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In Vitro Medical Device Regulation Roadmap (IVDR)

$49.00

This course describes general principles and gives practical advice on how to plan and prepare for the IVDR.

Description

In this course, we will cover all the necessary regulatory references. We will discuss in detail article 56 of IVDR. Moreover, you will learn about general safety and performance requirements. We will also explain what is the performance evaluation and step by step we will guide you through its components. At the end, we will highlight your periodic deliverables so you will be aware on what and when needs to be updated.

 

TOPICS

  • Introduction to IVDR (00:02:08)
  • Key Changes to IVDR (00:03:02)
  • Guidance and Risk Classification (00:01:25)
  • IVDR Timelines and Grace Period (00:01:30)
  • Impact on Industry (00:01:03)

  • Final Test
  • Course evaluation survey
  • Certification

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