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

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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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Main requirements of ISO 13485:2018. Risk management according to DSTU EN ISO 14971:2015.

The program of the event is available only on Ukrainian or Russian

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Features of medical device conformity assessment in wartime with or without conformity assessment body involvement

The Ukrainian Scientific Institute of Certification invites you to take part in the 11th Ukrainian Forum of Medical Devices Market Operators®. In this difficult period for our country, more than ever, it is necessary to be aware of the latest key changes in the functioning of the medical device market. Therefore, the Ukrainian Forum of […]

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