ISO 14155 Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice

Online, Instructor-Led Course

Online, Instructor-Led Course

Course Description 

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.

Course Benefits

ISO 14155:2020 - Clinical investigation of medical devices for human subjects – Good Clinical Practice is the latest edition of the ISO 14155 standard for the design, conduct, recording, and reporting of medical device clinical investigations. The training provides standard guidance to medical device manufacturers and clinical research professionals for how to implement Good Clinical Practice (GCP) for pre- and post-market clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.

Target Group

The training is designed to be beneficial to persons involved in clinical investigation supply chain, such as the sponsor, Investigator (Clinical Investigation Sites, site study team members), Clinical Investigation service providers (Clinical Research Organisations, Clinical Research Centers, Statistician, Medical writer, safety/performance committees, software providers), Research support team (study managers, study coordinators), etc.

Learning Objectives

  • 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

Course Agenda

Please see the draft agenda, more descriptive and detailed agenda will be provided.

Time Topic
9:00 - 9:30 Welcome and Introduction
9:30 - 10:00 Good Clinical Practices (GCP) Basics
10:00 - 11:00 ISO 14155:2020 Section 1, 2, 3, and 4
11:00 - 12:00 ISO 14155:2020 Section 5 and 7
12:00 - 1:00 Break
1:00 - 2:00 ISO14155:2020 Section 6
2:00 - 3:00 ISO 14155:2020 Section 8
3:00 - 4:00 ISO 14155:2020 Section 9
4:00 - 4:30 Summary and Closing
4:30 - 5:00 Test and End of Training

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