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LTR 143: Jennifer Mascioli-Tudor on Leading Proactive Quality in the QMSR Era
Summary
“Management review is no longer a check-the-box exercise. It’s the most powerful lever leaders have to drive proactive quality.”
In this episode of the Let’s Talk Risk Podcast, Naveen Agarwal sits down with Jennifer Mascioli-Tudor, an experienced Quality and Regulatory leader, to unpack what QMSR readiness really means in practice.
Jennifer shares what she’s seeing across the industry, from companies that are fully prepared to those that haven’t started, and explains why being ISO 13485 certified is not enough. The conversation dives deep into FDA inspection behavior, closed-loop risk…
The skinny
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