Stand-alone software as a medical device: Features of its classification and conformity assessment

24.09.2020

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

Other news

25.06.2020

Features of the classification. Medical devices on the border of definitions.

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

Read more
10.12.2020

Comparative characteristics of sterilization methods based on standards

PharmaTechExpo Journal №3-4, 2020 The text of the article is available only in Ukrainian

Read more
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

Read more