Masterclass Certificate in IVD Regulatory Affairs Management Essentials
-- ViewingNowThe Masterclass Certificate in IVD Regulatory Affairs Management Essentials is a comprehensive course designed to empower learners with the necessary skills to thrive in the In Vitro Diagnostic (IVD) industry. This course is of paramount importance as it provides a solid understanding of the complex regulatory landscape, ensuring compliance with IVD regulations and standards.
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โข IVD Regulations Overview
โข Understanding IVD Directive 98/79/EC
โข ISO 13485 Quality Management System for IVDs
โข IVD Classification and Notified Body Selection
โข Technical File Creation and Review
โข EU MDR & IVDR Implementation and Transition Planning
โข Clinical Evidence Requirements for IVDs
โข Post-Market Surveillance and Vigilance in IVDs
โข Global IVD Regulations: FDA, Chinese IVD Regulations, etc.
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