ISO 14155: Obligations of Sponsors and Monitors for Medical Device Trials

ISO 14155 is intended to be applied worldwide to clinical investigations of medical devices in order to fulfill the various national, regional, and international regulatory requirements. Topics in this course include: Ethics, CIP, Investigator’s Brochure, Informed Consent, Other Documents, Sponsors, and Monitors. After completing this course, the learner will be able to identify the specific requirements of ISO 14155. The learner will also be able to recognize the roles and responsibilities of sponsors and monitors in clinical investigations of medical devices.

After this course learners will be able to identify the specific requirements of iso 14155. recognize the roles and responsibilities of sponsors and monitors in clinical investigations of medical devices.