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 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

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