Let's Talk Risk!

Let's Talk Risk!

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LTR 111: How to sustain a community of practice for risk management
Insights from a Let's Talk Risk! conversation with Ronak Dunung.
29:04
Medical Device News Update - May 2025
FDA device approvals, warning letters, adverse events and recalls issued during May 2025
 • 
Naveen Agarwal, Ph.D.
Case Study: A Warning Letter Exposes Issues in Risk Analysis
Lessons learned from a recent FDA warning letter highlighting systemic issues in risk analysis, design verification and post-market vigilance for a…
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Naveen Agarwal, Ph.D.
17:10
LTR 110: Focusing on reliability to build safe medical devices
Deep insights from a conversation with Mitra Soltani.
1
26:12
Industry snapshot: MedTech confronting tariff headwinds amidst tepid growth
Leading MedTech companies reported modest growth and more than $2 billion in cumulative anticipated tariff impact on earnings late 2025. Here is how…
 • 
Naveen Agarwal, Ph.D.
Case Study: A Promising Device Fails in the Market Due to Usability Issues
5 years after acquiring a promising medical device, a major MedTech discontinued marketing following a Class I recall. Here are a few lessons learned…
 • 
Naveen Agarwal, Ph.D.
3
11:22
LTR 109: Focus on risk, not just testing, for biocompatibility of medical devices
Insights from a Let's Talk Risk! conversation with Marina Daineko.
3
28:27
3 critical gaps to address in lifecycle management of AI in MedTech
AI/ML applications in MedTech are rising exponentially. However, key gaps remain in governance and lifecycle management of AI systems to support rapid…
 • 
Naveen Agarwal, Ph.D.
You spoke, we listened!
Thanks for your feedback in our Let's Talk Risk! subscriber survey. Here are a few actions we plan to roll out in the near future.
 • 
Naveen Agarwal, Ph.D.

May 2025

LTR 108: Databases and automation tools for clinical evaluation
Insights from a Let's Talk Risk! conversation with Veronika Valdova.
27:41
Medical Device News Update - April 2025
FDA device approvals, warning letters, adverse events and recalls issued during April2025
 • 
Naveen Agarwal, Ph.D.
Quick Tip: Tailor human factors to level of automation when using AI in medical devices
As AI-enabled applications grow into increasing levels of automation, they present new challenges for human factors. Align your approach to the level of…
© 2025 Naveen Agarwal, Ph.D.
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