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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โข Global IVD Regulatory Landscape
โข Quality Management System (QMS) for IVDs
โข IVD Regulation: EU MDR & IVDR
โข IVD Regulation: US FDA
โข IVD Regulation: China NMPA
โข Clinical Evidence and Evaluation for IVDs
โข IVD Post-Market Surveillance and Vigilance
โข Regulatory Submissions and Approvals for IVDs
โข Global Harmonization and Convergence in IVD Regulation
โข Ethics and Human Factors in IVD Regulatory Affairs
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