Results for "Deep Dive"

Episodes

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  Deep Dive: When the Risk Baseline and the QMS Both Break Down

  Let's Talk Risk! Podcast· Deep Dive· Sep 25, 2026

  The baseline is completely broken and the iteration process is blind.FDA’s August 21, 2026 warning letter to Pensar Medical LLC illustrates a failure that goes well beyond incomplete documentation.The underlying risk-man…

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  Deep Dive: When FDA Qualifies the Ruler

  Let's Talk Risk! Podcast· Deep Dive· Sep 18, 2026

  A qualified tool does not eliminate regulatory scrutiny. It eliminates the need to keep proving that the same ruler works.What if one of the biggest sources of friction in medical device development is not the device its…

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  Deep Dive: What FDA’s QMSR Warning Letters Are Revealing

  Let's Talk Risk! Podcast· Deep Dive· Sep 11, 2026

  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 …

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  Deep Dive: The PFAS Substitution Risk Paradox in Medical Devices

  Let's Talk Risk! Podcast· Deep Dive· Sep 4, 2026

  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 regul…

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  Deep Dive: When Patient Preference Becomes Regulatory Evidence

  Let's Talk Risk! Podcast· Deep Dive· Aug 28, 2026

  Patient preference is no longer a soft qualitative afterthought.What if a device carries significant risks, but patients are willing to accept them for a meaningful clinical benefit?This Deep Dive examines how FDA’s evol…

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  Deep Dive: Designing Safety Into Autonomous Robotic Devices

  Let's Talk Risk! Podcast· Deep Dive· Aug 21, 2026

  The vulnerability of the modern clinical lab is quite literally concentrated at the point of the needle.Clinical laboratories have automated almost everything after the blood reaches the tube. Yet one of the most common …

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  Deep Dive: First FDA Warning Letter Under QMSR

  Let's Talk Risk! Podcast· Deep Dive· Aug 7, 2026

  Under QMSR, FDA is not only looking for individual quality failures. It is examining how failures connect across the entire quality system.FDA’s warning letter to Linemaster Switch Corporation provides an early look at Q…

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  Deep Dive: FDA's RWE Guidance

  Let's Talk Risk! Podcast· Deep Dive· Jul 24, 2026

  Real-world data does not become regulatory evidence simply because it is large, current, or readily available.FDA’s December 2025 final guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medic…