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Fundamentals of EU Regulations for Medical Devices

5-week online course | 2 hours per week

2 March - 10 April 2020

Online Academy

Module 1: Introduction to Medical Devices and the New MDR and IVDR
Module 2: Borderlines and classification
Module 3: General safety and performance requirements
Module 4: Clinical evaluations and investigations
Module 5: Risk assessment and management
Module 6: Technical documentation
Module 7: Quality Management System
Module 8: Conformity assessment routes
Module 9: PMS and vigilance