Executive Development Programme in IVD Regulatory Affairs Management Essentials
-- ViewingNowThe Executive Development Programme in IVD Regulatory Affairs Management Essentials is a certificate course designed to empower professionals with the necessary skills to navigate the complex regulatory landscape of the In Vitro Diagnostic (IVD) industry. This programme is crucial in the current climate, where there is increasing demand for experts who can ensure compliance with intricate and ever-evolving regulations.
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โข IVD Regulatory Affairs Management Overview
โข Understanding the IVD Medical Device Regulation (MDR) &
In Vitro Diagnostic Regulation (IVDR)
โข Global Harmonization Task Force (GHTF) & International Medical Device
Regulatory Forum (IMDRF)
โข Quality Management System (QMS) for IVDs
โข Clinical Evidence and Evaluation for IVDs
โข IVD Labeling, Instructions for Use (IFU), and Promotional Materials
โข Post-Market Surveillance & Vigilance in IVD Regulatory Affairs
โข IVD Regulatory Affairs Management in Emerging Markets
โข Strategic Approach to IVD Regulatory Affairs Management
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