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Fundamentals of the EU IVD Regulation

5-weeks | 1 hour per week

Future dates TBC

Online Academy

Module 1: Introduction to IVDR
Module 2: General Safety and Performance Requirements
Module 3: Documentations, Clinical Evidence and Clinical Performance of Devices in the EU
Module 4: Post-Market Surveillance (PMS) and Vigilance Responsibilities
Module 5: Compiling your Technical Documentation