Performance Evaluation of IVD Medical Devices

Performance Evaluation of IVD Medical Devices

590 €

Get familiar with the latest requirements of performance evaluation – quickly, clearly, and online!

Objective evidence-based performance evaluation became a central element of the conformity assessment of in vitro diagnostic medical devices with the introduction of the IVDR. During this course, you will gain an understanding of the stricter requirements for performance evaluation based not only on the IVDR itself, but also on related guidance documents and best practices.

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Information

The course material is available anytime and from anywhere through an interactive e-learning platform, allowing you to learn entirely at your own pace.

Your knowledge will be assessed through online quizzes, and upon successful completion, you will receive a certificate confirming the completion of the training.

✓ Author: Dr. Katalin Jakab Tauber, MD (Clinical Expert, NoBoVersum Zrt.)
✓ Access to the course material for 3 months from the date of purchase
✓ 30-page educational material explaining the current requirements for the performance evaluation of IVD medical devices in a clear and practical way
✓ Online quizzes to reinforce learning
✓ Certificate of completion with assessment results

Do you have questions about the course content?

Simply send us an email at info@noboversum.hu and we will forward your question to the expert for a professional response.

Topics

IVDR Performance Evaluation Requirements and Process
  • Meaning of terms used in performance evaluation
  • The performance evaluation process
Performance Evaluation Planning Process and Documentation
  • Performance Evaluation Plan (PEP)
    • Clinical Performance Evaluation Plan
    • Analytical Performance Evaluation Plan
    • Scientific Validity
  • Post-Market Performance Follow-up Plan
Performance Evaluation Report (PER)
  • The role of the Performance Evaluation Report within the evaluation process
  • Content requirements
  • PER sub-reports
    • Scientific Validity Report
    • Analytical Performance Report
    • Clinical Performance Report
Post-Market Performance Follow-up (PMPF)
  • Relationship between PMS and performance evaluation
  • Steps of post-market performance follow-up
  • Content requirements of the PMPF Plan
  •  
  • Relevant Standards

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