Navigating the AI Regulatory Storm: FDA, EU, and the 2026 Medical Device Landscape
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Navigating the AI Regulatory Storm: FDA, EU, and the 2026 Medical Device Landscape
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🎧 This episode of The Ginsbourg's Podcast, Season 2, Episode 5, host Shay Ginsbourg and Omer, the AI-Agent Co-Host, discuss the AI Medical Device Landscape in 2026. The integration of AI into medical devices is revolutionizing healthcare, but it also introduces complex new risks like algorithmic bias and performance drift. In this episode of The Ghinzbourg's Podcast, Host Shay Ginsbourg and AI Co-Host Guest, The Analyst, dive deep into the critical regulatory shifts defining the 2026 landscape. Drawing from a comprehensive whitepaper, they dissect the dual compliance challenge facing manufacturers: the FDA's new Enhanced Documentation levels and Predetermined Change Control Plans (PCCPs), and the EU's overlapping Medical Device Regulation (MDR) and the "High-Risk" classification under the new AI Act. This graduate-level discussion provides essential insights into risk analysis methodologies, the evolution of the FDA's Level of Concern, and the practical compliance checklists required to safely and responsibly bring innovative AI health technologies to market. Tune in for a 25-minute masterclass on navigating the future of medical AI regulation.