Final digest seminar on the most important regulatory changes in 2020
Dear Colleagues! In 2020, the global pandemic radically affected the medical device market in Ukraine. A number of regulatory acts from different government agencies have greatly simplified the placing on the market of many medical devices, that has led to a change in the “rules of the game” for almost all suppliers and authorized repr...
New presentation of UNI-CERT
Dear colleagues and partners! Due to the epidemiological situation, it is not always possible to hold a personal meeting and tell about our company. We bring to your attention our new corporate presentation. We will be glad to cooperate! Нова презентація УНІ-СЕРТ українською New presentation of UNI-CERT in English Новая през...
UNI-CERT LLC has signed an agreement with the European laboratory CENTEXBEL
Dear colleagues and partners! We are pleased to announce that UNI-CERT LLC has signed an agreement with the European laboratory CENTEXBEL, accredited by BELAC for compliance with the requirements of EN ISO / IEC 17025 for testing various products. Thanks to such cooperation, our clients can significantly reduce the time for certification of...
The seminar will be held at the exhibition “PHARMATechExpo 2020” on October 28
October 28, 14.30 - 17.30 | hall №2 Seminar «Medical products in the range of pharmaceutical manufacturers. Conformity assessment of medical devices for in-vitro diagnostics» Registration Organizer: UNI-CERT, LLC
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....
UNI-CERT received new accreditation certificates for the next 5 years
The 5-year accreditation period of the Ukrainian Scientific Institute of Certification has ended this year. Over the years, our team has grown by almost 80%, held more than 150 seminars and webinars, made several dozen publications in specialized media, and started cooperation with 27 leading European notified bodies. During this time, we have b...
Labelling of medical devices for exhibitions
Dear exhibitors of InterCHARM-Ukraine, Pro Beauty Expo, Public Health, International Dental Forum! Market surveillance authorities have strengthened monitoring of medical devices exhibited at the expositions. Therefore, those that were not planned to be sold at the time of the exhibition, but are presented at the exhibition, may cause some compl...
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...