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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21.06.2020

Features of the production of sterile medical devices. Clean rooms.

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

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15.04.2022

Conformity assessment requirements for subcontracting manufacture (OBL-OEM). Technical file structure.

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

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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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