Global Certificate in IVD Regulatory Compliance
-- ViewingNowThe Global Certificate in IVD Regulatory Compliance course is a professional development program designed to equip learners with the necessary skills to navigate the intricate world of in vitro diagnostic (IVD) device regulation. This course is crucial in an industry where strict compliance with regulatory standards is paramount.
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⢠Global IVD Regulations Overview
⢠Quality Management System (QMS) for IVD
⢠Risk Management for IVD
⢠Design Control and Verification & Validation for IVD
⢠IVD Labeling and Instructions for Use
⢠Post-Market Surveillance and Vigilance for IVD
⢠Clinical Evidence and Performance Evaluation for IVD
⢠Regulatory Pathways for IVD
⢠Import and Export Controls for IVD
⢠Global Harmonization and Convergence in IVD Regulations
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