Masterclass Certificate in IVD Regulatory Affairs Documentation
-- ViewingNowThe Masterclass Certificate in IVD Regulatory Affairs Documentation course is a comprehensive program that equips learners with critical skills in the regulatory affairs field, specifically for In Vitro Diagnostic (IVD) devices. This course highlights the importance of producing accurate and compliant documentation, which is essential for ensuring IVD device safety and effectiveness.
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โข IVD Regulatory Affairs Overview
โข Understanding IVD Directives and Regulations
โข Classification of In Vitro Diagnostic Devices
โข Essential Requirements for IVD Devices
โข Designing and Implementing Quality Management Systems
โข Technical File Preparation for IVD Devices
โข Clinical Evidence and Performance Evaluation
โข IVD Notified Body Engagement and Conformity Assessment
โข Post-Market Surveillance and Vigilance for IVD Devices
โข Global Harmonization and International IVD Regulations
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