{"id":7842,"date":"2021-09-06T13:42:58","date_gmt":"2021-09-06T10:42:58","guid":{"rendered":"https:\/\/uni-cert.ua\/?p=7842"},"modified":"2021-09-06T13:44:25","modified_gmt":"2021-09-06T10:44:25","slug":"sertifikacziya-virobnicztva-medichnih-virobiv-farmaczevtichnih-kompanij","status":"publish","type":"post","link":"https:\/\/uni-cert.ua\/en\/2021\/09\/06\/sertifikacziya-virobnicztva-medichnih-virobiv-farmaczevtichnih-kompanij\/","title":{"rendered":"Certification of medical device manufacturing by pharmaceutical companies"},"content":{"rendered":"<p style=\"text-align: center;\"><strong>PROGRAM<\/strong><\/p>\n<p>Nomenclature of medical devices in the &#8220;product portfolio&#8221; of pharmaceutical companies:<\/p>\n<ul>\n<li>medical devices supplied with a medicinal product<\/li>\n<li>medical devices for drug delivery<\/li>\n<li>products that are integral with the medicinal product<\/li>\n<li>products for IVD, RUO (research use only) and general laboratory equipment<\/li>\n<li>medical \/ cosmetic \/ hygienic purpose of products<\/li>\n<li>aids (accessories)<\/li>\n<\/ul>\n<p>Requirements of the international standard ISO 13485: 2018 Medical devices &#8211; Quality management systems &#8211; Requirements for regulatory purposes.<\/p>\n<p>Requirements of the national standard DSTU EN ISO 13485: 2018 Medical devices. Quality management system. Regulatory requirements<\/p>\n<p>The procedure for conducting audits of the QMS of companies producing medical devices.<\/p>\n<p><a href=\"https:\/\/uni-cert.ua\/en\/team\/nikolaj-matlaev\/\" target=\"_blank\" rel=\"noopener\">Nikolay Matlaev<\/a>, Lead Auditor of the Conformity Assessment Department of the Ukrainian Scientific Institute of Certification<\/p>\n","protected":false},"excerpt":{"rendered":"<p>PROGRAM Nomenclature of medical devices in the &#8220;product portfolio&#8221; of pharmaceutical companies: medical devices supplied with a medicinal product medical devices for drug delivery products that are integral with the medicinal product products for IVD, RUO (research use only) and general laboratory equipment medical \/ cosmetic \/ hygienic purpose of products aids (accessories) Requirements of [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":7843,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1,3,5],"tags":[],"class_list":["post-7842","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-sobytiya","category-study"],"acf":[],"_links":{"self":[{"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/posts\/7842","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=7842"}],"version-history":[{"count":3,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/posts\/7842\/revisions"}],"predecessor-version":[{"id":7846,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/posts\/7842\/revisions\/7846"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/media\/7843"}],"wp:attachment":[{"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/media?parent=7842"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/categories?post=7842"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/uni-cert.ua\/en\/wp-json\/wp\/v2\/tags?post=7842"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}