Navigating ISO 13485, QMSR Alignment, and Manufacturer Accountability | Xcelrate UDI Webinar скачать в хорошем качестве

Navigating ISO 13485, QMSR Alignment, and Manufacturer Accountability | Xcelrate UDI Webinar

Navigating ISO 13485, QMSR Alignment, and Manufacturer Accountability | Xcelrate UDI Webinar Webinar Host: Joan Melendez, President, Xcelrate UDI The FDA’s new Quality Management System Regulation (QMSR), effective February 2026, aligns the U.S. regulatory framework with the international standard, ISO 13485:2016. This shift dramatically increases expectations for manufacturer accountability and, critically, places a new burden on hospitals to evaluate and enforce documentation compliance. This foundational session equips hospital and supply chain leaders with the regulatory backing to demand corrected, validated instructions and ensures your facility is not exposed to risk from non-compliant devices. What You Will Learn: The QMSR Deadline: Why February 2, 2026, is the most important compliance date for both manufacturers and hospitals. Hospital Empowerment: How the new regulations provide you with the mandate to reject devices with outdated, incomplete, or contradictory Instructions for Use (IFUs). Core ISO 13485 Requirements: A breakdown of the three key technical expectations: Use Limitations, Accessories, and Manufacturer Rep Accountability. UDI as the Compliance Mechanism: How UDI/GUDID data integrity is essential for traceability and linking devices to correct, validated documentation. Actionable Next Steps: The immediate steps your hospital must take for QMSR readiness, including UDI assessment and system harmonization. Actionable Checklists Included: We covered the critical areas for compliance enforcement. Download our checklists to start your internal assessment today: Hospital Operational Readiness & Value Analysis Checklist: Ensure device IFUs are compatible with your SPD/OR workflow and safety standards. Manufacturer / VAR Compliance Response Form: A template to formally verify documentation and regulatory status with your vendors. Visit our website to download these resources: [WEBSITE LINK PLACEHOLDER] Time Stamps: 0:00 - Introduction to QMSR and ISO 13485 3:45 - Why QMSR is an Operational Challenge for Hospitals 8:10 - The Mandate: Demanding Validated IFUs 15:22 - The Role of UDI in QMSR Compliance 20:05 - Review of the Manufacturer Accountability Checklist 25:30 - Final Hospital Readiness Steps 30:15 - Live Q&A and Key Takeaways Follow Xcelrate UDI: LinkedIn:   / xcelrate-udi   Website: https://www.xcelrateudi.com #QMSR #ISO13485 #FDACompliance #MedicalDevices #HealthTech #HospitalSafety #UDI #SupplyChain