自信地驾驭全球审计形势.pdf

1、Sponsored byMonica Burt,MB&AKim Trautman,Medtech Regulatory ConsultantScott Shankle,Orchid Orthopedic SolutionsRodney Parker,Ph.D.,Medtech Regulatory ConsultantNavigate the Global Navigate the Global Audit Landscape with Audit Landscape with ConfidenceConfidenceDID YOU KNOW THERE ARE 196 REGULATORY

2、AUTHORITIES WORLD WIDE?Navigate the Global Audit Navigate the Global Audit Landscape with ConfidenceLandscape with ConfidenceGlobal Audit Landscape and Best PracticesGlobal Audit Global Audit ApproachesApproaches6FDA QSIT-Subsystems of a Quality Management SystemDesign ControlsMaterial ControlsRecor

3、ds,Documents,and Change ControlsEquipment and Facility ControlsProduction and Process ControlsCorrective andPreventive ActionsManagement7Risk ManagementMDSAP Audit MDSAP Audit ModelModelEU MDR:Article 10 EU MDR:Article 10 General requirementsGeneral requirementsArticle 10.1Design&Manufacture to(EU)2

4、017/745Article 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 retention obligationsArticle 10.9Maintaining conf

5、ormity to(EU)2017/745 relating to changesEU MDR:Article EU MDR:Article 10(9)Components 10(9)Components Basic Quality Basic Quality Management Management System System RequirementsRequirementsIntegration of QMS and RMA with New Global Regulatory ExpectationsDesign&Development ProcessPost Production(C

6、omplaints&Vigilance)Risk ManagementChange Control ProcessSupplier ManagementChanges to existing designs or processesField PerformanceAssessed RisksDesign inputInput for vigilance Input on how change may affect riskChanges to existing designs or processesInput on process risks to manageMaturity Model