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Career Central Student Capstone Poster Display: Digital Healthcare Platforms and Artificial Intelligence in Global Regulatory Compliance for Medical Devices
Global regulatory compliance for medical devices integrating digital healthcare platforms and artificial intelligence (AI) tools and systems’ important considerations include warranting the safety and efficacy of these technologies over severe testing, clear algorithm design, strong data privacy measures, followed by continuing observations to address probable risks, with regulatory bodies such as the FDA. It is important to actively develop frameworks that guide these new and evolving technologies such as AI healthcare systems that several medical devices and healthcare companies use to gain regulatory approval.
Learning Objectives:
Upon completion of this session, participants should be able to describe how AI transforms and impacts medical device approval
Upon completion of this session, participants should be able to identify few regulatory challenges related to AI in medical devices
Upon completion of this session, participants should be able to understand US, EU and Asian regulatory approach key points for medical devices
