New

A new revision – ISO 14155: 2020Clinical investigation of medical devices for human subjects
Good clinical practice

Gap analysis and implementation

Conducted by: Ms. Shoshana Friedman
Print version

Share a colleague:

Online - zoom

The standard ISO 14155 provides essential principles and guidance to any party involved in clinical investigations of medical devices. The third revision...Continue reading

The standard ISO 14155 provides essential principles and guidance to any party involved in clinical investigations of medical devices. The third revision of the standard, ISO 14155:2020 published in July 2020, introduces significant modifications, which align with regulatory changes in the medical device industry.

Among the modification are new requirements for:

  • continuous improvement
  • study design and statistics
  • implementation of risk based approach
  • definition of types of clinical investigations
  • how the standard applies to each of them

The course provides a comparison between the 2011 and 2020 revisions of ISO 14155 and presents practical guidance on how to implement the new requirements.

Close
Date:  16 March, 2021
Course location: Zoom Course
Duration: A half-day Course
Hours: 14:00 - 17:30
Credits:
Course Language: English

Course price: ₪975 + VAT
Early registration is Closed
Do you have a subscription? You deserve more

Have a question? We got all the answers

Issues to be covered

  • Background and history of ISO 14155
  • Position of ISO 14155 in the regulation of medical devices
  • Overview of differences between ISO 14155:2020 and ISO 14155:2011
  • Implementation of ISO 14155:2020 in ongoing and future clinical studies

Who should attend

Individuals who are involved in designing and executing clinical studies of medical devices

Benefits to the Participants

Participants in this course will:

  • Learn about the similarities and differences between the 2nd and 3rd edition of ISO 14155
  • Understand the role of ISO 14155 in the context of medical device regulation
  • Get tools to identify gaps in their current clinical study processes

About The Lecturer

Shoshana Friedman
Shoshana (Shosh) Friedman is the President and CEO of ProMedoss,
Read more

Leave a Reply