Ukrainian Scientific Institute of Certification
22/07/2019
Significant scope expansion
UNI-CERT LLC received a new Accreditation certificate №1O302 from 13.05.2019 and significantly expanded its Scope of accreditation. In addition to medical products, it is now possible to conduct conformity assessment and certification of quality management systems (QMS) in the following areas: Personal protective equipment (PPE), Electromagnetic co...
18/07/2019
European Notified Bodies with whom agreements on recognition of conformity assessment results have been signed
Due to the increase of the quantity input of requests on the procedure of the recognition of European Notified Bodies conformity assessment results in relation to medical devices, we inform that at the moment UNI-CERT LLC has signed the agreements on recognition of conformity assessment results with: 1.  TÜV SUD Product Service GmbH (0123) 2....
17/07/2019
Impact of Law of Ukraine ‘On Ensuring the Functioning of the Ukrainian Language as the State Language’ on medical devices’ placing on the market and sales on the territory of Ukraine
On May 16, 2019, the Law of Ukraine “On Ensuring the Functioning of the Ukrainian Language as the State Language” was published. The Law enter into force on July 16, 2019, and transitional periods of 6 months have been set for a significant part of the provisions. The Law states that the only state (official) language in Ukraine is the Ukrainian...
04/07/2019
A contract on recognition of the results of the assessment of conformity with CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. (2409)
Dear colleagues! We are pleased to inform you that the notified body CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. (2409) has signed an arrangement for the recognition of conformity assessment results with the UNI-CERT LLC. Due to this collaboration, our clients can significantly reduce their time and financial expenses for certi...
19/06/2019
Conference ‘Market surveillance of medical devices in aesthetic medicine and dentistry’ was held on June 14, 2019
‘Premier Expo’ in conjunction with the Ukrainian Scientific Institute of Certification on June 14 at MIM Business School organized and conducted an educational event on topical issues of inspections by government market surveillance authorities of medical devices in aesthetic medicine and dentistry for managers of distributors and suppliers, regula...
03/06/2019
Expansion of the scope of accreditation
In February 2019, UNI-CERT LLC passed a scheduled audit and expanded its scope of accreditation. In accordance with new the accreditation certificate No. 80103 of 11.05.2019 and the scope of accreditation, UNI-CERT LLC is authorized to conduct activity on the certification of quality management systems (QMS) according to the following standards: ...
27/05/2019
A contract on recognition of the results of the assessment of conformity with ICIM S.p.A. (0425)
Dear colleagues! We are pleased to inform you that the notified body ICIM S.p.A. (0425) has signed an arrangement for the recognition of conformity assessment results with the UNI-CERT LLC. Due to this collaboration, our clients can significantly reduce their time and financial expenses for certification of their products in Ukraine. We have al...
26/04/2019
The workshop «New medical device and in vitro diagnostic medical device EU Directive» was held on April 12, 2019
At the end of 2018, UNI-CERT staff went through a course of new EU Directives in the Lloyd's Register Quality Assurance (LRQA) Notified Body (London, UK) and, together with the Association of market operators of medical devices (AMOMD), conducted a workshop on “New In Vitro Diagnostic Device and Medical Device EU Directive” on April 12, 2019. Th...
18/04/2019
Follow-up audit of NAAU for compliance with the requirements of DSTU EN ISO/IEC 17021-1:2015
In February 2019, the National Accreditation Agency of Ukraine (NAAU) conducted a follow-up audit to determine the level of compliance with the requirements of DSTU EN ISO/IEC 17021-1:2015 «Conformity assessment. Requirements for bodies providing audit and certification of management systems. Part 1: Requirements (ISO/IEC 17021-1:2015)». There have...
17/04/2019
Follow-up audit of NAAU for compliance with the requirements of DSTU EN ISO/IEC 17065:2014
In February 2019, the National Accreditation Agency of Ukraine (NAAU) conducted a follow-up audit to determine the level of compliance with the requirements of DSTU EN ISO/IEC 17065:2014 “Conformity assessment. Requirements for bodies certifying products, processes and services (EN ISO/IEC 17065:2012, IDT)” of the testing laboratory of the Limited ...