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The New European UDI System Part II

$49.00

The second part of New European UDI System Video Course is designed to help you discover UDI Implementation, Medical Device Registration, and functional specifications. This course also covers the data dictionary for UDI as well as the MDCG guidelines on UDI-DI and for special cases of device registration.

Description

Why take this course

The Unique Device Identification Video Course is designed to help further expand your knowledge of the UDI system.

What I will learn

This course will highlight the UDI system and will facilitate easier traceability of medical devices and quick identification of the specific user. This system significantly enhances the effectiveness of the post-market safety-related activities for devices and allow for better monitoring by competent authorities.

Skills I will gain

  • Discover Unique Device Identification (UDI) System
  • Explore the UDI structure and requirements
  • Learn key the timelines for registration of device data for EUDAMED
  • Understand the difference between UDI in Europe vs the USA

 

TOPICS

  • Introduction (00:01:18)
  • UDI Implementation: Where are we? (00:00:32)
  • Where and How to register your medical device (00:08:05)
  • Examples of UDI Software for medical devices (00:02:28)
  • EU Commission Eudamed Functional specifications for UDI (00:00:29)
  • UDI Data dictionary published by EU Commission (00:01:09)
  • Basic UDI-DI attributes published by EU Commission (00:00:27)
  • MDCG 2019-4 Timelines for registration of device data elements in EUDAMED (00:00:45)
  • MDCG Guidance on basic UDI-DI and changes to UDI-DI (00:02:29)
  • MDCG Guidelines for special cases of device registration (00:06:25)

  • Final Quiz – MDR The New European UDI System (Part II)
  • Certification

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