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With the rising global demand for U.S. FDA compliance, XPRO America an established provider of USFDA registration and regulatory consulting has taken a bold step forward by launching its services on top freelance platforms: Fiverr and Upwork. Traditionally operating through its website consultancy model, XPRO America specializes in guiding international [...]
After obtaining 510(k) clearance, medical device manufacturers must maintain strict compliance with the FDA Quality System Regulation (QSR, 21 CFR Part 820). FDA inspections can occur at any time and focus on ensuring that your quality management system, production processes, and corrective actions meet regulatory requirements. Being unprepared can result [...]
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 [...]
Compliance with Current Good Manufacturing Practices (cGMP) is mandatory for all pharmaceutical manufacturers, repackers, relabelers, and distributors who want to market drug products in the United States. Governed under 21 CFR Parts 210 and 211, cGMP regulations establish the minimum requirements for methods, facilities, and controls used in the manufacturing, [...]