Assessment of compliance of medical devices and equipment
\n\u2013 assessment process of medical equipment to the requirements of the technical regulation on medical devices according to the decree of the Cabinet of the Ministers of Ukraine dated 02.10.2013 \u2116753 (medical devices, medical equipment), or 02.10.2013 \u2116754 (medical devices in vitro), or 02.10.2013 \u2116755 (implantable medical devices).
\nCompliance certificate for medical devices and equipment may be executed on:
\n\u2014 commercially available product (certificate validity term in the case is 5 years);
\n\u2014 product batch (under an invoice).
\nThe assessment process of medical devices and machines (medical equipment) consists of several major stages (full cycle or, in other words, execution of a batch compliance certificate):
\n\u2014 development of quality system (creation of quality guideline);
\n\u2014 conduct of preclinical studies (see more details in section Preclinical studies);
\n\u2014 enterprise audit for compliance of a complex quality management system in product manufacture;
\n\u2014 clinical evaluation or clinical studies (see more details in section Preclinical studies);
\n\u2014 issue of a certificate of compliance with the technical regulation.
\nEvery enterprise should undergo all abovementioned stages in commercial assessment of medical devices and machines (or medical devices).
\nSpecialists of our company will help you to get a minimum set of documents which is necessary for the launch of working activity on assessment of compliance of medical devices and equipment (or a medical device) to the technical regulation.
\nExecution term of a batch compliance certificate of medical devices and equipment: 1-2 months.
\nExecution term of a lot compliance certificate of medical devices and equipment: 1-2 weeks
\nOther registration services:
\n\u2022 Registration of cosmetic products
\n\u2022 Drug registration
\n\u2022 Registration of disinfectants
\n\u2022 Registration of biologically active additives
\nWe work in all regions of Ukraine, call right now and get the European quality of service in available prices \u2014 \u200e0994700483<\/p>\n","protected":false},"excerpt":{"rendered":"
Assessment of compliance of medical devices and equipment \u2013 assessment process of medical equipment to the requirements of the technical regulation on medical devices according to the decree of the Cabinet of the Ministers of Ukraine dated 02.10.2013 \u2116753 (medical devices, medical equipment), or 02.10.2013 \u2116754 (medical devices in vitro), or 02.10.2013 \u2116755 (implantable medical \u0447\u0438\u0442\u0430\u0442\u044c \u0434\u0430\u043b\u044c\u0448\u0435…<\/a><\/p>\n","protected":false},"author":1,"featured_media":460,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4],"tags":[],"class_list":["post-266","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sertifikaciya"],"translation":{"provider":"WPGlobus","version":"3.0.0","language":"en","enabled_languages":["uk","ru","en"],"languages":{"uk":{"title":true,"content":true,"excerpt":false},"ru":{"title":true,"content":true,"excerpt":false},"en":{"title":true,"content":true,"excerpt":false}}},"acf":[],"_links":{"self":[{"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/posts\/266","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/comments?post=266"}],"version-history":[{"count":14,"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/posts\/266\/revisions"}],"predecessor-version":[{"id":546,"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/posts\/266\/revisions\/546"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/media\/460"}],"wp:attachment":[{"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/media?parent=266"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/categories?post=266"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/tags?post=266"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}