Publications Archives - Page 5 of 6

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

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

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 […]

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

25.06.2020

Features of the classification. Medical devices on the border of definitions.

PharmaTechExpo Journal №1-2, 2020. The text of the article is available only in Ukrainian

24.06.2020

Comparison of sterilization methods

Journal “Laboratory” No. 07/2020 The text of the article is available only in Ukrainian

Publications

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

Comparative characteristics of sterilization methods based on standards

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

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

Features of the classification. Medical devices on the border of definitions.

Comparison of sterilization methods

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