Changes in software as a medical device based on artificial intelligence technologies.
Victoria ZinchenkoSergey ChetverikovEkaterina AkhmadKirill ArzamasovAnton V VladzymyrskyyAnna AndreychenkoSergey MorozovPublished in: International journal of computer assisted radiology and surgery (2022)
This article discusses the need to control changes in the module of SaMD-AI, as innovative products influencing medical decision making. It justifies the need to control a module operation of SaMD-AI after making changes. To streamline and optimize the necessary and sufficient control procedures, a systematization of possible changes in SaMD-AI and testing methods was carried out.