Certificate in EU Medical Device Registration
-- ViewingNowThe Certificate in EU Medical Device Registration course is a comprehensive program designed to provide learners with the necessary skills to navigate the complex EU medical device regulatory landscape. This course emphasizes the importance of understanding EU regulations, including the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
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โข Introduction to EU Medical Device Regulation
โข Understanding the EU Medical Device Directive (MDD)
โข Transitioning to the Medical Device Regulation (MDR)
โข Classification of Medical Devices in the EU
โข EU MDR Conformity Assessment Procedures
โข EU MDR Technical Documentation Requirements
โข EU MDR Clinical Evaluation and Investigations
โข EU MDR Vigilance System and Post-Market Surveillance
โข EU MDR Notified Bodies and Their Role
โข EU MDR Labeling and UDI Requirements
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