Medical Device Contract Manufacturing

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Designed from the ground up to foster a cohesive, integrated, and collaborative environment, the world-class manufacturing facility at Pro-Dex is FDA QSR compliant, and adheres to EU regulatory guidelines with ISO 13485, CE and CMDCAS certifications. Equipped with proven RA/QA expertise and a comprehensive Quality Management System (QMS), Pro-Dex's Medical Device Manufacturing Services ensure excellence through controlled product designs, manufacturing processes, document controls, and CAPA systems.

With Pro-Dex manufacturing services, customers can rest assured that each manufactured product complies with all applicable regulatory product guidelines and system standards, thus ensuring full compliance to specifications and medical device regulations.

Published in: Health & Medicine
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