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Regulatory, Quality Management Kunal K. Sengupta Regulatory, Quality Management Kunal K. Sengupta

Navigating AI Regulations: Insights on FDA’s AI/ML Guidance and the EU AI Act

How do the FDA's AI/ML guidance and the EU AI Act differ in regulating AI in life sciences?

What challenges do life sciences companies face when complying with both FDA and EU AI regulations?

How does the FDA's risk-based classification impact the development of AI-driven medical devices?

In what ways does the EU AI Act emphasize ethics and human rights in AI applications?

What strategies can companies adopt to navigate the complex AI regulatory landscape in the life sciences sector?

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