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Changes in software as a medical device based on artificial intelligence technologies
PURPOSE: to develop a procedure for registering changes, notifying users about changes made, unifying software as a medical device based on artificial intelligence technologies (SaMD-AI) changes, as well as requirements for testing and inspections—quality control before and after making changes. MET...
Autores principales: | Zinchenko, Victoria, Chetverikov, Sergey, Akhmad, Ekaterina, Arzamasov, Kirill, Vladzymyrskyy, Anton, Andreychenko, Anna, Morozov, Sergey |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9188918/ https://www.ncbi.nlm.nih.gov/pubmed/35691995 http://dx.doi.org/10.1007/s11548-022-02669-1 |
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