Results for "Case Study"

Episodes

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  Case Study: FDA’s New Expectation for Use-Related Risk in Medical Device Submissions

  Let's Talk Risk! Podcast· Case Study· Jun 19, 2026

  You cannot reverse engineer your human factors regulatory strategy at the 11th hour.FDA’s new human factors guidance is not just about what goes into a marketing submission. It changes the way teams need to think about u…

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  Case Study: How Patient Preference Data Rescued a High-Risk Device

  Let's Talk Risk! Podcast· Case Study· Apr 10, 2026

  Imagine you are running a pivotal clinical trial for a novel implant. The data comes back, and it is rough: 80% of your patients have suffered a serious adverse event, and 40% have developed acute kidney injury.If you ar…

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  Case Study: The WATCHMAN TruSeal Recall and the Hidden Risk of Procedural Variation

  Let's Talk Risk! Podcast· Case Study· Oct 20, 2025

  In this audio brief, we unpack a recent Class I recalls of the Boston Scientific Watchman TruSeal Access System. What began as a rare but catastrophic risk of air embolism evolved into a global procedural-safety lesson f…

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  Case Study: Comparing EU and FDA Cybersecurity Guidance for Medical Devices

  Let's Talk Risk! Podcast· Case Study· Sep 22, 2025

  In this audio brief, We unpack an academic study that compares the EU’s MDCG 2019-16 and the FDA’s cybersecurity guidance, benchmarking them against international best practices. Both documents cover the basics, but each…

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  Case Study: What AI/ML Device Recalls Reveal About Emerging Risks

  Let's Talk Risk! Podcast· Case Study· Sep 8, 2025

  Note: this is an updated version of the original article first published on Sep 8. It has been corrected for an error in the number of AI/ML enabled medical devices cleared by the FDA mentioned in the original article.In…

  ai-regulation
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  Case Study: Contrasting U.S. and EU Approaches to AI Regulation

  Let's Talk Risk! Podcast· Case Study· Aug 25, 2025

  In this audio brief, we unpack the rapidly evolving AI regulatory landscape in the U.S. and EU. While the U.S. emphasizes rapid innovation with lighter-touch oversight, the EU is implementing a strict, risk-based framewo…

  machine-learningai-regulation
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  StandardSummaries only

  Case Study: When Clues to a Future Recall Hide in Plain Sight

  Let's Talk Risk! Podcast· Case Study· Aug 11, 2025

  In this audio brief, we unpack a recent Class I recall of Medtronic's Newport HT70 and HT70 Plus ventilators. These portable ventilators posed a grave risk—shutting down unexpectedly, potentially endangering patients on …