Summary
“If we don’t have connections and linkages in our risk management file from top to bottom, it’s hard to manage lifecycle risk.”
In this open discussion of the Let’s Talk Risk! conversation, host Naveen Agarwal explores a requirement in ISO 14971 that is often documented but not fully integrated into medical device risk management: characteristics related to safety.
Too often, organizations work through the questions in ISO/TR 24971 Annex A, document their answers, and file the document away. But identifying characteristics related to safety is only useful if those characteristics can be connected to hazards, hazardous situations, risk controls, design and manufacturing activities, supplier controls, and ultimately post-market data.
The discussion expands as participant Vid joins Naveen to explore usability and software examples, estimating probability of occurrence for repeatedly used devices, and the uncertainty involved in determining appropriate exposure denominators. Naveen also discusses supplier-related risk, why assumptions should be revisited as post-market evidence develops, and why risk management competence comes from combining practical experience with continued learning.
Listen to the full 25-minute podcast or jump to a section of interest listed below.
Chapters
00:00 – Introduction and the Open Discussion Format00:39 – What Are Characteristics Related to Safety?03:16 – Defining Safe Limits and Establishing Traceability06:19 – Connecting Post-Market Data to the Risk Management File07:47 – Usability, Software, and Safety-Critical User Actions11:01 – Post-Market Surveillance and Supplier-Related Risk13:38 – Building Risk Management Skills Early in Your Career16:03 – Estimating Probability of Occurrence for Repeated Device Use18:27 – Managing Uncertainty and Testing Your Assumptions19:21 – Are Medical Device Risks Being Underestimated?21:29 – Let’s Talk Risk as a Knowledge-Sharing Community24:50 – LTR Risk Coach and Closing Resources
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Suggested links:
LTR: ISO 14971 Fundamentals: Characteristics related to safety.
LTR: How Traceable Are Safety-Related Characteristics in Your Risk File?
LTR: LTR Risk Coach - AI-Powered Decision Support Tool.
Key Takeaways
* Annex A is guidance, not the end product. Answering the ISO/TR 24971 questions and filing the document away does not demonstrate how characteristics related to safety are actually being managed.
* Define safe limits where possible. Characteristics related to safety should have qualitative or quantitative limits where appropriate, and those limits should connect to the risk analysis and controls.
* Traceability should extend in both directions. Safety characteristics should connect upward to hazards, hazardous situations, and harms, and downward into design, manufacturing, supplier, and other operational controls.
* Post-market surveillance depends on that traceability. Without clearly identified characteristics and controls, complaints and other field signals become much harder to connect to changing product performance, manufacturing processes, or emerging risk.
* Supplier changes can create lifecycle risk. Safety-critical supplier characteristics need meaningful connections to the finished-device risk analysis; relying only on quality agreements and supplier audits may leave important gaps.
* Probability estimates require the right denominator. For repeatedly used devices, occurrence should be considered relative to meaningful opportunities for the event—not simply an easy or overly large denominator. Assumptions and uncertainty should be documented and periodically tested against post-market data.
* Risk management competence develops through practice. Naveen recommends combining hands-on involvement in real risk management work with targeted training and continued investment in professional development..
Keywords
ISO 14971, characteristics related to safety, risk traceability, hazard analysis, risk controls, post-market surveillance, probability of occurrence, supplier controls, lifecycle risk management, QMSR
About This Open Discussion
Let’s Talk Risk! open discussions are informal conversations focused on practical questions facing medical device professionals. Rather than a webinar or formal presentation, the format creates space for participants to raise questions, share experiences, and explore how risk management principles work in practice. As Naveen explains in the episode, the broader purpose of Let’s Talk Risk! is knowledge sharing and community building that helps professionals become more confident applying risk management principles.
Let’s Talk Risk! with Dr. Naveen Agarwal is a bi-weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every other Friday on LinkedIn.
Disclaimer
Information and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.
Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.
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