Let's Talk Risk!
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My name is Naveen Agarwal. I am passionate about risk management of medical devices. My mission is to help elevate our collective capability in risk management across the global medical device industry so we can significantly improve patient safety, accelerate innovation and reduce cost.
Let’s Talk Risk! (LTR) helps me deliver on this long-term mission by:
serving as a credible source of information, insights and guidance for risk management of medical devices;
building a vibrant global community of risk practitioners for sharing best practices; and
facilitating access to highly affordable learning and coaching opportunities to practitioners worldwide for career advancement. Source
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| Language | English |
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Recent Articles
Search ArticlesQMSR QuickTake #43: QMS Risk Is Broader Than ISO 14971
In responding to Comment #32 in the preamble of the QMSR, FDA pointed manufacturers back to ISO 13485 Clause 0.2 within the standard. The term risk relates to device safety, device performance, and meeting applicable regulatory requirements. That clarification deserves attention because many medical device organizations still equate “risk management” almost entirely with ISO 14971. ISO 14971 is fundamental for managing safety risks associated with the medical device.
TAI #43: How Traceable Are Safety-Related Characteristics in Your Risk File?
A common starting point for identifying characteristics related to safety is the questionnaire in Annex A of ISO/TR 24971. It is a useful way to prompt teams to think broadly about materials, components, performance, use conditions, interfaces, and other characteristics that could affect safety. The problem is what often fails to happens next. The questionnaire gets completed, the characteristics are documented, and the activity is considered finished.
QMSR QuickTake #42: DHF Expectations Under the Design and Development File
In responding to Comment #31 in the preamble of the QMSR1, FDA also addressed the future of the Design History File (DHF). Under the former QS Regulation, the DHF provided the evidence that a device was developed in accordance with the approved design plan and design-control requirements. Under QMSR, FDA points manufacturers to ISO 13485 Clause 7.3.10, the Design and Development File.
TAI #42: How Much Confidence Is Enough?
Dear colleagues: In a recent TAI post, we looked at where uncertainty enters a risk estimate: the pathway to harm, probability, severity, risk control effectiveness, and the strength of the supporting evidence. Recognizing uncertainty is only the first step. The harder question is: When do we have enough confidence to make a risk decision? There is no universal threshold for the level of confidence needed to defend a risk decision.
Deep Dive: What FDA’s QMSR Warning Letters Are Revealing
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.
QMSR QuickTake #41: DHR Expectations Under the Batch Record Framework
In responding to Comment #31 in the preamble of the QMSR1, FDA addressed the future of familiar QS Regulation record terms, including Device History Record (DHR). Under the former QS Regulation, the DHR had a clear role. The Device Master Recrod (DMR) defined what should be made, and the DHR provided evidence that a specific device, batch, or lot was manufactured according to the DMR and Part 820. QMSR changes that vocabulary, but it does not remove the production-history expectation.
TAI #41: Uncertainty in Our Risk Estimates
Dear colleagues: We are accustomed to estimating risk, assigning a category in a risk matrix, and documenting whether residual risk is acceptable. Once that rating appears in the risk file, it can begin to look more certain than the evidence behind it really is. A risk estimate is our best current judgment about the probability of occurrence of harmand the severity of that harm.
Deep Dive: The PFAS Substitution Risk Paradox in Medical Devices
FDA: There is no reason to restrict the continued use of fluoropolymers in medical devices. What happens when pressure to eliminate a material creates greater risk for the patient? This Deep Dive examines the growing regulatory tension around PFAS and medical-device fluoropolymers, and why evaluating substitution requires more than asking whether a material belongs to a broad chemical category. Not all PFAS present the same risk.
QMSR QuickTake #40: MDF Is Not a Renamed DMR
In responding to Comment #31 in the preamble of the QMSR1, FDA addressed concerns about the relationship between the former Device Master Record (DMR) and the Medical Device File (MDF) requirement in ISO 13485. This is an important clarification because the Medical Device File is new terminology for many FDA-focused manufacturers. It may be tempting to treat the MDF as simply the new name for the old DMR. That would be too narrow.
TAI #40: Is Your Risk File Communicating Effectively?
Dear colleagues: In recent TAI posts, we have challenged how we define risk control effectiveness, how well we understand failure trajectories, and whether post-market surveillance can detect when those trajectories change. All of this points to a broader question: What is the risk file actually for? Too often, the risk file becomes primarily a compliance record—something maintained for design reviews, regulatory submissions, inspections, and audits.