Publications

13.12.2023

Natal chart of a medical device: how is the MD class determined?

ThePharmaMedia The first independent pharmaceutical business portal. The text of the article is available only in Ukrainian

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27.11.2023

Contract manufacturing: requirements are becoming more stringent

ThePharmaMedia The first independent pharmaceutical business portal. The text of the article is available only in Ukrainian

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02.11.2023

Medical devices and medical devices for in vitro diagnostics: fundamental differences

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

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14.09.2023

Recognition of EU certificates for medical devices: prospects and opportunities

Quality 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 […]

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31.07.2023

How to implement a quality management system according to DSTU EN ISO 13485:2018 in the central sterilization department

Management of the healthcare institution No. 7 July 2023 The text of the article is available only in Ukrainian

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30.05.2022

The Pharmacy weekly has published a review article about the seminar “Relevance of medical device conformity assessment through EC-certificates recognition during martial law”

On 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 […]

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