EU certificate for medical devices: the thorny path of recognition

03.01.2024

Other news

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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16.09.2024

Quality management system at enterprises importing and selling medical devices. General information.

The program of the event is available only on Ukrainian

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28.10.2021

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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