Professional Certificate in IVD Regulatory Affairs Documentation Frameworks
-- ViewingNowThe Professional Certificate in IVD Regulatory Affairs Documentation Frameworks is a comprehensive course designed to meet the growing industry demand for experts in regulatory affairs. This certificate course emphasizes the importance of creating and managing documentation frameworks for In vitro Diagnostic (IVD) devices, which are essential for ensuring compliance with regulatory standards and guidelines.
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โข IVD Regulatory Affairs Overview
โข Understanding IVD Regulations and Standards
โข Documentation Requirements for IVD Devices
โข Designing Quality Management System for IVDs
โข Technical File Creation for IVD Devices
โข Clinical Evidence and Data Management in IVD Regulatory Affairs
โข IVD Labeling and Instructions for Use
โข Post-Market Surveillance and Vigilance in IVD Regulatory Affairs
โข Global Harmonization and IVD Regulations
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