Understanding ISO 14155:2020 Revisions

This webinar examines the new ISO 14155 medical device standard while exploring its implications for sponsors and investigators.

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About this Webinar

The International Organization for Standardization (ISO) 14155:2020 “Clinical investigation of medical devices for human subjects – Good clinical practice” guideline is an international standard for researching the safety and effectiveness of medical devices. The 2020 edition replaces the earlier version from 2011, with key changes in the responsibilities of sponsors and investigators. This webinar examines the principal revisions of the ISO standard with an eye toward determining how these changes impact the design and execution of clinical trials of medical devices.

Webinar Demo:

Release Date: August 11, 2022

Language Availability: English

Suggested Audiences: Compliance Professionals, Faculty and Post-Docs, General Counsel, Manufacturing Staff, Principal Investigators (PIs), Research Administrators, Sponsors

Organizational Subscription Price: $300 per year/per site or included as part of an annual subscription to our All Access Webinar Package
Independent Learner Price: $49 per person

Webinar Content

Understanding ISO 14155:2020 Revisions

Presented by: Liza Gordillo, MS – KLS Martin Group

Learning Objectives:

  • Describe the scope and purpose of ISO 14155:2020.
  • Detail the changes from ISO 14155:2011 to ISO 14155:2020.
  • Consider how the ISO 14155:2020 standard impacts sponsor and investigator responsibilities.

Recommended Use: Required
ID (Language): 20563 (English)

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