Global Certificate in IVD Regulatory Affairs Management Frameworks
-- ViewingNowThe Global Certificate in IVD Regulatory Affairs Management Frameworks course is a comprehensive program designed to meet the growing industry demand for experts in medical device regulation. This course emphasizes the importance of understanding global regulatory affairs management frameworks specifically for In Vitro Diagnostic (IVD) devices.
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⢠Global IVD Regulatory Landscape
⢠Quality Management System (QMS) for IVDs
⢠IVD Regulation: EU MDR & IVDR
⢠IVD Regulation: US FDA
⢠IVD Regulation: China NMPA
⢠Clinical Evidence and Evaluation for IVDs
⢠IVD Post-Market Surveillance and Vigilance
⢠Regulatory Submissions and Approvals for IVDs
⢠Global Harmonization and Convergence in IVD Regulation
⢠Ethics and Human Factors in IVD Regulatory Affairs
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