Certificate in Regulatory Affairs for Medical Devices
-- ViewingNowThe Certificate in Regulatory Affairs for Medical Devices is a comprehensive course that equips learners with critical skills necessary for success in the medical device industry. This program emphasizes the importance of regulatory compliance, ensuring that medical devices are safe, effective, and meet all required standards and regulations.
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⢠Regulatory landscape for medical devices
⢠Medical device classifications and their implications
⢠Design and development controls for medical devices
⢠Quality management systems in medical device manufacturing
⢠Regulatory compliance for medical device labeling and packaging
⢠Clinical trials and performance data for medical devices
⢠Post-market surveillance and vigilance for medical devices
⢠Global harmonization and international regulatory standards
⢠European Union (EU) Medical Device Regulation (MDR) compliance
⢠United States (US) Food and Drug Administration (FDA) regulatory affairs
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