Let's Talk Risk! Podcast
Where MedTech professionals gain clarity and confidence to navigate complex decisions.Let’s Talk Risk! brings together MedTech leaders and practitioners for thoughtful conversations on the challenges that shape risk, quality, innovation, and leadership. With 150+ episodes and more than 30K downloads, it helps professionals gain the clarity and confidence to lead through complex decisions. naveenagarwalphd.substack.com
| Publishes | Weekly | Episodes | 177 | Founded | 3 years ago |
|---|---|---|---|---|---|
| Number of Listeners | Categories | How ToBusinessEducation | |||
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Latest Episodes
Under QMSR, FDA is not only looking for individual quality failures. It is examining how failures connect across the entire quality system.
FDA’s warning letter to Linemaster Switch Corporation provides an early look at QMSR enforcement in practice.... more
Summary
“When done well, HHE evolves from a procedural requirement into a strategic tool that reflects how your organization makes risk-based decisions.”
In this episode of the Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Kerry Fl... more
Real-world data does not become regulatory evidence simply because it is large, current, or readily available.
FDA’s December 2025 final guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, supersedes the 2... more
Summary
“Let’s treat AI governance by design as the connective tissue of a product lifecycle ecosystem.”
AI governance is often introduced as another layer of oversight—more procedures, approvals, documentation, and checklists. Ankita Mishra offers... more
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Apple Podcasts | #11 |  South Korea/Education/How To |
Apple Podcasts | #54 |  Sweden/Education/How To |
Apple Podcasts | #76 |  Israel/Education/How To |
Apple Podcasts | #124 |  Norway/Education/How To |
Apple Podcasts | #148 |  Belgium/Education/How To |
Apple Podcasts | #217 |  Ireland/Education/How To |
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Frequently Asked Questions About Let's Talk Risk! Podcast
What is Let's Talk Risk! Podcast about and what kind of topics does it cover?
This show centers on risk, quality, and leadership in medical devices, with a strong focus on regulatory strategy, risk management, and the practicalities of bringing evidence-based MedTech products to market. Across episodes, listeners hear from engineers, regulatory professionals, and industry veterans who share actionable guidance on QMS implementation, FDA inspections, AI governance in regulated environments, and strategies to improve safety and efficiency throughout the product lifecycle. A standout trait is the guest mix—senior practitioners and consultants who connect real-world examples (from IDEs and QMSR to VIP programs and AI-enabled devices) to concrete decision-making, making it a practical resource for teams navigating complia... more
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How many listeners does Let's Talk Risk! Podcast get?
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How many subscribers and views does Let's Talk Risk! Podcast have?
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Which podcasts are similar to Let's Talk Risk! Podcast?
These podcasts share a similar audience with Let's Talk Risk! Podcast:
1. Medical Device made Easy Podcast
2. Global Medical Device Podcast powered by Greenlight Guru
3. FDA Watch
How many episodes of Let's Talk Risk! Podcast are there?
Let's Talk Risk! Podcast launched 3 years ago and published 177 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.
How do I contact Let's Talk Risk! Podcast?
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What guests have appeared on Let's Talk Risk! Podcast?
Recent guests on Let's Talk Risk! Podcast include:
1. Kerry Flecknoe
2. Ankita Mishra
3. Olaf Hedrich
4. Aaron Joseph
5. Priya Setty
6. Atty Chakraborty
7. Vilma Nasteckiene
8. Erick Sugalski
To view more recent guests and their details, simply upgrade your Rephonic account. You'll also get access to a typical guest profile to help you decide if the show is worth pitching.