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The designation certifies WuXi’s fitness for commercial manufacturing and quality management of drug-device combination products.
April 15, 2026
By: Patrick Lavery
Content Marketing Editor
WuXi Biologics has achieved International Organization for Standardization (ISO) 13485:2016 Medical Device Quality Management System certification with zero non-conformities. The designation certifies WuXi’s fitness for commercial manufacturing and quality management of drug-device combination products. Among the First in China ISO 13485:2016, a framework to ensure safety, effectiveness, and regulatory compliance, is recognized as the gold standard for quality management. WuXi Biologics ho...
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