Quality management of medical devices: we apply ISO 13485:2016 without errors

01.05.2021

Quality management // № 4 (40), April 2021

The text of the article is available only in Ukrainian

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18.02.2021

On the appointment of UNI-CERT as the conformity assessment body to perform as a third party certain tasks of conformity assessment

By the Orders of the Ministry of Economic Development, Trade and Agriculture of Ukraine, the Ukrainian Scientific Institute of Certification was appointed as a conformity assessment body to perform, as a third party, certain conformity assessment tasks defined in the relevant technical regulation, in accordance with the new requirements of the Law of Ukraine “On […]

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25.09.2023

The XVIII Specialized Conference BEAUTY TECH. INNOVATIONS IN PRODUCTION: RAW MATERIALS AND TECHNOLOGIES took place

The text of the news is available only in Ukrainian

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15.04.2021

Documents required for legal placement of medical devices on the market. Market surveillance.

PROGRAM Temporary changes in the rules of import of medical devices and personal protective equipment needed to prevent the COVID-19 Conformity assessment procedures: self-declaration or assessment with the involvement of a designated body Requirements for accompanying documentation: labeling, instructions for use, declaration of conformity Application of the requirements of the Law of Ukraine “On ensuring […]

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