🎧 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.

🎧 This episode of The Ginsbourg's Podcast, Season 2, Episode 4, host Shay Ginsbourg and Omer, the AI-Agent Co-Host, dive into the critical shift occurring in medical device validation. Based on their internal whitepaper "AI-Powered Medical Software Validation in 2026," they explore how the traditional, manual validation process has become an 18-month bottleneck to innovation, burdened by documentation, inefficient risk assessment, and test coverage gaps. The discussion details how Artificial Intelligence is fundamentally re-architecting the quality assurance lifecycle through 'Predictive Defect Analysis', 'Automated Traceability Matrix (RTM) generation', and 'AI-Assisted Test Case Generation', leading to a projected 30-50% reduction in time-to-market. The hosts also tackle the crucial regulatory challenge of "Validating the Validator," outlining the need for Explainability (XAI) and continuous monitoring under the intensifying pressure of the FDA's AI Guidance and the EU AI Act. Ultimately, they conclude that strategic AI implementation transforms validation from a static compliance cost into a dynamic, strategic competitive advantage, securing the "first-mover prize" for visionary Medical Device Manufacturers.

🎧 This episode of The Ginsbourg's Podcast, Season 2, Episode 3, delves into the transformative role of Artificial Intelligence in software testing. Join our host, Shay Ginsbourg, and AI co-host, Omer, as they navigate the complexities and benefits of integrating AI into QA processes. We'll explore various types of AI testing, its practical applications in test case generation, self-healing automation, defect prediction, and intelligent log analytics. The discussion will highlight how AI enhances efficiency, accuracy, and overall software quality, moving QA from reactive error chasing to proactive prevention. Discover how AI is not replacing human testers but empowering them to focus on strategic aspects, ultimately leading to faster cycles, fewer surprises, and lower costs in software development. Full article: https://www.mobileappdaily.com/knowledge-hub/ai-in-software-testing