{"id":3916,"date":"2026-05-26T09:14:47","date_gmt":"2026-05-26T06:14:47","guid":{"rendered":"http:\/\/sw-themes.com\/porto_dummy\/?post_type=event&p=3916"},"modified":"2026-06-22T12:15:13","modified_gmt":"2026-06-22T09:15:13","slug":"ivdr-2017-746-compliance-consultancy","status":"publish","type":"event","link":"https:\/\/demo.erayonetim.com\/en\/hizmetlerimiz\/ivdr-2017-746-uyum-danismanligi\/","title":{"rendered":"IVDR (2017\/746) Compliance Consulting"},"content":{"rendered":"
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\ud83d\udcc2 IVDR (2017\/746) Compliance Counseling<\/h4>\n

Are you ready for the new regulations for your in vitro diagnostic medical devices?<\/h4>\n

Avrupa Birli\u011fi\u2019nin yeni in vitro tan\u0131 t\u0131bbi cihaz y\u00f6netmeli\u011fi olan IVDR (EU) 2017\/746, \u00f6nceki IVDD (98\/79\/EC) direktifinin yerine ge\u00e7erek, cihazlar\u0131n g\u00fcvenli\u011fini, performans\u0131n\u0131 ve klinik kan\u0131tlar\u0131n\u0131 \u00e7ok daha g\u00fc\u00e7l\u00fc \u015fekilde d\u00fczenlemektedir. Artan denetim y\u00fck\u00fc ve s\u0131n\u0131f de\u011fi\u015fiklikleri nedeniyle, \u00fcreticilerin IVDR’a tam ve zaman\u0131nda uyum sa\u011flamas\u0131 kritik \u00f6nemdedir.<\/p>\n

Era Management provides end-to-end consulting services on technical, clinical, and regulatory issues throughout the IVDR compliance process.<\/p>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div><\/div>

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Services<\/h3>\n
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  • \u203a<\/span>Gap Analysis and Compliance Strategy: Analysis of existing documents in terms of compliance with IVDR and creation of a roadmap.<\/li>\n
  • \u203a<\/span>Technical File Preparation (Annex II and III): Preparation of technical documents in accordance with new requirements.<\/li>\n
  • \u203a<\/span>Device Classification and Conformity Pathway Determination: Determining the appropriate certification strategy based on your device's risk class.<\/li>\n
  • \u203a<\/span>Clinical Performance Studies and PER Preparation: Performance evaluation report (PER), creation of scientific validity, analytical and clinical performance data.<\/li>\n
  • \u203a<\/span>UDI and EUDAMED Consultancy: Managing product identification and EU system registration processes.<\/li>\n
  • \u203a<\/span>Quality Management System Integration: Establishment of an IVDR-compliant QMS structure integrated with ISO 13485.<\/li>\n
  • \u203a<\/span>PRRC (Person Responsible) Process: Structuring the personnel and responsibility structure under Article 15 of the IVDR.<\/li>\n
  • \u203a<\/span>Notified Body (NB) Process Support: Certification application, question-and-answer processes, and audit preparation.<\/li>\n<\/ul>\n<\/div>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div>
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    Correct Product Classification (IVDR Annex VIII)<\/h3>\n

    IVDR offers a much more detailed and stringent classification system than IVDD (Classes A, B, C, and D). These classes are determined by the clinical risk of the device and its impact on public health. Your device's class is crucial in terms of the certification pathway, clinical data requirements, and notified body obligations.<\/p>\n

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    • \u2714<\/span>Determining the correct class for your device.<\/li>\n
    • \u2714<\/span>Evaluation of class promotion situations<\/li>\n
    • \u2714<\/span>Borderline product review and guidance support.<\/li>\n
    • \u2714<\/span>Planning your compliance strategy according to the device class.<\/li>\n<\/ul>\n<\/div>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div><\/div>
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      The Importance of IVDR Compliance<\/h3>\n
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      • \u203a<\/span>Sustainability and product continuity in the European market.<\/li>\n
      • \u203a<\/span>Proving the safety and clinical validity of the device.<\/li>\n
      • \u203a<\/span>Speeding up success and approval processes in audits.<\/li>\n
      • \u203a<\/span>The advantage of integrating with new systems such as EUDAMED, UDI, and labeling.<\/li>\n<\/ul>\n<\/div>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div>
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        \u2705 Why Era Management?<\/h3>\n
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        \u25cf<\/span>IVDR’a \u00f6zel deneyimli dan\u0131\u015fman kadrosu<\/div>\n
        \u25cf<\/span>A holistic approach across clinical, technical, and regulatory fields.<\/div>\n
        \u25cf<\/span>Result-oriented support in the certification process.<\/div>\n
        \u25cf<\/span>Application support based on current MDCG guidelines.<\/div>\n<\/div>\n<\/div>\n\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 cihazlar\u0131n\u0131n yeni Avrupa Birli\u011fi reg\u00fclasyonuna uyum s\u00fcre\u00e7lerinde, performans de\u011ferlendirmelerinden s\u0131n\u0131fland\u0131rma kriterlerine kadar t\u00fcm gereklilikleri hassasiyetle yap\u0131land\u0131r\u0131yoruz.<\/p>","protected":false},"featured_media":4286,"menu_order":0,"template":"","class_list":["post-3916","event","type-event","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/event\/3916","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\/4286"}],"wp:attachment":[{"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/media?parent=3916"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}