
Over deze 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 afleveringen · Stap voor stap
Let's Talk Risk! Podcast
Nieuwste afleveringLTR 165: Managing Characteristics Related to Safety
Over deze 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
Recente afleveringen
- Executive Brief: What FDA is Looking For in Your Tox Data to Ensure Safety9 okt · 24 min
- LTR 164: Susan Neadle on Combination Device Risk Management2 okt · 27 min
- Deep Dive: When the Risk Baseline and the QMS Both Break Down25 sep · 22 min
- Deep Dive: When FDA Qualifies the Ruler18 sep · 20 min
- Deep Dive: What FDA’s QMSR Warning Letters Are Revealing11 sep · 21 min
- Deep Dive: The PFAS Substitution Risk Paradox in Medical Devices4 sep · 20 min
- Deep Dive: When Patient Preference Becomes Regulatory Evidence28 aug · 32 min
- Deep Dive: Designing Safety Into Autonomous Robotic Devices21 aug · 21 min
- LTR 163: FDA’s New Risk Lens Under QMSR14 aug · 28 min
- Deep Dive: First FDA Warning Letter Under QMSR7 aug · 21 min