{"id":4184,"date":"2026-05-26T09:31:47","date_gmt":"2026-05-26T06:31:47","guid":{"rendered":"https:\/\/demo.erayonetim.com\/?post_type=event&p=4184"},"modified":"2026-06-04T13:01:12","modified_gmt":"2026-06-04T10:01:12","slug":"mdr-2017-745-compliance-consultancy","status":"publish","type":"event","link":"https:\/\/demo.erayonetim.com\/en\/hizmetlerimiz\/mdr-2017-745-uyum-danismanligi\/","title":{"rendered":"MDR (2017\/745) Compliance Consulting"},"content":{"rendered":"
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\ud83d\udcc2 MDR (2017\/745) Adaptation Counseling<\/h4>\n

Your Guarantee of Compliance with European Union Legislation for Medical Devices<\/h4>\n

The European Union's new regulation for medical devices, MDR (EU) 2017\/745, aims to maximize patient safety by introducing much more comprehensive and stringent requirements than the previous MDD directive. Full compliance with this regulation is mandatory for all medical device manufacturers in order to participate in the European market.<\/p>\n

At Era Management, we understand your obligations under the MDR and help you comply in a strategic and sustainable way.<\/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>MDR Compliance Assessment (Gap Analysis): We analyze your current system's compliance with MDR and identify areas for improvement.<\/li>\n
  • \u203a<\/span>Teknik Dosya Haz\u0131rl\u0131\u011f\u0131: MDR\u2019\u0131n Ek II ve Ek III’e uygun teknik dosya ve klinik de\u011ferlendirme belgelerinin haz\u0131rlanmas\u0131.<\/li>\n
  • \u203a<\/span>Product Classification: The MDR (2017\/745) classifies medical devices according to their risk levels and sets different certification, clinical data, and traceability requirements for each class. Correctly classifying your product ensures that the entire compliance process is based on sound principles. We help you determine the correct classification by considering your product's purpose, mode of use, duration of use, and invasiveness (Annex VIII).<\/li>\n
  • \u203a<\/span>Improving Risk Management Processes: Establishing a risk management structure integrated with ISO 14971.<\/li>\n
  • \u203a<\/span>Clinical Assessment and Follow-up: Establishing a clinical data strategy in accordance with MEDDEV and MDCG guidelines.<\/li>\n
  • \u203a<\/span>Consultancy on the Person in Charge (PRRC) Process: Meeting personnel requirements under Article 15 of the MDR.<\/li>\n
  • \u203a<\/span>Labeling and UDI Consulting: MDR-compliant product labeling, symbols, and EUDAMED registration processes.<\/li>\n
  • \u203a<\/span>Audit Preparation: System preparation and internal audits prior to Notified Body audits.<\/li>\n
  • \u203a<\/span>Product Classification and Borderline Consulting: Accurate product classification and development of regulatory strategies.<\/li>\n<\/ul>\n<\/div>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div>
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    Benefits of MDR Adaptation<\/h3>\n
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    • \u2713<\/span>Protecting access to the European market.<\/li>\n
    • \u2713<\/span>Increased patient and user safety.<\/li>\n
    • \u2713<\/span>Full compliance with regulator and accredited body expectations.<\/li>\n
    • \u2713<\/span>Strengthening brand reputation and reducing risks.<\/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>Industry experience in MDR and ISO 13485.<\/div>\n
      \u25cf<\/span>National and international experience<\/div>\n
      \u25cf<\/span>A holistic approach to clinical, technical, and regulatory issues.<\/div>\n
      \u25cf<\/span>A solution-oriented consulting model tailored to your company.<\/div>\n
      \u25cf<\/span>End-to-end support in certification processes.<\/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":"

      Avrupa Birli\u011fi t\u0131bbi cihaz reg\u00fclasyonunun getirdi\u011fi yeni ve kat\u0131 kurallara uyum s\u00fcrecinizi; teknik dosya haz\u0131rl\u0131\u011f\u0131ndan risk y\u00f6netimine kadar t\u00fcm a\u015famalarda u\u00e7tan uca, g\u00fcvenle y\u00f6netiyoruz.<\/p>","protected":false},"featured_media":4280,"menu_order":0,"template":"","class_list":["post-4184","event","type-event","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/event\/4184","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\/4280"}],"wp:attachment":[{"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/media?parent=4184"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}