GOOD LUCK IN THE NEW YEAR!
Dear Colleagues! We congratulate you and wish you prosperity and the achievement of all your goals next year!
European Notified Bodies and laboratories 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....
A contract on recognition of the results of the assessment of conformity with MDC Medical Device Certification GmbH (0483)
Dear colleagues! We are pleased to inform you that the notified body MDC Medical Device Certification GmbH (0483) 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...
A useful opportunity for Ukrainian manufacturers of personal protective equipment!
The Office of the World Health Organization in Ukraine (WHO) is initiating a product evaluation to support Ukrainian manufacturers to confirm that WHO-recognized standards have been used to produce personal protective equipment (PPE) needed to prevent the COVID-19. Manufacturers who have received a certificate of conformity issued by a national ...
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
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...