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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23.01.2020

Guidelines for medical devices

The Ministry of Health of Ukraine approved guidelines that are developed on the basis of relevant documents of the European Commission (MEDDEV) for an unambiguous interpretation of technical regulations regarding medical devices, medical devices for in vitro diagnostics and active implantable medical devices. The recommendations are not legally binding, but should be taken into account […]

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14.06.2024

OBL-OEM CONFORMITY ASSESSMENT OF MEDICAL DEVICES Analysis of technical documentation, audits, supervisions and recertification

Text 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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