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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⢠IVD Regulatory Affairs Overview
⢠Understanding IVD Directives and Regulations
⢠Classification of In Vitro Diagnostic Devices
⢠Essential Requirements for IVD Devices
⢠Designing and Implementing Quality Management Systems
⢠Technical File Preparation for IVD Devices
⢠Clinical Evidence and Performance Evaluation
⢠IVD Notified Body Engagement and Conformity Assessment
⢠Post-Market Surveillance and Vigilance for IVD Devices
⢠Global Harmonization and International IVD Regulations
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