Executive Development Programme in Medical Device Regulatory Decision-Making
-- ViewingNowThe Executive Development Programme in Medical Device Regulatory Decision-Making certificate course is a comprehensive programme designed to empower professionals with the essential skills needed to excel in the rapidly evolving medical device industry. This course highlights the importance of regulatory decision-making, equipping learners with the knowledge and tools to navigate complex regulatory landscapes and make informed decisions that drive innovation and growth.
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โข Regulatory Affairs and Compliance for Medical Devices
โข Understanding Global Medical Device Regulations
โข Quality Management Systems in Medical Device Manufacturing
โข Clinical Evaluation and Investigational Device Trials
โข Medical Device Classification and Risk Management
โข Post-Market Surveillance and Vigilance
โข European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
โข U.S. Food and Drug Administration (FDA) Regulations for Medical Devices
โข Strategic Regulatory Planning and Decision-Making in Medical Device Development
โข Global Medical Device Harmonization and Convergence Trends
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