I3CGlobal provides expert guidance to help manufacturers meet the new FDA QMSR requirements with complete confidence. Their consultants streamline the transition from ISO 13485 alignment to full FDA Quality Management System Regulation compliance. With detailed gap assessments, documentation support, and audit preparation, I3CGlobal minimizes regulatory risks and ensures smooth approval pathways. Companies rely on their expertise to maintain quality, reduce errors, and achieve long-term compliance stability for U.S. market access.