🚨 Special Discount🚨 on EU IVDR 2017 746 Practitioner

n completion, successful Learners will have the knowledge needed to:

1. Explain the history, purpose, and structure of the EU IVDR, and the key terminology used throughout the regulation
2. Identify the types of the device covered by the EU IVDR, the rules for classification, and the routes to conformity
3. Describe the obligations of the economic operators and the PRRC
4. Describe the General Safety & Performance Requirements
5. Outline the requirements for Performance evaluation and Performance studies
6. Explain the Post Market Surveillance and Vigilance reporting requirements
7. Describe the contents of the Technical Documentation and explain the Unique Device Identifier requirements