
À propos de ce podcast
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
181 épisodes · education
Let's Talk Risk! Podcast
Dernier épisodeDeep Dive: What FDA’s QMSR Warning Letters Are Revealing
À propos de ce podcast
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
Épisodes récents
- Deep Dive: The PFAS Substitution Risk Paradox in Medical Devices4 sept. · 20 min
- Deep Dive: When Patient Preference Becomes Regulatory Evidence28 août · 32 min
- Deep Dive: Designing Safety Into Autonomous Robotic Devices21 août · 21 min
- LTR 163: FDA’s New Risk Lens Under QMSR14 août · 28 min
- Deep Dive: First FDA Warning Letter Under QMSR7 août · 21 min
- LTR 162: Using HHE for Risk-Based Decisions31 juil. · 28 min
- Deep Dive: FDA's RWE Guidance24 juil. · 21 min
- LTR 161: AI Governance by Design17 juil. · 25 min
- Case Study: Why FDA Cybersecurity Expectations Are Really QMS Expectations10 juil. · 17 min
- LTR 160: IMSC26 Highlights - From Compliance to Proactive MedTech Safety3 juil. · 47 min