On the appointment of UNI-CERT to conduct an assessment of compliance with the requirements of the Technical Regulations of personal protective equipment No. 761
In accordance with Order No. 1153 of 06/18/2020 of the Ministry of Economic Development, Trade and Agriculture of Ukraine, the Ukrainian Scientific Institute of Certification became the designated Body for Conformity Assessment to assess compliance with the Technical Regulations of Personal Protective Equipment, approved by the Cabinet of Ministers...
On March 22, 2020, Ukrainian Scientific Institute of Certification celebrated its 10th anniversary
This is a great opportunity to thank our staff for non-stop dedication and hard expert work we did together and continue to do, always keeping with our goals. Our successes and achievements had grown from collaboration and mutual support built by past and present generations of employees. We improve product quality, ensure compliance with requir...
A cycle of publications of our specialists in specialized media has begun
A new issue of a professional publication for pharmaceutical industry specialists PharmaTechExpo Journal (№1-2, 2020) has been released. Two articles of our experts have been published there. They open a series of publications in specialized media dedicated to technical regulation topics of a very wide range of medical devices. We hope that an info...
The Ministry of Economy of Ukraine provided an explanation regarding the unilateral recognition of EС-certificates
In early March 2020, the Association of Market Operators of Medical Devices (AMOMD™) sought professional advice on technical issues regarding legality and legality of assessing the conformity of medical devices to the requirements of relevant technical regulations by recognizing the results of conformity assessment carried out by notified bo...
The government has amended the technical regulations No. 753, 754 and 755
The Cabinet of Ministers of Ukraine published the Resolution of 05/06/2020, No. 347, which amended the Resolutions No. 753, No. 754 and No. 755, which approved the technical regulations for medical devices.
Follow-up audit of NAAU for compliance with the requirements of DSTU ISO/IEC 17025:2017
The National Accreditation Agency of Ukraine (NAAU) conducted annual follow-up audit to determine the level of compliance with the requirements of DSTU ISO/IEC 17025 “General requirements for the competence of testing and calibration laboratories” of the testing laboratory of the Limited liability company “Ukrainian Scientific Institute of Certific...
Be attentive! Cases of certificate falsification became more frequent!
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Uni-Cert, LLC introduced a mechanism for conducting remote audit (audit by telecommunication)
Due to the rapid growth of the COVID-19 pandemic, in view of the safety and well-being of the population, governments in the most countries of the world have introduced restrictive measures, including the introduction of a ban on passenger transportation, including air travel. Many countries have closed borders for foreign nationals. C...
European Commission postpones application of the Medical Devices Regulation (EU) 2017/745 to prioritize the fight against coronavirus
On April 3, 2020, the European Commission has adopted a proposal to postpone by one year the date of application of the Medical Devices Regulation (EU) 2017/745 to allow Member States, health institutions and economic operators to prioritize the fight against the coronavirus pandemic. This decision takes into account the unprecedented challenges of...
Expansion of the scope of accreditation
UNI-CERT LLC passed a scheduled audit and expanded its scope of accreditation. In accordance with new the accreditation certificate No. 80103 of 03.03.2020 and the scope of accreditation (Annex of July 26, 2020; Annex of March 03, 2020), UNI-CERT LLC is authorized to conduct activity on the certification of quality management systems (QMS) accordin...