Executive Development Programme in IVD Regulatory Affairs Management Strategies
-- ViewingNowThe Executive Development Programme in IVD Regulatory Affairs Management Strategies certificate course is a comprehensive program designed to equip learners with critical skills in managing regulatory affairs for In Vitro Diagnostic (IVD) devices. This course highlights the importance of regulatory compliance in the IVD industry and the role of effective management strategies in driving business success.
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⢠IVD Regulatory Affairs Management
⢠Understanding the IVD Regulatory Landscape
⢠Global IVD Regulations (e.g., EU IVDR, US MDR, China NMPA)
⢠Compliance Strategies for IVD Manufacturers
⢠Quality Management Systems in IVD Regulatory Affairs
⢠Clinical Evidence and Data Requirements for IVDs
⢠Post-Market Surveillance and Vigilance in IVD Regulatory Affairs
⢠Risk Management in IVD Regulatory Affairs
⢠IVD Labeling, Packaging, and Distribution
⢠Strategic Planning for IVD Regulatory Affairs
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