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ISO 14971 Fundamentals: Reasonably Foreseeable Misuse
Reasonably foreseeable misuse in the context of ISO 14971 is more than use-error.
 • 
Naveen Agarwal, Ph.D.
Case Study: When benefit-risk falls below expectations despite solid clinical data
To be judged as safe and effective by regulatory authorities, benefits of a medical device must outweigh risk, and must provide clinically significant…
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Naveen Agarwal, Ph.D.
Case study - when miscalculating risk leads to a warning letter
How a manufacturer of an ambulatory cardiac monitoring system got a warning letter from the FDA due to a simple calculation error.
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Naveen Agarwal, Ph.D.
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Book review - Hazard Analysis Primer
 • Naveen Agarwal, Ph.D.
Medical Device News Update - July 2023
Collaboration is the secret sauce for success in risk management
Quick Tip - A culture of quality naturally leads to excellence in risk management
Clinical evaluation is now more important than ever under EU-MDR
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35:04
LTR 30: It is time to unfake risk management!
Listen now | Insights from a Let's Talk Risk! conversation with Vilma Nasteckiene.
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Naveen Agarwal, Ph.D.
Medical Device News Update - October 2023
FDA approvals, warning letters and Class I recalls issued during October 2023.
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Naveen Agarwal, Ph.D.
Quick Tip: A hazard is more than just a potential source of harm
The term hazard causes a lot of confusion. Ericson's Hazard Analysis Primer can help practitioners develop a better understanding for risk analysis.
LTR Weekly Digest #13 - 18th November, 2023
Catch up on this week's articles: understanding reasonably foreseeable misuse, application of digital technologies and a risk-based approach to auditing…
31:40
LTR 29: Challenges and opportunities for digital technologies in medical applications
Listen now | Insights from a Let's Talk Risk! conversation with Pascal Werner.
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Naveen Agarwal, Ph.D.
Challenges and opportunities for digital technologies in medical applications
Insights from a Let's Talk Risk! conversation with Pascal Werner.
Quick Tip: Focus on quality system processes that most directly impact safety and effectiveness
Quality system audits are costly and time consuming. Make them count by using a risk-based approach to auditing by prioritizing high-risk processes and…
LTR Weekly Digest #12 - 11th November, 2023
Catch up on this week's articles: case study about benefit-risk, LTR conversation about building equity in design controls, and a quick reminder to use…
36:53
LTR 28: It is time to build equity in medical device design control
Listen now | Insights from a Let's Talk Risk! conversation with Lori-Ann Archer
 • 
Naveen Agarwal, Ph.D.
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Lori-Ann Archer
Let's Talk Risk!
Let's Talk Risk!
Elevating our collective capability in risk management across the global medical device industry to significantly improve patient safety, accelerate innovation and reduce cost.
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