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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 firmware), or as standalone software. One of the key questions that has medical software manufacturers before they put into service their devices is: the software really qualifies as a medical device or not. After all, not all software used in the medical field can be qualified as a medical device. In view of this, the purpose of this publication is to study the factors that can influence on the classification of stand-alone software and assessment of its conformity.
The text of the article is available only in Ukrainian
The Register of persons responsible for the placing medical devices on the market is displayed in public access on the official website of the State Service of Ukraine on Medicines and Drugs Control, providing the possibility of convenient search of information in the Register of Persons in accordance with the specified search parameters, at the […]
Read morePharmaTechExpo Journal | SPECIAL ISSUE 2021 The text of the article is available only in Ukrainian
Read morePROGRAM Devices at the border of definitions: medical devices supplied with the medicinal product; medical devices as a means of drug delivery; devices, an integral part of which is a medicinal product; devices for IVD, RUO (research use only) and general laboratory equipment. Conformity assessment through self-declaration. Conformity assessment performed by conformity assessment body: choosing […]
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