Nikolay Matlaev

Lead specialist of conformity assessment division

  • Higher education, East-Ukrainian national University. V. Dalia, specialty “Metrology and measuring equipment”.
  • Master’s degree, East-Ukrainian national University. V. Dalia, master – “Standardization, certification and quality”.
  • More than 15 years of experience in the field of certification and conformity assessment-development, implementation, support and audit of quality management systems ISO 9001, ISO 13485
  • Experience in the field of conformity assessment of medical devices – more 6 years.
  • Lead auditor for ISO 9001: 2015 of the European Certification Authority for Management Systems AFNOR Group (France).
  • Auditor according to ISO 13485: 2016 of the European certification body for management systems AFNOR Group (France).
  • Conducted more 150 audits of quality management systems and conformity assessment of products of domestic and foreign enterprises.
  • Fluency in Ukrainian, Russian and English.

 Certificates of competence in the field of conformity assessment medical device

  • Certificate of competency of the auditor according to ISO 13485:2016;
  • Certificate of competency of the auditor on ISO 9001:2015;
  • Certificate the competence of the auditor to assess compliance with the requirements of the Technical regulations on medical devices approved by the PCM № 753 from 02.10.2013.),
  • Certificate the competence of the auditor to assess compliance with the requirements of the technical regulations applies to medical devices for in vitro diagnostics, approved by PCMU No. 754 from 02.10.2013.).

Other employees

Rostislav Hrynyk

Specialist of conformity assessment division

Oleksandra Yurkevych

Head of Conformity Assessment Division

Inna Osadcha

Specialist of of surveillance sector

Nataliia Zhalii

Lead specialist of conformity assessment division