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Description
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.
Audience
Compliance Professionals, Faculty and Post-Docs, General Counsel, Manufacturing Staff, Principal Investigators (PIs), Research Administrators, Sponsors
Meet the Presenter
Liza Gordillo, MS – KLS Martin Group
Liza serves as Regulatory Affairs Project Manager at KLS Martin Group. Currently, she authors 510(k) submissions for medical devices undergoing the design and development process. Liza has a BS in Biomedical Engineering at Florida International University and MS in Industrial Engineering at the University of Miami.
