IVDR ISO 20916:2019


This lecture describes the key changes regarding post market surveillance and what companies should do to meet their new obligations. After the course you can take a final test to receive your certification. Enjoy!

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

Section Time
Introduction 00:01:02
What is ISO 20916:2019 00:00:55
Scope and Normative References 00:01:05
Terms, Definitions, and Ethical Considerations 00:01:51
Clinical Performance Studies: Planning, Conduct & Close-out 00:07:35

Exam and Certifications

  • Final Test – ISO 20916:2019
  • Certification


What I will learn?

This course will will guide you through ISO 20916 standard. You will learn it’s main topics and definitions. We will give you an overview of ethical principles and we will describe planning, conduct and close-out of clinical performance studies.

Skills I will gain

  • Discover ISO 20916:2019
  • Explore the main principles of ISO 20916:2019
  • Learn how to ensure the conduct required for clinical performance studies
  • Comprehend and apply the requirements of ISO 20196:2019 to In Vitro diagnostic medical device clinical studies


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