HeyJaredLet's Talk Risk! with Dr. Naveen Agarwal
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.
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- Indexed episodes, last 90 days
- 7
- Latest publication
- Sep 11, 2026
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- Earliest in this view
- Jul 10, 2026
Latest episodes
Deep Dive: What FDA’s QMSR Warning Letters Are Revealing (opens the original)
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If you’re trying to manage risk in isolated silos, your quality management system is already obsolete. What happens when a supplier changes a device label without triggering design controls? When operators quietly rework nonconforming product? Or when serious post-market signals never make it back into the risk file? This Deep Dive examines recent FDA inspection and warning-letter examples through one common lens: the integration of risk management across the quality system. The cases illustrate
LTR 163: FDA’s New Risk Lens Under QMSR (opens the original)
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Summary “I don't think it's as easy to outsource risk as it used to be. Risk is pervasive now.” In this episode of the Let’s Talk Risk! conversation , host Naveen Agarwal speaks with Allyson Mullen , Director at Hyman, Phelps & McNamara, P.C., about what FDA’s early enforcement activity under the Quality Management System Regulation (QMSR) may tell medical device manufacturers about the agency’s evolving expectations. Using the first warning letter discussed in the episode as a starting point, A
Deep Dive: First FDA Warning Letter Under QMSR (opens the original)
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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. 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 whic
LTR 162: Using HHE for Risk-Based Decisions (opens the original)
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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 Flecknoe, Senior Manager, Global Quality – HHE at Getinge, about the role of Health Hazard Evaluations in postmarket risk management. Kerry explains that although organizations may use terms such as HHE, HHA, or HRA, the terminology is less important th
Deep Dive: FDA's RWE Guidance (opens the original)
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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 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 participa
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