>\n
  • \u203a<\/span>Integration of risk management and traceability processes.<\/span><\/li>\n
  • \u203a<\/span>Planning and conducting internal audits.<\/span><\/li>\n
  • \u203a<\/span>Structuring management review processes<\/span><\/li>\n
  • \u203a<\/span>Trainings (ISO 13485 awareness, internal auditor, etc.)<\/span><\/li>\n
  • \u203a<\/span>Certification process preparation and audit support services.<\/span><\/li>\n<\/ul>\n<\/div>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div>
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    Why ISO 13485?<\/h3>\n
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    • \u2713<\/span>Compliance with regulatory requirements such as MDR (EU 2017\/745) and FDA.<\/span><\/li>\n
    • \u2713<\/span>Quality infrastructure is essential for accessing global markets.<\/span><\/li>\n
    • \u2713<\/span>Improving process efficiency and product safety.<\/span><\/li>\n
    • \u2713<\/span>Gaining customer trust and brand reputation<\/span><\/li>\n<\/ul>\n<\/div>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div><\/div>
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      \u2705 Why Era Management?<\/h3>\n
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      \u25cf<\/span>Specialization in the healthcare sector<\/span><\/div>\n
      \u25cf<\/span>Expert team<\/span><\/div>\n
      \u25cf<\/span>Experience in national and international projects<\/span><\/div>\n
      \u25cf<\/span>Strong collaborations with certification bodies.<\/span><\/div>\n
      \u25cf<\/span>Strong communication<\/span><\/div>\n
      \u25cf<\/span>Solution-oriented<\/span><\/div>\n
      \u25cf<\/span>Customized project team<\/span><\/div>\n
      \u25cf<\/span>Company memory<\/span><\/div>\n
      \u25cf<\/span>A simplified, sustainable, and implementable system setup approach.<\/span><\/div>\n<\/div>\n<\/div>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div>
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      \"\"<\/div>\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n<\/div>","protected":false},"excerpt":{"rendered":"

      T\u0131bbi cihaz \u00fcreticileri i\u00e7in uluslararas\u0131 pazarlara g\u00fcvenle a\u00e7\u0131lman\u0131n, yasal reg\u00fclasyonlara tam uyum sa\u011flaman\u0131n ve \u00fcr\u00fcn g\u00fcvenli\u011fini en \u00fcst seviyede garanti alt\u0131na alman\u0131n temel kurumsal zorunlulu\u011fudur.<\/p>","protected":false},"featured_media":4287,"menu_order":0,"template":"","class_list":["post-3918","event","type-event","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/event\/3918","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/event"}],"about":[{"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/types\/event"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/media\/4287"}],"wp:attachment":[{"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/media?parent=3918"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}