Uni-CERT LLC

  • Address:
    Kudryavsky descent str., 7, office 32, c. Kyiv, 04053, Ukraine
  • Telephone:
    +38(044) 227-41-46, 338-07-82
  • Web-site:
    http://uni-cert.ua   
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.