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.
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 regulating medical devices, including regulations in the original language.
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 September 2015, Uni-CERT was accredited by the National Accreditation Agency of Ukraine in accordance with ISO/IEC 17021:2011 (certificate of accreditation No. 8O103 of 2 September 2015 and the scope of accreditation) to certify the quality management systems for conformity with:
DSTU ISO 9001:2009 Quality management systems – Requirements;
ISO 9001:2008 Quality management systems – Requirements;
DSTU EN ISO 13485:2015 Medical devices – Quality management systems – Requirements for regulatory purposes;
DSTU ISO 13485:2005 Medical devices – Quality management systems – Requirements for regulatory purposes;
ISO 13485:2003/Cor1:2009 Medical devices – Quality management systems – Requirements for regulatory purposes;
EN ISO 13485:2012 Medical devices – Quality management systems – Requirements for regulatory purposes;
and in accordance with ISO/IEC 17065:2012 (certificate of accreditation No. 1O302 of 4 September 2015 and the scope of accreditation) to certify products, specifically:
medical devices;
active implantable medical devices;
in vitro diagnostic medical devices.
In December 2015, Uni-CERT was designated as a notified body (Order No. 1764 of the Ministry of Economic Development and Trade of 24 December 2015; identification number: UA.TR.116) to carry out the assessment of conformity with the requirements of the following technical regulations:
Technical regulation on medical devices, as approved by Resolution No. 753 of the Cabinet of Ministers of Ukraine of 2 October 2013;
Technical regulation on in vitro diagnostic medical devices, as approved by Resolution No. 754 of the Cabinet of Ministers of Ukraine of 2 October 2013.
We would be happy to answer your questions, please contact us.
Send email
Ukraine
