Investigational Devices

Investigators at UMMS are required to describe the control and management plan of test articles in the Investigator Study Plan.  Please see the following for information and guidance about the proper control and management of Investigational Devices in clinical research, including the coordination and management of investigational devices requiring a power source in the clinical environment.

[HRP-913 Standard Operating Procedure for Investigational Devices
[HRP-914 2014 Medical Device Management Plan]
[CE001, Medical Device Electrical Inspection Procedure 2011]