{"id":27,"date":"2021-03-23T01:28:30","date_gmt":"2021-03-22T22:28:30","guid":{"rendered":"http:\/\/uni-cert.ua\/?page_id=27"},"modified":"2026-05-04T11:16:37","modified_gmt":"2026-05-04T08:16:37","slug":"o-nas","status":"publish","type":"page","link":"https:\/\/uni-cert.ua\/en\/o-nas\/","title":{"rendered":"About us"},"content":{"rendered":"<p style=\"text-align: justify;\">The Ukrainian Scientific Institute of Certification was founded in 2010. The Institute specialized in examination of registration documents on medicinal products and medical devices, including the assessment of the conformity of technical files with the requirements of the European legislation.<\/p>\n<p style=\"text-align: justify;\"><a href=\"https:\/\/uni-cert.ua\/wp-content\/uploads\/2024\/12\/uni-cert-presentation-ua-nov-2024.pdf\" target=\"_blank\" rel=\"noopener\">Corporate brochure, July 2024 ua (PDF)<\/a>\u00a0 \u00a0 \u00a0<a href=\"https:\/\/www.youtube.com\/watch?v=QMawx7jhhBU\" target=\"_blank\" rel=\"noopener\">Video presentation 2020<\/a><\/p>\n<p style=\"text-align: justify;\">In 2015, when the technical regulations on medical devices became mandatory, the Institute management, having taken into account the qualification and knowledge of its employees, decided to extend its scope of activities and to obtain from the Ministry of Economic Development and Trade of Ukraine appointment to carry out the assessment of devices conformity with the requirements of the Ukrainian legislation.<\/p>\n<p style=\"text-align: justify;\">In accordance with\u00a0the\u00a0<a href=\"https:\/\/uni-cert.ua\/wp-content\/uploads\/2026\/05\/atestat-80103-24_04_2026-web.jpg\" target=\"_blank\" rel=\"noopener noreferrer\">accreditation certificate No. 80103 of 24.04.2026<\/a>\u00a0and the\u00a0<a href=\"https:\/\/uni-cert.ua\/wp-content\/uploads\/2026\/05\/sfera_24_04_2026_do_atestatu_80103_compressed.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">scope of accreditation UA<\/a>, UNI-CERT LLC is authorized to conduct activity on the certification of quality management systems (QMS) according to the following standards:<\/p>\n<ul style=\"text-align: justify;\">\n<li>\u0414\u0421\u0422\u0423 EN ISO 9001:2018 \u0421\u0438\u0441\u0442\u0435\u043c\u0438 \u0443\u043f\u0440\u0430\u0432\u043b\u0456\u043d\u043d\u044f \u044f\u043a\u0456\u0441\u0442\u044e. \u0412\u0438\u043c\u043e\u0433\u0438 (EN ISO 9001:2015, IDT; ISO 9001:2015, IDT); \u0414\u0421\u0422\u0423 ISO 9001:2015 \u0421\u0438\u0441\u0442\u0435\u043c\u0438 \u0443\u043f\u0440\u0430\u0432\u043b\u0456\u043d\u043d\u044f \u044f\u043a\u0456\u0441\u0442\u044e. \u0412\u0438\u043c\u043e\u0433\u0438 (ISO 9001:2015, IDT); ISO 9001:2015 Quality management systems \u2013 Requirements;<\/li>\n<li>\u0414\u0421\u0422\u0423 EN ISO 22000:2022 \u0421\u0438\u0441\u0442\u0435\u043c\u0438 \u0443\u043f\u0440\u0430\u0432\u043b\u0456\u043d\u043d\u044f \u0431\u0435\u0437\u043f\u0435\u0447\u043d\u0456\u0441\u0442\u044e \u0445\u0430\u0440\u0447\u043e\u0432\u0438\u0445 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0456\u0432. \u0412\u0438\u043c\u043e\u0433\u0438 \u0434\u043e \u0431\u0443\u0434\u044c-\u044f\u043a\u043e\u0457 \u043e\u0440\u0433\u0430\u043d\u0456\u0437\u0430\u0446\u0456\u0457 \u0432 \u0445\u0430\u0440\u0447\u043e\u0432\u043e\u043c\u0443 \u043b\u0430\u043d\u0446\u044e\u0437\u0456 (EN ISO 22000:2018, ID\u0422; \u0406S\u041e 22000:2018, ID\u0422);<\/li>\n<li>\u0414\u0421\u0422\u0423 ISO 22000:2019 \u0421\u0438\u0441\u0442\u0435\u043c\u0438 \u043a\u0435\u0440\u0443\u0432\u0430\u043d\u043d\u044f \u0431\u0435\u0437\u043f\u0435\u0447\u043d\u0456\u0441\u0442\u044e \u0445\u0430\u0440\u0447\u043e\u0432\u0438\u0445 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0456\u0432. \u0412\u0438\u043c\u043e\u0433\u0438 \u0434\u043e \u0431\u0443\u0434\u044c-\u044f\u043a\u043e\u0457 \u043e\u0440\u0433\u0430\u043d\u0456\u0437\u0430\u0446\u0456\u0457 \u0432 \u0445\u0430\u0440\u0447\u043e\u0432\u043e\u043c\u0443 \u043b\u0430\u043d\u0446\u044e\u0437\u0456 (\u0406S\u041e 22000:2018, ID\u0422); ISO 22000:2018 Food safety management systems \u2013 Requirements for any organization in the food chain;<\/li>\n<li>\u0414\u0421\u0422\u0423 EN ISO 13485:2018 \u041c\u0435\u0434\u0438\u0447\u043d\u0456 \u0432\u0438\u0440\u043e\u0431\u0438. \u0421\u0438\u0441\u0442\u0435\u043c\u0438 \u0443\u043f\u0440\u0430\u0432\u043b\u0456\u043d\u043d\u044f \u044f\u043a\u0456\u0441\u0442\u044e. \u0412\u0438\u043c\u043e\u0433\u0438 \u0434\u043e \u0440\u0435\u0433\u0443\u043b\u044e\u0432\u0430\u043d\u043d\u044f (EN ISO 13485:2016, IDT; ISO 13485:2016, IDT); EN ISO 13485:2016 Medical devices \u2013 Quality management systems \u2013 Requirements for regulatory purposes (ISO 13485:2016, IDT); ISO 13485:2016 Medical devices \u2013 Quality management systems \u2013 Requirements for regulatory purposes;<\/li>\n<li>\u0414\u0421\u0422\u0423 EN ISO 22716:2015 \u041a\u043e\u0441\u043c\u0435\u0442\u0438\u043a\u0430. \u041d\u0430\u043b\u0435\u0436\u043d\u0430 \u0432\u0438\u0440\u043e\u0431\u043d\u0438\u0447\u0430 \u043f\u0440\u0430\u043a\u0442\u0438\u043a\u0430 (GMP). \u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0438 \u0437 \u043d\u0430\u043b\u0435\u0436\u043d\u043e\u0457 \u0432\u0438\u0440\u043e\u0431\u043d\u0438\u0447\u043e\u0457 \u043f\u0440\u0430\u043a\u0442\u0438\u043a\u0438 (EN ISO 22716:2007, IDT); EN ISO 22716:2007 Cosmetics \u2013 Good Manufacturing Practices (GMP) \u2013 Guidelines on Good Manufacturing Practices.<\/li>\n<li>Technical regulations on medical devices for in vitro diagnostics, approved by the resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013 No. 754, Appendix 4.<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">In accordance with the\u00a0<a href=\"https:\/\/uni-cert.ua\/wp-content\/uploads\/2025\/09\/1o302-attestat-04.09.25-web.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">accreditation certificate No. 1O302 of 04.09.2025<\/a>\u00a0and the\u00a0<a href=\"https:\/\/uni-cert.ua\/wp-content\/uploads\/2025\/09\/1o302_sfera-04.09.2025_compressed.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">scope of accreditation UA<\/a>, UNI-CERT LLC carries out activity to assess the conformity of products in the following areas:<\/p>\n<ul style=\"text-align: justify;\">\n<li>medical devices<\/li>\n<li>medical devices for in vitro diagnostics<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">The accumulated experience, qualification and knowledge of our employees and an effective management system (MS) in place make us competent and ready to address the issues relating to conformity assessment, including the certification of products and quality management systems. In addition, our employees are well-versed in the Ukrainian and international legislation, including regulations in the original language.<\/p>\n<p style=\"text-align: justify;\">We would be happy to answer your questions, please\u00a0<a href=\"http:\/\/uni-cert.ua\/en\/o-nas\/kontakty\/\" target=\"_blank\" rel=\"noopener noreferrer\">contact us<\/a><a href=\"https:\/\/uni-cert.ua\/ua\/kontakty\/\" target=\"_blank\" rel=\"noopener noreferrer\">.<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Ukrainian Scientific Institute of Certification was founded in 2010. The Institute specialized in examination of registration documents on medicinal products and medical devices, including the assessment of the conformity of technical files with the requirements of the European legislation. Corporate brochure, July 2024 ua (PDF)\u00a0 \u00a0 \u00a0Video presentation 2020 In 2015, when the technical [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-27","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/pages\/27","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/comments?post=27"}],"version-history":[{"count":82,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/pages\/27\/revisions"}],"predecessor-version":[{"id":25603,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/pages\/27\/revisions\/25603"}],"wp:attachment":[{"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/media?parent=27"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}