Professional Certificate in IVD Regulatory Affairs Frameworks
-- ViewingNowThe Professional Certificate in IVD Regulatory Affairs Frameworks is a comprehensive course designed to meet the growing industry demand for experts in regulatory affairs for In Vitro Diagnostic (IVD) devices. This course emphasizes the importance of understanding global regulatory guidelines, quality management systems, and the development lifecycle of IVD devices.
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โข IVD Regulatory Affairs Fundamentals
โข Global IVD Regulations Overview
โข Understanding ISO 13485: Medical Devices Quality Management System
โข EU IVD Regulation (EU) 2017/746
โข IVD Classification Rules
โข US FDA IVD Regulations
โข Clinical Evidence Requirements for IVDs
โข Preparing IVD Technical Files
โข IVD Regulatory Submissions
โข Post-Market Surveillance & Vigilance in IVD Regulatory Affairs
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