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Sponsored byMonica Burt, MB&AKim Trautman, Medtech Regulatory ConsultantScott Shankle, Orchid Orthopedic SolutionsRodney Parker, Ph.D., Medtech Regulatory ConsultantNavigate the Global Audit Landscape with ConfidenceDID YOU KNOW THERE ARE 196 REGULATORY AUTHORITIES WORLD WIDE?Navigate the Global Audit Landscape with ConfidenceGlobal Audit Landscape and Best PracticesGlobal Audit Approaches6FDA QSIT - Subsystems of a Quality Management SystemDesign ControlsMaterial ControlsRecords, Documents, and Change ControlsEquipment and Facility ControlsProduction and Process ControlsCorrective andPreventive ActionsManagement7Risk ManagementMDSAP Audit ModelEU MDR: Article 10 – General requirementsArticle 10.1Design & Manufacture to (EU) 2017/745Article 10.2System for risk managementArticle 10.3Clinical evaluation & PMCFArticle 10.4Establish & maintain technical documentationArticle 10.6Declaration of conformityArticle 10.7System for Unique Device IdentificationArticle 10.8Document & record retent