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MDR FOR DUMMIES

$49.00

This lecture presents the new European regulation for medical devices and provides an easy to learn overview of all the key changes. Learn all you need to know for a successful transition to the new legislative framework.

Description

Why take this course

There are significant changes that affect all companies that produce medical devices and wish to sell them in Europe.The new medical device regulation has introduced some new aspects and more complex rules will impact manufacturers, operators, health professionals and the public.

What I will learn

  • MDR Structure and Key changes to the Regulation
  • MDR Scope and Definitions
  • Responsibilities and obligations of Economic Operators
  • EUDAMED and UDI
  • Device classification and Conformity assessment
  • Clinical evaluation and investigations
  • Surveillance and Vigilance
  • Skills I will gain

    This course will help you:

  • Understand the principles, framework and procedures described in MDR
  • Learn the scope and definitions followed by economic operators
  • Learn how MDR regulates the manufacturing and marketing of medical devices in the EU
  • Understand clinical evaluation and investigations along with surveillance and vigilance of medical devices.
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    TOPICS

    • Introduction and Meditrial Tools (00:01:35)
    • MDR for Dummies (00:02:27)
    • Learn and Comply (00:06:57)
    • What’s New (00:06:01)
    • When to be ready (00:05:39)
    • Impact on Industry (00:03:00)

    • Final Test – MDR for Dummies
    • Certification

    Additional information

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