Ukrainian Scientific Institute of Certification
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 ...
05/04/2019
Testing laboratory of “UNI-CERT” LLC has expanded its equipment fleet with a new tearing machine MRM–30
Testing laboratory of “UNI-CERT” LLC is constantly working on the development and expansion of the range of services provided. We look forward to further cooperation!
29/03/2019
UNI-CERT is a new member of the European Business Association (EBA)
We are pleased to announce that UNI-CERT LLC became new member of the European Business Association (EBA) in 2019. We are confident that this event will help us not only to increase the number of potential business partners, but, thanks to the constant participation of our specialists in the work of the Health Care Committee, will provide a good op...
26/03/2019
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....
25/03/2019
A contract on recognition of the results of the assessment of conformity with BSI Group The Netherlands B.V. (2797)
Dear colleagues! We are pleased to inform you that the notified body BSI Group The Netherlands B.V. (2797) 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 Ukr...