MDR Study Application and Approval – New Coordinated Assessment

$179.00

Learn the new MDR rules for study application and approval process. The coordinated assessment procedure will streamline clinical investigations conducted in more than one EU Members State.

  • Course Type: Video Lessons
  • Language: English
  • Level: Beginner
  • Session: year 2021
  • Time: 0 - 1 Hour

Course Breakdown

Section Time
Introduction 00:01:57
Timelines & Applications 00:04:37
Electronic System 00:02:26
Coordinated Assessment 00:05:31
MDD vs MDR 00:02:26
Conclusion 00:00:46

Exam and Certifications

  • Final Test – MDR Study Application and Approval
  • Certification

Description

What I will learn?

This course will highlight the new application process for clinical investigations through the Electronic System under the MDR and relevant timelines. You will also get to know the new coordinated assessment procedure introduced for clinical trials to be conducted in more than one EU Member State.

Skills I will gain

  • Discover the novelties introduced by M-D-R, on the application for clinical investigations
  • Learn the Electronic System for clinical investigations
  • Understand the guidance on the new coordinated assessment procedure

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