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Medical Devices

Obligations of Investigators in Conducting Medical Device Trials

About the Course

This online course addresses the requirements for conducting clinical trials for investigational premarket medical devices. It provides an overview of the clinical investigator’s general and specific obligations to protect human subjects while providing valid data that sponsors may submit to regulatory authorities for approval. This eLearning course also introduces documentation and reporting requirements, the inspection process, and the consequences for failure to comply with good clinical practice. It concludes with suggestions for improving compliance.