Professional Certificate: EU MDR Essentials
-- ViewingNowThe Professional Certificate: EU MDR Essentials is a course designed to provide in-depth knowledge of the European Union Medical Device Regulation (EU MDR). This regulation, implemented in May 2021, replaced the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD).
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โข EU MDR
โข MDR Timeline and Transition
โข MDR Scope and Classification
โข MDR Technical Documentation Requirements
โข MDR Quality Management System
โข MDR Clinical Evaluation and Post-Market Clinical Follow-up
โข MDR Vigilance and Post-Market Surveillance
โข MDR Notified Bodies and Designation Process
โข MDR UDI and Eudamed Database
โข MDR Economic Operators and Their Obligations
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