Program Overview

Good Clinical Practice for Medical Devices (ISO14155) - 001CPD Course Description ## Good Clinical Practice for Medical Devices (ISO14155) - 001CPD Course Description ## Course Overview The Good Clinical Practice for Medical Devices (ISO14155) - 001CPD course is designed for Investigators, Research Nurses, and individuals with research roles who are planning to conduct or are actively engaged in conducting clinical investigations of investigational medical devices. This course is provided by the Quality Department of the HRB-Clinical Research Facility University College Cork. ### Course Contents The course covers the following topics: - Medical Device Definitions and Classification - CE Mark, Notified Bodies - EU Device legislation - Planning and Conduct of Device Investigations - Documentation required for Clinical Investigations - PI Responsibilities - Safety reporting and Quality for medical device investigations ### Course Details - The course is approximately 4 hours in duration and is undertaken at the participant's own pace. - Participants must attain a score of 70% in a multiple-choice quiz to receive a certificate of attendance upon completion. - Participants have 42 days to complete the course online and obtain their certificate of attendance from the date of online registration and payment. If the course cannot be completed within this timeframe, participants will need to re-register to maintain access, which will incur a 10 administrative fee. ### Reduced Rates A reduced student rate of 40 is available. To avail of this rate, participants should use the code MEEE7F along with their institutional student email address during enrollment. Please note that student status will be verified following registration using this code, and a current, valid student ID will be requested.