GCP for Investigators: Introduction to Medical Devices

This course provides basic and background information on medical device Good Clinical Practice (GCP).

It covers the following topics:

• Overview of essential elements
• Review of the regulatory environment of medical devices in the EU and US
• How the Declaration of Helsinki applies to the medical device field
• Relevant GCP regulatory documents
• Major differences between ICH E6 GCP and medical device GCP as outlined in ISO 14155
• Necessary manufacturing steps for conducting clinical investigations
• Brief review of the elements of medical device study designs

The content of this course is based on:

• ISO 14155: 2011: Clinical Investigation of Medical Devices for Human Subjects
• The Declaration of Helsinki
• 21 CRF 812: Investigational Device Exemption
• 21 CRF 50: Protection of Human Subjects