Masterclass Certificate in Medical Device Regulatory Affairs Management
-- ViewingNowThe Masterclass Certificate in Medical Device Regulatory Affairs Management is a comprehensive course designed to equip learners with critical skills in navigating the complex regulatory landscape of the medical device industry. This program emphasizes the importance of regulatory compliance and strategic planning, making it essential for professionals pursuing or advancing their careers in this field.
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⢠Regulatory Landscape and Compliance for Medical Devices
⢠Medical Device Classification and Product Code Selection
⢠Quality System Regulations (QSR) and ISO 13485 Compliance
⢠Design Control, Risk Management, and Post-Market Surveillance
⢠Medical Device Submissions: 510(k), PMA, and De Novo Pathways
⢠Global Harmonization and International Regulatory Affairs
⢠Labeling, Advertising, and Promotion Compliance for Medical Devices
⢠Clinical Trials and Investigational Device Exemptions (IDEs)
⢠Post-Market Compliance and Adverse Event Reporting
⢠MDR/IVDR Implementation and Impact on Regulatory Affairs
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