Full course description
If you are an Investigator, Research Nurse or have a research role and you are planning to conduct, or are actively engaged in conducting, a clinical investigation of investigational medical device, then this course is for you.
This course is given by the Quality Department of the HRB-Clinical Research Facility – University College Cork
Course Contents:
• 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:
Course is approximately 4 hours duration, undertaken at the participants own pace.
Participants must attain 70% in an MCQ and will get a certificate of attendance on completion.
Participants have 42 days to complete the course online and obtain their certificate of attendance from online registration and payment for same. In the event that the course cannot be completed in this timeframe, participants will need to reregister to maintain access - there will be a €10 administrative fee for same.
Reduced Rates:
Student Rate of €40 available, please use code MEEE7F and your institutuional student email address during enrolment to avail of this. Please note that you will be asked to verify your student status following registration using this code (a current, valid, student ID will be requested).
Contacts and Queries:
Course delivery or content: Lucy Deane Email: lucy.deane@ucc.ie
Payment, registration or certification queries: Centre for CPD Email: cpd@ucc.ie