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

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