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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⢠IVD Regulatory Affairs Overview
⢠Understanding IVD Regulations and Standards
⢠Documentation Requirements for IVD Devices
⢠Designing Quality Management System for IVDs
⢠Technical File Creation for IVD Devices
⢠Clinical Evidence and Data Management in IVD Regulatory Affairs
⢠IVD Labeling and Instructions for Use
⢠Post-Market Surveillance and Vigilance in IVD Regulatory Affairs
⢠Global Harmonization and IVD Regulations
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