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Case Study: Comparing EU and FDA Cybersecurity Guidance for Medical Devices
The mere existence of guidance, even imperfect guidance, isn’t enough. Manufacturers have to actually implement those security principles diligently.
16:22
LTR 124: Omar Al Kalaa on Wireless Coexistence and Risk in Connected Medical Devices
Former FDA wireless scientist Omar Al Kalaa explains why wireless coexistence is not a checkbox, and how MedTech innovators must think in terms of…
28:12
Quick Tip: Act now to be ready for QMSR in 2026
QMSR goes into effect in February 2026. Lead your organization with a high senses of urgency to be fully compliant to this new regulatory framework that…
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
Help Us Shape the Future of MedTech Safety
We are gearing up for the 2026 MedTech Safety Conference in Boston! Your input will help us design an exceptional experience. Share your feedback in our…
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Naveen Agarwal, Ph.D.
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
14:36
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
Unlocking Insights with ChatGPT: Recalls and Adverse Events Workshop
Discover how to turn complex medical device safety data into meaningful insights using AI through guided practice and real-world case studies.
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Naveen Agarwal, Ph.D.

August 2025

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…
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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
© 2025 Naveen Agarwal, Ph.D.
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