Masterclass Certificate in IVD Regulatory Affairs Compliance Strategies
-- ViewingNowThe Masterclass Certificate in IVD Regulatory Affairs Compliance Strategies is a comprehensive course that equips learners with critical skills in regulatory affairs compliance for In Vitro Diagnostic (IVD) devices. This course is crucial in the rapidly evolving medical device industry, where regulatory compliance is paramount.
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⢠IVD Regulations and Compliance Overview
⢠Global IVD Regulatory Landscape
⢠Quality Management System for IVDs
⢠IVD Labeling, Advertising, and Promotion Compliance
⢠Clinical Evidence and Performance Evaluation
⢠Post-Market Surveillance and Vigilance in IVDs
⢠EU IVDR and In-Vitro Diagnostic Medical Device Regulation
⢠US FDA Regulations and Compliance for IVDs
⢠Risk Management in IVD Development and Manufacturing
⢠Strategies for Effective IVD Regulatory Affairs Management
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