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Compliance with the FDA Quality System Regulation (QSR / 21 CFR Part 820) is critical for medical device manufacturers to ensure product safety, effectiveness, and regulatory adherence. The QSR outlines requirements for a Quality Management System (QMS), covering design controls, production, process validation, and corrective actions. At XPRO AMERICA, we [...]
Accurate and compliant device labeling is critical to ensure safety, regulatory adherence, and market access in the United States. Under 21 CFR Part 801, the FDA requires medical devices to have labels that clearly communicate intended use, instructions, and risk information. Compliance with Unique Device Identification (UDI) regulations further enhances [...]
Ensuring FDA import compliance is essential for foreign medical device manufacturers and U.S. importers to avoid detention, refusal, or penalties at U.S. ports. The FDA enforces strict regulations on medical devices entering the U.S., including establishment registration, device listing, labeling, and prior notice requirements. At XPRO AMERICA, we provide comprehensive [...]