Articles with tag: «classification of risks of application of software as a medical device»
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2019 № 3 About the classification of risks of application of the medical software in the Eurasian economic union
The rules of classification of risks of medical software – Software as a Medical Device (SaMD), adopted by the International forum of regulators of medical devices (IMDRF), the Eurasian economic Union (EAEU) and the European Union (EU). Formal models of these rules are described. A comparative analysis of the risk classes of SaMD is done, examples of which are described in the documents IMDRF, defined by these rules.