Good Clinical Practice in Medical Device Research


Please note

All in person course dates are provisional and subject to numbers. You will be contacted by the course coordinator once a date is confirmed. This course is also now available to complete online – you can apply at any time and complete the course material in your own time and at your own pace.

Offered in partnership with the RCSI School of Postgraduate Studies, this one-day course (six hours) is aimed at investigators, project managers, research nurses and other research team members involved in the conduct of medical device research at a clinical research site. It is also relevant to sponsors and device manufacturers involved in organising and initiating clinical investigations.

The course is based on the requirements of the Medical Device Regulations and ISO 14155, and includes the following content:

  • Principles of good clinical practice in medical device research
  • Medical devices (What is a medical device?; types and classification; medical device legislation; clinical investigations)
  • Good clinical practice in device trials (ethical issues; planning and conducting a clinical investigation)
  • Safety reporting in device research; monitoring and audit

Venue: Tutorial Room 1, RCSI Education and Research Centre, Beaumont Hospital
Date: Wednesday, 27 September 2023



Introduction to Medical Device Research

Principles of Good Clinical Practice in Device Research

Medical Devices

  • What they are
  • Types and Classification
  • Workshop 1
 11:00  Break

Clinical Investigations

Medical Device legislation

Good Clinical Practice in Medical Device Research

  • Ethical Considerations
  • Workshop 2
  • Planning a Clinical Investigation
  • Conduct of a Clinical Investigation

Responsibilities of the Principal Investigator

Quality Management and Safety Reporting

  • Safety Reporting in Device Research
  • Workshop 3
  • Monitoring and Audit
 16:00  Conclusion