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)     Video presentation 2020

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 26.12.2024 and the scope of accreditation UA, UNI-CERT LLC is authorized to conduct activity on the certification of quality management systems (QMS) according to the following standards:

• ДСТУ EN ISO 9001:2018 Системи управління якістю. Вимоги (EN ISO 9001:2015, IDT; ISO 9001:2015, IDT); ДСТУ ISO 9001:2015 Системи управління якістю. Вимоги (ISO 9001:2015, IDT); ISO 9001:2015 Quality management systems – Requirements;
• ДСТУ ISO 22000:2019 Системи управління безпечністю харчових продуктів. Вимоги до будь-якої організації в харчовому ланцюгу (ІSО 22000:2018, IDТ); ISO 22000:2018 Food safety management systems – Requirements for any organization in the food chain;
• ДСТУ EN ISO 13485:2018 Медичні вироби. Системи управління якістю. Вимоги до регулювання (EN ISO 13485:2016, IDT; ISO 13485:2016, IDT); ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes;
• ДСТУ EN ISO 22716:2015 Косметика. Належна виробнича практика (GMP). Настанови з належної виробничої практики (EN ISO 22716:2007, IDT); EN ISO 22716:2007 Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices.

In accordance with the accreditation certificate No. 1O302 of 09.01.2023 and the scope of accreditation UA, UNI-CERT LLC carries out activity to assess the conformity of products in the following areas:

• medical devices;
• medical devices for in vitro diagnostics;
• individual protection means.

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.

We would be happy to answer your questions, please contact us.