University · Biomedical Engineering · Bioethics and Regulatory Affairs

AI and Digital Health Regulation

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FDA Digital Health Center of Excellence, SaMD risk classification, PCCP, EU MDR software provisions, cybersecurity, data governance, algorithmic bias, and post-market ML monitoring.

Inhaltsübersicht

  • Software as a Medical Device: Regulatory Classification and Scope
  • FDA Predetermined Change Control Plans and Adaptive AI Regulation
  • Cybersecurity Requirements for Connected Medical Devices
  • Data Governance, Algorithmic Bias, and Health Equity in AI Medical Devices
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