{"id":26165,"date":"2026-06-24T11:30:49","date_gmt":"2026-06-24T08:30:49","guid":{"rendered":"https:\/\/uni-cert.ua\/?p=26165"},"modified":"2026-06-24T11:39:39","modified_gmt":"2026-06-24T08:39:39","slug":"iso-13485-klyuchovi-osoblyvosti-standartu-dlya-vyrobnykiv-medychnyh-vyrobiv","status":"publish","type":"post","link":"https:\/\/uni-cert.ua\/en\/2026\/06\/24\/iso-13485-klyuchovi-osoblyvosti-standartu-dlya-vyrobnykiv-medychnyh-vyrobiv\/","title":{"rendered":"ISO 13485: Key features of the standard for medical device manufacturers"},"content":{"rendered":"<p style=\"text-align: justify;\"><a href=\"https:\/\/ya.techmedia.com.ua\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-size: 12pt;\">Quality management \/\/ \u2116 6, June 2026<\/span><\/a><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">In an era of intensive development of medical technologies, ensuring the quality and safety of medical products is becoming not just a competitive advantage, but a critical requirement for successful functioning in the global market.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\"><strong>The international standard ISO 13485<\/strong> is a comprehensive quality management system developed specifically for the medical device industry, which helps organizations not only meet regulatory requirements, but also demonstrate their commitment to the highest standards of safety and effectiveness.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">The implementation of this standard creates a solid foundation for the entire production process, from conceptual design to final disposal of products, ensuring the confidence of patients, healthcare professionals and regulatory authorities in the quality of products.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">The text of the article is available only in\u00a0<a href=\"https:\/\/uni-cert.ua\/2026\/06\/24\/iso-13485-klyuchovi-osoblyvosti-standartu-dlya-vyrobnykiv-medychnyh-vyrobiv\/\" target=\"_blank\" rel=\"noopener\">Ukrainian<\/a><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Quality management \/\/ \u2116 6, June 2026 In an era of intensive development of medical technologies, ensuring the quality and safety of medical products is becoming not just a competitive advantage, but a critical requirement for successful functioning in the global market. The international standard ISO 13485 is a comprehensive quality management system developed specifically [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":26166,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1,4],"tags":[],"class_list":["post-26165","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-publikaczii"],"acf":[],"_links":{"self":[{"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/posts\/26165","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/comments?post=26165"}],"version-history":[{"count":9,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/posts\/26165\/revisions"}],"predecessor-version":[{"id":26177,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/posts\/26165\/revisions\/26177"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/media\/26166"}],"wp:attachment":[{"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/media?parent=26165"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/categories?post=26165"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/tags?post=26165"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}