5 Steps to Operationalizing FDA’s QMSR
Автор: Kymanox, partner for the life science industry
Загружено: 2026-01-20
Просмотров: 87
Описание:
FDA’s new Quality Management System Regulation (QMSR) represents the most significant update to U.S. medical device quality requirements in decades. While often described as a “harmonization” with ISO 13485, the real impact goes far deeper than terminology or structure.
In this episode of Life Science Solutions, host Chris Adkins is joined by David Dlugo, Senior Director of Quality at Kymanox, to break down what QMSR actually changes in day-to-day operations. Drawing on more than 30 years of experience across pharma, medtech, and advanced manufacturing, David explains why risk-based thinking is no longer confined to design controls—and how it now extends across CAPA, supplier controls, training, document changes, and post-market activities.
The conversation explores common misconceptions around ISO 13485 certification, what FDA will still expect during inspections, where companies are underestimating effort, and how to sequence QMSR readiness work realistically. Beyond compliance, David also highlights the long-term business upside of global alignment and the mistakes that could undermine it if teams wait too long to act.
#fda #QMSR #compliance #iso13485 #quality
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