Program Description

Medical Device GCP – Investigator Certificate

Estimated Learning Duration of the Program:
4-8 hours
Program Description:

This program provides investigators and clinical investigation site personnel with a comprehensive introduction to the medical device regulatory environment. It offers an in-depth look at the criteria every investigator should consider before deciding to participate in a medical device clinical investigation.

It covers the following topics:

  • Ethical and legal requirements of medical device clinical investigations
  • How to ensure a successful investigation initiation
  • Effective collaboration with sponsors during investigations
  • Requirements for closing down clinical investigations

The content of this program is based on:

  • ISO 14155: 2020 - Clinical Investigation of Medical Devices for Human Subjects
  • The Declaration of Helsinki
  • 21 CFR 812: Investigational Device Exemption
  • 21 CFR 50: Protection of Human Subjects

Learning Objectives:

Upon successfully completing this program, learners will be able to:

  • Understand the basic medical device regulatory principles for conducting clinical investigations
  • Pay special attention to the risk management profiles of investigational devices, which will enable sound decisions prior to and during clinical investigations and ensure patient safety

Price:€ 210.00

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