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New ISO 14155 2020 Key Changes for your Trial


This recorded video-lecture by Dr. Monica Tocchi, who contributed to the development of international standard ISO 14155 for clinical trials. This introductory course describes the key changes that affect pre-market studies and post-market trials for medical devices.


Why take this course

This Meditrial Video Course is designed to support manufacturers to run clinical trials suitable for worldwide acceptance in line with the standard ISO 14155 2020. Find out what is new in ISO 14155 2020 and what is the impact on the industry and your job.

What I will learn

What are the innovations in medical device trials?

ISO 14155 2020 Outline

Key changes introduced in ISO 14155 2020
What is the impact on industry and effect on your job?

Skills I will gain

  • Become familiar with structure and topics covered by ISO 14155 2020
  • Get an understanding of the changes introduced in ISO 14155 2020 compared to ISO 14155 2011
  • Learn how to plan, conduct and close a clinical trial according to ISO 14155 2020



  • Introduction (00:00:25)
  • Why learn about this standard (00:02:30)
  • Technical Committee (00:01:57)
  • Innovation in 2020 edition (00:03:03)
  • Key Changes (00:03:31)
  • Impact on Industry (00:04:21)

  • Final Test – New ISO 14155 2020 Key Changes for your Trial
  • Certification

Additional information

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