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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⢠IVD Regulatory Affairs Management Overview
⢠Understanding the IVD Medical Device Regulation (MDR) &
In Vitro Diagnostic Regulation (IVDR)
⢠Global Harmonization Task Force (GHTF) & International Medical Device
Regulatory Forum (IMDRF)
⢠Quality Management System (QMS) for IVDs
⢠Clinical Evidence and Evaluation for IVDs
⢠IVD Labeling, Instructions for Use (IFU), and Promotional Materials
⢠Post-Market Surveillance & Vigilance in IVD Regulatory Affairs
⢠IVD Regulatory Affairs Management in Emerging Markets
⢠Strategic Approach to IVD Regulatory Affairs Management
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