The main specialization of the company is the provision of services for assessing the compliance of medical devices with the requirements of the Technical Regulations for medical devices and the Technical Regulations of medical devices for in vitro diagnostics, as well as certification of quality management systems for compliance with the requirements of standards of the 9001, 13485, 22000 series and others.
Our experts have many years of experience in the field of certification of products and quality management systems. Leading specialists of the company have been engaged in the examination of registration / technical documentation and the examination of the results of preclinical and clinical studies of medical devices, medicines and other products for more than ten years.
Today, our customers are more than a hundred domestic and foreign companies. Among them are manufacturers of medical devices, healthcare facilities, food manufacturers and others.
Choosing the Ukrainian certification agency as a conformity assessment body, you get a reliable, responsible partner and enlist the support of a team of professionals in matters of product conformity assessment, certification of quality management systems and other issues.
In 2016, the National Accreditation Agency of Ukraine certified the competence of the UCA in accordance with the requirements of:
– ISO / IEC 17065 in the field of: medical devices, active medical devices that implant, in vitro diagnostic medical devices (Accreditation certificate of July 15, 2016 No. 10310);
– ISO / IEC 17021 in the field of: DSTU EN ISO 13485: 2018 «Medical devices. Quality Management System. Requirements to regulation»; EN ISO 13485: 2016 «Medical devices – Quality management systems – Requirements for regulatory purposes»; ISO 13485: 2016 «Medical devices – Quality management systems – Requirements for regulatory purposes» (Accreditation certificate of 31.01.2020 No. 80110).
APPOINTMENT OF THE UCA AS THE CONFORMITY ASSESSMENT BODY
By order of the Ministry of Economic Development, Trade and Agriculture of Ukraine dated 03.10.2019, No. 159, the UСA was appointed as the conformity assessment body to assess compliance with the requirements of the Technical Regulations for medical products for in vitro diagnostics, approved by the Cabinet of Ministers of Ukraine dated 02.10.2013 No. 754 .
Therefore, we can confidently guarantee that our laboratory ensures the reliability and accuracy of product test results in the declared field of accreditation.
WHAT WE CAN
Off. 1, 58/2, Sichovykh Striltsiv str., Kyiv, 04050, Ukraine
+38 (067) 764 48 40
+38 (098) 085 65 83
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