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.
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.
In accordance with the accreditation certificate No. 80103 of 02.09.2020 and the scope of accreditation, UNI-CERT LLC is authorized to conduct activity on the certification of quality management systems (QMS) according to the following standards:
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.