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Quality management // № 4 (40), April 2021
The text of the article is available only in Ukrainian
After the events of 2014, Ukraine took the path of development, oriented towards the European Union. On September 1st, 2017, the Association Agreement between Ukraine and the EU entered into force. Ukraine assumed the responsibility to follow the path of harmonization with EU legislation and, as a result, some changes took place in the regulatory […]
Read moreWe are pleased to inform you that the notified body UDEM Uluslararası Belgelendirme Denetim Eğitim Merkezi San. ve Tic. A.Ş. (EU notified body 2292) 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 […]
Read moreOn January 6, 2023 the European Commission adopted a proposal to give more time to certify medical devices to mitigate the risk of shortages. The proposal introduces a longer transition period to adapt to new rules, as foreseen under the Medical Devices Regulation. The new deadlines depend on the medical devices’ risk class and will […]
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