History

2021
  • Designation by order of the Ministry of Economy of Ukraine in accordance with the requirements of the Law of Ukraine “On Technical Regulations and Conformity Assessment” to assess the conformity of medical devices to the requirements of the Technical Regulations on Medical Devices, approved by the Resolution of CMU No. 753.
  • Designation by order of the Ministry of Economy of Ukraine in accordance with the requirements of the Law of Ukraine “On Technical Regulations and Conformity Assessment” to assess the conformity of in vitro diagnostic medical devices to the requirements of the Technical Regulations on In vitro diagnostic Medical Devices, approved by the Resolution of CMU No. 754.
  • Designation by order of the Ministry of Economy of Ukraine in accordance with the requirements of the Law of Ukraine “On Technical Regulations and Conformity Assessment” to assess the conformity of personal protective equipment to the requirements of the Technical Regulations on Personal Protective Equipment, approved by the Resolution of CMU No. 771.
  • Extension of the UNI-CERT LLC Testing Laboratory accreditation scope by 23 standards and 127 test indicators in the scope of Personal Protective Equipment (PPE)
2020
  • The 1000th audit was conducted
  • Designation by order of Ministry of Economy as conformity assessment body for personal protective equipment
  • Introduction of a remote audit technique according to the requirements of IAF ID 3 and IAF MD 4
  • Extension of scope of accreditation to ISO/IEC 17021-1 for QMS certification according to ISO 22000
2019
  • Joined the European Business Association (EBA)
  • NAAU supervised audit in the presence of European co-operation for Accreditation (EA) observers
  • Extension of scope of accreditation for ISO/IEC 17065 for electrical equipment
  • Joined the American Chamber of Commerce (ACC) in Ukraine
2018
  • Training at Lloyd’s Register Quality Assurance (LRQA) (UK) on MDR and IVDR
  • The 500th conformity certificate
2017
  • NAAU granted accreditation for testing laboratory to ISO/IEC 17025
  • The 100th certificate was issued and the 100th audit was conducted
2016
  • First recognition agreement signed (TÜV SÜD)
  • Extension of scope of accreditation for ISO/IEC 17065 for personal protective equipment
  • Joined the Association of Medical Device Market Operators (AMOMD
2015
  • Designation by order of Ministry of Economy as conformity assessment body for medical devices and devices for in-vitro diagnostics. Identification number – UA.TR.116
  • NAAU accreditation according to ISO/IEC 17021-1 and ISO/IEC 17065
2010
  • Company established
  • Focus on assessment and development of regulatory documents for medicines and medical devices