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LTR 138: Michelle Lott on QMSR Readiness, Risk-Based Assurance and FDA Expectations
Summary
“The industry is aware of QMSR, but they’re not moving. Many are still holding their breath, hoping something will change.”
In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal is joined by Michelle Lott for a deep and practical discussion on QMSR readiness as FDA’s February 2026 deadline rapidly approaches. Michelle shares a sobering view of where the medical device industry truly stands, highlighting a dangerous gap between awareness and action.
The conversation explores how FDA is signaling its expectations well before inspections begin, particularly through new…
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