ISO 14155 Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice
Participants in this course will:
- Learn the basis of ISO 14155
- Requirements for planning and conduct of clinical investigation
- ISO 14155 in the frame of MDR
- Differentiation of the roles and responsibilities of sponsor and the principal investigator
Training Agenda
9:00 -9:30 Welcome and Introduction
9:30-10:00 GCP Basics
10:00-10:30 ISO 14155:2020 Section 1,2,3,4
10:30 – 11:00 ISO14155:2020 Section 5,7
12:00-13:00 Break
13:00- 14:00 ISO14155:2020 Section 6
14:00-15:00 ISO 14155:2020 Section 8
15:00-16:00 ISO 14155:2020 Section 9
16:00-16:30 Summary and closing
16:30-17:00 Test and end of training
The ISO 14155 standard provides the requirements for clinical investigations intended to:
- Protect the rights, safety, and well-being of human subjects,
- Ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
- Define the responsibilities of the sponsor and principal investigator, and
- Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
The ISO 14155 standard defines the state-of-the-art approach for the clinical development strategy for medical devices with the purpose to gather, record, and analyze relevant data on the quality, performance, and safety of a device throughout its entire life cycle covering pre-, and post-market phases. The principals set forth in the standard are intended to be followed for pre-market and for post-market clinical investigations, as far as relevant. The clinical development stages outlined include pilot, pivotal and post-market stages, covering interventional clinical investigations such as first in human, feasibility, and pivotal clinical investigations, but also observational and non-interventional clinical investigations.