CHALLENGES OF CLASSIFICATION OF STAND-ALONE SOFTWARE AS A MEDICAL DEVICE
Keyword(s):
Through a broad literature review, analysis of EU, USA, Ukraine regulation acts, scientific research, and opinions of progressive-minded people in this sphere, this paper provides a guide to understanding the essence of classification of stand-alone software with medical purpose and specifics of its regulation. This research is based on dialectical, comparative, analytic, synthetic, and comprehensive methods.
2015 ◽
Vol 66
(1)
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pp. 14-27
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2021 ◽
pp. 193758672110079
2020 ◽
Vol 69
(1)
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pp. 392-395
2016 ◽
Vol 6
(21)
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pp. 11-17
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