Articles with tag: «medical devices»
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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.
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2016 № 5 About the definition of the classes of Cybersecurity of Medical devices.
The paper discusses problems of Cybersecurity (CS) digital medical devices (MD). Lists the main threats associated with unauthorized external cybervandalism (CV) MD for patient safety. The classification of MD depending on the level of initial security from CV. The rules identify classes of CS medical devices.