
Every Friday, Dr. Naveen Agarwal leads a Let's Talk Risk! conversation with industry colleagues to discuss practical challenges and share best practices in risk management. In the highly regulated world of medical devices, most practitioners struggle with the "how" of risk management. Regulatory requirements are complex, confusing and ever changing. Establishing an effective risk management proces... more
| Publishes | Twice weekly | Episodes | 150 | Founded | 2 years ago |
|---|---|---|---|---|---|
| Number of Listeners | Categories | EducationTechnologyHow To | |||

Summary
“Risk management should not be a compliance checkbox. It must actively govern design decisions and feedback loops across the product lifecycle.”
In this Let’s Talk Risk! conversation, host Naveen Agarwal sits down with Pujitha Gourabathini,... more
Summary
“QMSR isn’t about regulatory obligation; it’s about managing business risk, protecting customers, and preserving market share.”
In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal is joined by Steve Silverman to explore a qu... more
Summary
“The industry is aware of QMSR, but they’re not moving. Many are still holding their breath, hoping something will change.”
In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal is joined by Michelle Lott for a deep and practi... more
Summary
“FDA isn’t asking whether you followed the procedure. They are asking whether your system can assure consistent outcomes in the real world.”
In this episode of the Let's Talk Risk Podcast, Priya Setty joins host Naveen Agarwal to unpack why... more
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Apple Podcasts | #148 |
Recent interactions between the hosts and their guests.
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The content centers around risk management within the highly regulated medical device industry, where conversations frequently address the intricate balance between compliance, innovation, and practical application. Topics discussed encompass a range of challenges, from adapting to new regulatory frameworks like the Quality Management System Regulation (QMSR) to exploring the role of artificial intelligence in ensuring patient safety and enhancing medical device efficacy. The narrative emphasizes collaboration among industry professionals to share best practices and insights, covering themes such as benefit-risk evaluation, human factors in device design, and proactive compliance strategies as core areas of focus. A noteworthy aspect of thi... more
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These podcasts share a similar audience with Let's Talk Risk!:
1. Medical Device made Easy Podcast
2. Global Medical Device Podcast powered by Greenlight Guru
Let's Talk Risk! launched 2 years ago and published 150 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.
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Recent guests on Let's Talk Risk! include:
1. Michelle Lott
2. Priya Setty
3. Adam Isaacs Rae
4. Allison Komiyama
5. James Pink
6. Megan Kane
7. Bijan Elahi
8. Rick Wedge
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