AI in medical devices

Artificial Intelligence in Medical Devices

White paper

White paper

Verifying and validating AI-based medical devices

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.


Why download the whitepaper?

  • Learn about the opportunities and challenges device manufacturers face when bringing medical devices with integrated AI software and other technologies to the market
  • Have an overview on the essential criteria that should be considered by manufacturers

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