Certificate in Medical Device Regulatory Strategy
-- ViewingNowThe Certificate in Medical Device Regulatory Strategy course is a comprehensive program designed to provide learners with a deep understanding of the complex regulatory landscape in the medical device industry. This course highlights the importance of regulatory compliance and showcases the growing industry demand for professionals who can navigate this intricate field.
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⢠Regulatory Affairs Overview
⢠Medical Device Classification and Regulation
⢠Global Regulatory Strategies for Medical Devices
⢠U.S. Food and Drug Administration (FDA) Regulations and Compliance
⢠European Union Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR)
⢠Quality Management Systems for Medical Devices
⢠Clinical Evaluation and Investigational Device Exemptions (IDE)
⢠Medical Device Labeling, Advertising, and Promotion Compliance
⢠Post-Market Surveillance and Vigilance
⢠Regulatory Affairs for Combination Products
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