ISO 14155 2020 Clinical Trial from Start to Finish


This tutorial provides an accurate overview of the main changes introduced by ISO 14155: 2020 for the Clinical Trial process. The clinical trial’s process is described from the beginning to the end: Planning, Conduct and Closeout.

  • Course Type: Video Lessons
  • Language: English
  • Level: Advanced
  • Session: year 2020
  • Time: 0 - 1 Hour
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Course Breakdown

Section Time
Introduction 00:01:09
Regulatory Information 00:08:07
Submission Preparation 00:05:29
Acceptance Review 00:06:57
AI Request and MDUFA 00:06:08
Conclusion 00:08:12

Exam and Certifications

  • Final Test – ISO 14155 2020 Clinical Trials from Start to Finish
  • Certification


What I will learn?

This tutorial provides an overview of the main changes introduced by ISO 14155: 2020 on different steps of the clinical investigation:

  • Understand what is a 510(k) submission
  • Explore the types of 510(k) submissions
  • Discover the preparation of the submission and submission review procedure
  • Learn who should submit a 510(k)
  • Understand when a 510(k) it would not be required

Skills I will gain

You will be able to clearly understand the new requirements and identify those already provided by ISO 14155:2011 and confirmed by the new version of the standard.


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