EU MDR 2017 745 Practitioner Training

EU MDR 2017 745 Practitioner Training

Our Online EU MDR 2017 745 Training Course can take you through the new European Medical Device Regulation, not just from an industry perspective, but also from a Notified Body perspective, which means you get the benefit of understanding what both sides are looking for. 20 hours - eLearning. Advance member discounted price $1015.75.

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About this course

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

  1. Explain the history, purpose, and structure of the EU MDR, and the key terminology used throughout the regulation
  2. Identify the types of devices covered by the EU MDR and the rules for classifying these devices
  3. Describe the obligations of the economic operators and the PRRC
  4. Describe the General Safety & Performance Requirements and the key features of a risk management system based on ISO 14971
  5. Describe the contents of the Technical Documentation and the requirements for Post Market Surveillance, Vigilance, and Clinical Data
  6. Explain the Unique Device Identifier requirements and the relationship with Eudamed

Curriculum20 hours

  • Introduction
  • Course Sign up
  • Conclusion

About this course

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

  1. Explain the history, purpose, and structure of the EU MDR, and the key terminology used throughout the regulation
  2. Identify the types of devices covered by the EU MDR and the rules for classifying these devices
  3. Describe the obligations of the economic operators and the PRRC
  4. Describe the General Safety & Performance Requirements and the key features of a risk management system based on ISO 14971
  5. Describe the contents of the Technical Documentation and the requirements for Post Market Surveillance, Vigilance, and Clinical Data
  6. Explain the Unique Device Identifier requirements and the relationship with Eudamed

Curriculum20 hours

  • Introduction
  • Course Sign up
  • Conclusion

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