CITI Program Webinar Demo - Understanding ISO 14155:2020 Revisions
Автор: CITI Program
Загружено: 2022-09-20
Просмотров: 534
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.
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.
Presented by: Liza Gordillo, MS – KLS Martin Group
For access to the full webinar please visit: https://about.citiprogram.org/course/...
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