Documenting the quality management system for the production of medical products according to ISO 13485:2018

01.06.2021

Quality management // № 5 (41), May 2021

The text of the article is available only in Ukrainian

Other news

28.02.2019

Legalization of import products for the Ukrainian market of medical products

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 […]

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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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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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