Program Description

Medical Device GCP for Investigators

Estimated Learning Duration of the Program:
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: 2011: 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

Program Pricing

Prices have not been set for this program.