Artificial intelligence can be defined as “[a] machine’s ability to make decisions and perform tasks that simulate human intelligence and behaviour.”
Regarded as a transformative technology in the digital world, artificial intelligence or AI is bringing value to the field of medical devices today. Medical devices continue to incorporate artificial intelligence to perform or support medical applications, but regulatory requirements in the European Union (EU) and other major medical markets do not currently address the unique and complex characteristics of medical devices incorporating artificial intelligence (AI) and machine-learning (ML) technologies. This gap between advanced technologies that are available now and existing regulations poses a myriad of challenges to medical device manufacturers seeking device approval, while potentially putting patients at risk.
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