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In Vitro Device Regulation – Masterclass

$79.00

This lecture presents the roadmap of the new European regulation for in vitro diagnostic medical devices and provides an orientation to navigate all the key changes. Learn all you need to know for a successful transition to the new legislative framework. Easy guidelines are provided to get ready on time!

Description

This lecture presents the roadmap of the new European regulation for in vitro diagnostic medical devices and provides an orientation to navigate all the key changes. Learn all you need to know for a successful transition to the new legislative framework. Easy guidelines are provided to get ready on time!

 

TOPICS

  • Introduction (00:01:35)
  • Regulation Changes (00:00:36)
  • IVDR Structure and Key Changes (00:02:06)
  • Scope and Definitions (00:01:56)
  • Specifications (00:01:13)
  • Rules for Economic Operators (00:01:00)
  • Regulatory Compliance (00:01:27)
  • Requisite Expertise (00:00:30)
  • Unique Device Identification (UDI) (00:03:11)
  • EUDAMED (00:01:11)
  • Registration for Economic Operators (00:01:21)
  • Classification (00:03:01)
  • Risk Classification (00:01:14)
  • Conformity Assessment (00:05:11)
  • Performance Evaluation (00:04:40)
  • PMS and Vigilance (00:02:19)
  • Technical Documentation (00:01:12)
  • Risk Management (00:04:56)
  • Timelines and Grace Period (00:03:05)
  • Data Protection and Guidance (00:00:30)
  • Corrigenda (00:01:58)
  • IVDR Impact on Industry (00:02:00)

  • Final Test – European IVDR Roadmap
  • Certification

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