Los Angeles, CA – Bridging Consulting is excited to announce the release of Episode 6 of the podcast series, "Alexis and Ethan Explain It All." This episode offers a deep dive into the FDA’s Final Guidance on Predetermined Change Control Plans (PCCPs) for AI-Enabled Device Software Functions (AI-DSFs), a transformative regulation shaping the future of AI in healthcare.
What’s covered in Episode 6?
✅ Key updates and changes since the draft guidance released in April 2023.
✅ Impacts on manufacturers’ regulatory pathways and compliance strategies.
✅ Real-world implications for AI in healthcare, focusing on safety, innovation, and patient care.
📖 Read the full guidance document here.
🎧 Listen to both parts of Episode 6 now:
“This guidance represents a pivotal moment in regulating AI-enabled medical devices,” said Yu Zhao, founder of Bridging Consulting. “Through this episode, we aim to provide actionable insights for manufacturers and regulators navigating these evolving requirements.”
Stay tuned for future episodes of "Alexis and Ethan Explain It All," where we continue to explore critical regulatory trends and their impact on healthcare innovation.
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