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

Instructor-led Training1 DayBeginnerVirtual Classroom

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.

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from$ 1,000.00

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Book training ISO 14155 Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice
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From 05/20/24
$ 1,000.00 excl. TAX

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Price (excl. TAX):
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