征服MDR迷宫专家洞察和真实世界的例子

Sponsored byEhab Esmail, OrthofixMatthias Fink, M.D., AKRA Team Sandeep Ramineni, Ph.D., TÜV SÜD (slides not available)Conquer the MDR Maze: Expert Insights & Real-World ExamplesConquer the MDR Maze: Expert Insights & Real-World ExamplesEhab EsmailSenior Vice PresidentGlobal Quality, Regulatory and Clinical AffairsPresidentBoard MemberAGENDAMDR Requirements – Remediation?Equivalence – Medical DevicesSignificant Change vs. Substantial ChangeFDA vs. CE MarkPerson Responsible for Regulatory Compliance (PRRC) 1. Gap Analysis and Project PlanningProject Management2. Enhanced Clinical EvidenceClinical ResearchPost-Market Surveillance3. Technical Documentation UpdateProduct Development Quality Assurance4. UDI Implementation and EUDAMED RegistrationOperations and Manufacturing IT Systems 5. Reclassification of DevicesProduct Development 6. Quality Management System (QMS) UpdateQuality Assurance 7. Supply Chain and Economic Operators ComplianceOperations and ManufacturingSales and Marketing & T