Publications

20.09.2021

Remote audits of global manufacturers of medical devices

Journal “Laboratory” No. 08/2020 The text of the article is available only in Ukrainian

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01.06.2021

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

Quality management // № 5 (41), May 2021 The text of the article is available only in Ukrainian

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01.05.2021

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

Quality management // № 4 (40), April 2021 The text of the article is available only in Ukrainian

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10.12.2020

Comparative characteristics of sterilization methods based on standards

PharmaTechExpo Journal №3-4, 2020 The text of the article is available only in Ukrainian

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24.09.2020

Stand-alone software as a medical device: Features of its classification and conformity assessment

Journal “Standardization, certification, quality” № 4 (122)/2020 Over the past decades, the frequency of using software in various areas of human life has increased significantly. In particular, this product has taken an important place in the medical industry. For example, as an integral part of a medical device (software incorporated in medical devices or pacemaker […]

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23.09.2020

Labeling of medical devices intended for showing, demonstrations at the place of fairs, exhibitions.

Especially for exhibitors InterCHARM-Ukraine, Pro Beauty Expo, Public Health, International Dental Forum. Full text of the article

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