Case Study

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

Let's Talk Risk! Podcast

Discusses You cannot reverse engineer your human factors regulatory strategy at the 11th hour.FDA’s new human …

Jun 19, 2026

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

Let's Talk Risk! Podcast

Discusses Imagine you are running a pivotal clinical trial for a novel implant. The data comes back, and it is…

Apr 10, 2026

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

Let's Talk Risk! Podcast

Discusses In this audio brief, we unpack a recent Class I recalls of the Boston Scientific Watchman TruSeal Ac…

Oct 20, 2025

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

Let's Talk Risk! Podcast

Discusses In this audio brief, We unpack an academic study that compares the EU’s MDCG 2019-16 and the FDA’s c…

Sep 22, 2025

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

Let's Talk Risk! Podcast

Discusses ai-regulation.

Sep 8, 2025

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

Let's Talk Risk! Podcast

Discusses machine-learning, ai-regulation.

Aug 25, 2025

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

Let's Talk Risk! Podcast

Discusses In this audio brief, we unpack a recent Class I recall of Medtronic's Newport HT70 and HT70 Plus ven…

Aug 11, 2025