Certificate in IVD Regulatory Affairs Compliance Strategies
-- ViewingNowThe Certificate in IVD Regulatory Affairs Compliance Strategies course is a comprehensive program designed to equip learners with the essential skills needed to navigate the complex world of in vitro diagnostic (IVD) regulatory affairs. This course is vital for professionals working in or seeking to enter the IVD industry, where regulatory compliance is paramount.
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โข IVD Regulations Overview
โข Understanding IVD Directive 98/79/EC
โข Essentials of ISO 13485 Quality Management System
โข IVD Classification and Risk Assessment
โข IVD Technical File Preparation
โข Understanding IVD Notified Bodies and Conformity Assessment Procedures
โข Post-Market Surveillance and Vigilance in IVDs
โข EU MDR and IVDR Transition Strategy
โข IVD Labeling, Instructions for Use, and Packaging Requirements
โข Global IVD Regulatory Harmonization and International Standards
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