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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
Medical Device News Update - July 2025
FDA device approvals, warning letters, adverse events and recalls issued during July 2025
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Naveen Agarwal, Ph.D.
Quick Tip: Manage post-market changes through re-entrant design controls
Medical devices go through frequent updates during the post-market phase. Develop a nimble product development process and apply reentrant design…
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…
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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.
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Naveen Agarwal, Ph.D.
Quick Tip: A Great Product is Not Enough. You Also Need a Good Story.
The case of a promising medical device that solved a tough clinical problem offers a valuable lesson. You need to tell a good story to your users to…
LTR 117: Queenita Fernandes on Smart Use of AI for Clinical Evaluation
We now have several AI-driven tools that can be used to review clinical literature. Use them in a smart, collaborative manner to achieve the desired…
29:52
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