Let's Talk Risk! 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
Filtered episodes(2)
- StandardSummaries onlyDeep Dive: First FDA Warning Letter Under QMSR
Published Aug 7, 2026
Deep DiveUnder 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. The cited deficiencies extend across risk management, rework, corrective action, environmental controls, calibration, and software validation.The individual expectations are not entirely new. What has changed is the regulatory structure through which
- StandardSummaries onlyDeep Dive: FDA's RWE Guidance
Published Jul 24, 2026
Deep DiveReal-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 2017 guidance and provides a more detailed framework for determining when real-world data can generate evidence suitable for a medical device regulatory decision.One important change is FDA’s recognition that a sponsor’s inability to obtain participant-