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

Other news

01.02.2023

Register of persons responsible for the placing medical devices on the market has become operational in Ukraine

The Register of persons responsible for the placing medical devices on the market is displayed in public access on the official website of the State Service of Ukraine on Medicines and Drugs Control, providing the possibility of convenient search of information in the Register of Persons in accordance with the specified search parameters, at the […]

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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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08.06.2022

UNI-CERT received accreditation for DSTU EN ISO 22716:2015

The Ukrainian Scientific Institute of Certification became the FIRST conformity assessment body in Ukraine, accredited to carry out activities in a new line of business: DSTU EN ISO 22716:2015 Cosmetics. Good Manufacturing Practice (GMP). Guidelines on Good Manufacturing Practices (EN ISO 22716:2007, IDT) and EN ISO 22716:2007 Cosmetics – Good Manufacturing Practices (GMP) – Guidelines […]

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