{"id":3915,"date":"2026-05-25T11:14:35","date_gmt":"2026-05-25T08:14:35","guid":{"rendered":"http:\/\/sw-themes.com\/porto_dummy\/?post_type=event&p=3915"},"modified":"2026-06-22T12:22:04","modified_gmt":"2026-06-22T09:22:04","slug":"fda-medical-device-consultancy","status":"publish","type":"event","link":"https:\/\/demo.erayonetim.com\/en\/hizmetlerimiz\/fda-tibbi-cihaz-danismanligi\/","title":{"rendered":"FDA Medical Device Advisory (USA)"},"content":{"rendered":"
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\ud83d\udcc2 FDA Medical Device Advisory (USA)<\/h4>\n

The US market presents both significant opportunities and rigorous regulations for medical device manufacturers. The FDA (US Food and Drug Administration) implements strict inspection and registration processes to ensure product safety and performance.<\/p>\n

At Era Management, with our expert team familiar with FDA processes, we ensure the smooth and efficient introduction of your medical device to the US market.<\/p>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div><\/div>

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Our FDA Consulting Services<\/h3>\n
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  • \u203a<\/span>Device Classification (Class I, II, III) and determining the regulatory pathway.<\/li>\n
  • \u203a<\/span>510(k) Applications (Premarket Notification)<\/li>\n
  • \u203a<\/span>Preparation of De Novo and PMA Applications<\/li>\n
  • \u203a<\/span>Compliance Indicators and Labeling Review<\/li>\n
  • \u203a<\/span>Manufacturer Registration and Device Listing (FURLS)<\/li>\n
  • \u203a<\/span>Design Control and QSR (21 CFR Part 820) Compliance Consulting<\/li>\n
  • \u203a<\/span>FDA Inspection Preparation and Representation Services<\/li>\n
  • \u203a<\/span>US Local Representative Service (US Agent)<\/li>\n<\/ul>\n<\/div>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div>
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    Why should you be FDA compliant?<\/h3>\n
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    • \u2713<\/span>ABD’de pazara giri\u015fin ve da\u011f\u0131t\u0131m\u0131n \u00f6n ko\u015fulu<\/li>\n
    • \u2713<\/span>International credibility and market value<\/li>\n
    • \u2713<\/span>Documentation of clinical safety and performance.<\/li>\n
    • \u2713<\/span>Institutional preparation against FDA inspections<\/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>International experience in FDA and SFDA applications.<\/div>\n
      \u25cf<\/span>Device class-specific strategic consulting<\/div>\n
      \u25cf<\/span>Complete preparation of technical and regulatory documents.<\/div>\n
      \u25cf<\/span>Comprehensive support in audit and representation processes.<\/div>\n
      \u25cf<\/span>Industry knowledge encompassing both the manufacturer and distributor sides.<\/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":"

      Amerika Birle\u015fik Devletleri pazar\u0131na giri\u015fin anahtar\u0131 olan FDA kay\u0131tlar\u0131, 510(k) bildirimleri ve reg\u00fclasyonel s\u00fcre\u00e7ler i\u00e7in kurumsal yap\u0131n\u0131z\u0131 Amerikan standartlar\u0131na tam uyumlu hale getiriyoruz.<\/p>","protected":false},"featured_media":4289,"menu_order":0,"template":"","class_list":["post-3915","event","type-event","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/event\/3915","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\/4289"}],"wp:attachment":[{"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/media?parent=3915"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}