Ukrainian Scientific Institute of Certification

NIKOLAY MATLAEV

06/05/2019

 

The lead auditor on certification of quality management systems and conformity assessment with technical regulations

nikolay.matlaev@uni-cert.ua

 

  • Higher education, East-Ukrainian national University. V. Dahl, specialty “Metrology and measuring equipment”.
  • Master’s degree, East-Ukrainian national University. V. Dalia, master – “Standardization, certification and quality”.
  • More than 12 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 – 4 years.
  • Conducted more 90 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 №ASAPS.025 from 26.04.2018 to 26.04.2021,
  • Certificate of competency of the auditor on ISO 9001:2015 №ASME.074 from 26.04.2018 to 26.04.2021,
  • Certificate №UA003.TR.107-18 from 31.08.2018 to 30.08.2021, 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 №UA003.TR.108-18 from 31.08.2018 to 30.08.2021, 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.).