Professional Certificate in Regulatory Affairs for Medical Imaging
-- ViewingNowProfessional Certificate in Regulatory Affairs for Medical Imaging: This certificate course is designed to meet the growing industry demand for professionals with a deep understanding of regulatory affairs specific to medical imaging. The course covers critical topics including regulatory pathways, quality systems, and global regulations, equipping learners with the essential skills to navigate the complex regulatory landscape of medical imaging.
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⢠Regulatory Framework for Medical Imaging
⢠Medical Device Classification and Regulation
⢠U.S. Food and Drug Administration (FDA) Regulations and Guidelines
⢠European Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR)
⢠Quality Management Systems for Medical Imaging
⢠Clinical Trials and Data Management for Medical Imaging Devices
⢠Labeling, Advertising, and Promotion Compliance for Medical Imaging
⢠Post-Market Surveillance and Vigilance for Medical Imaging Devices
⢠Risk Management in Medical Imaging Regulatory Affairs
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