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Deep insights

LTR 123: Richard Matt on Effective Risk Communication
Richard Matt shares insights on how to effectively communicate patient safety risks to gain leadership buy-in.
25:48
Case Study: What AI/ML Device Recalls Reveal About Emerging Risks
Nearly half of AI/ML device recalls occur within the first year of FDA clearance, double the traditional 510k rate. Robust validation and active…
1
16:10
LTR 122: Tibor Zechmeister on PSUR Best Practices
Tibor Zechmeister talks about why PSUR should be a living snapshot of safety, and how best practices and AI can make compliance smarter, not harder.
32:47
LTR 121: Michelle Lott on Risk, CAPA and FDA Inspections under QMSR
Regulatory strategist Michelle Lott helps unpack how FDA’s shift to QMSR will reshape risk management, CAPA, and inspections, and what MedTech companies…
31:58
Medical Device Recalls Part 5: Understanding Broader Context
One recall can change the entire perception of safety. Part 5 of our deep dive series looks beyond raw counts to show how impact-based metrics uncover…
 • 
Naveen Agarwal, Ph.D.
Case Study: Contrasting U.S. and EU Approaches to AI Regulation
What the U.S. vs EU AI regulatory divide means for MedTech quality, regulatory, and risk leaders navigating a rapidly changing landscape.
12:57
LTR 120: Atty Chakraborty on India's Rising MedTech Sector
RAPS Rising Star Attrayee Chakraborty helps us unpack India’s fast-growing MedTech sector, and what it means for your career.
27:56
LTR 119: AI, Risk and Regulatory Strategy with Dr. Jay Vaishnav
A deep dive into navigating regulatory risk, PCCPs, and career advancement tips with Canon Medical’s Dr. Jay Vashnav.
1
31:05
Medical Device Recalls Part 4: Focus on Ventricular Assist Devices
Part 4 of our deep dive series reveals why two rival heart pumps, built for the same intended use, ended up with such different safety records and…
1
Case Study: When Clues to a Future Recall Hide in Plain Sight
Lessons learned from a recent Class I recall highlight the importance of active signal monitoring, cross-referencing with other similar issues, and…
 • 
Naveen Agarwal, Ph.D.
15:57
LTR 118: Off-Label Use with Kristen Petersen
Insights from a Let's Talk Risk! conversation with Kristen Petersen
25:53
Eight Practical Actions to Future-Proof Your AI-Enabled Medical Devices
MDVG 2025-6 guidance offers a roadmap to prepare your AI enabled medical devices for Notified Body review for compliance to both EU-MDR and EU AI Act.
 • 
Naveen Agarwal, Ph.D.
© 2025 Naveen Agarwal, Ph.D.
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