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ThePharmaMedia The first independent pharmaceutical business portal. Medical devices and medical devices for in vitro diagnostics play a fundamental role in modern medicine. However, although both categories use the term “medical devices,” they have important differences in their purpose, use and regulation. The text of the article is available only in Ukrainian
ДетальнееQuality management // № 09 / 2023, September The procedure for assessing the conformity of medical devices through the recognition of EU certificates is one of the possible ways to introduce medical devices into circulation in conditions of war, pandemic or other force majeure circumstances that prevent conformity assessment bodies from conducting regular assessment procedures […]
ДетальнееManagement of the healthcare institution No. 7 July 2023 The text of the article is available only in Ukrainian
ДетальнееOn May 19, a webinar was held on the topic: “Relevance of medical device conformity assessment through EC-certificates recognition during martial law”, the speakers of which were Viktoriia Shevchenko, Head of the Conformity Assessment Department of UNI-CERT LLC and Yana Sydiakina, Leading Specialist of the Assessment Division of UNI-CERT LLC. The seminar showed the great […]
ДетальнееQuality management // № 1-2 (49-50), January 2022 Guaranteeing the safety of products for consumers is a very important component of the image of cosmetics manufacturers. The leading motivation for the transition to work on GMP will be the standardization of production processes and the implementation of measures that make it possible to produce high-quality, […]
ДетальнееOn December 16, the final Digest-seminar “The most important regulatory changes in the field of medical devices 2021” was held, the speaker of which was Victoria Shevchenko, head of the conformity assessment department of UNI-CERT LLC. During the seminar, the impact of the updated requirements for cosmetics on the field of medical devices, new European […]
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