Featuring Speaker
Yuan Xu, Director of Quality and Regulatory at Vivalink
Solution-Driven QARA Consultant with a specialized focus on QMS and GxP Compliance for Medical Device/IVD/Biotech industries. 10+ experience of End-to End Quality lifecycle support, from Design Control, Clinical Study, Product Launch to Post-market Quality. Proven track record in strategic planning, QMS building, Regulatory Inspection to ensure adherence to ISO 13485, 21 CFR 210/211, 820, MDSAP, ICH and EU Regulations. Yuan currently hold certifications of ISO Lead Auditor, ASQ- Six Sigma Black Belt, CQE, CQA, and RAPS-RAC.
About This Event
The FDA is moving from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR), aligning more closely with ISO 13485 standards. Whether your organization is already ISO-certified or not, it’s vital to adjust the QMS to meet 2026 Compliance deadline. This session will provide a comprehensive overview of key components of the QMSR, highlight critical updates from QSR and difference from ISO 13485, and share best practices for achieving compliance.