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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โข Regulatory Framework for Medical Imaging
โข Medical Device Classification and Regulation
โข U.S. Food and Drug Administration (FDA) Regulations and Guidelines
โข European Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR)
โข Quality Management Systems for Medical Imaging
โข Clinical Trials and Data Management for Medical Imaging Devices
โข Labeling, Advertising, and Promotion Compliance for Medical Imaging
โข Post-Market Surveillance and Vigilance for Medical Imaging Devices
โข Risk Management in Medical Imaging Regulatory Affairs
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