Currently browsing "FDA"
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FDA QMSR Explained: What Medical Device Companies Must Know Before 2026
The U.S. Food and Drug Administration finalized the Quality Management System Regulation (FDA QMSR) in February 2024, replacing the Quality System Regulation (QSR) that has governed medical device manufacturing since 1996. This FDA QMSR represents a fundamental shift toward harmonizing U.S. regulations with ISO 13485:2016, the internationally recognized medical device quality management system standard. Medical […]
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Training Best Practices: Building a Culture of Quality with Your Food Quality Management System
In the competitive food industry, compliance with safety and quality standards isn’t just about avoiding regulatory penalties but building consumer trust and brand reputation. However, many organizations struggle to move beyond a checkbox approach to food quality management. The missing ingredient? Practical training that transforms requirements into culture. According to a study by the Food […]
