Course Description

GCP for Investigators: Introduction to Medical Devices

Course Description:

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

Learning Objectives:

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

  • Acquire a working knowledge of the applicable GCP regulatory documents for medical devices
  • Comprehend and define the medical device regulatory environment from an objective perspective
  • Interpret the different essential documents for medical device clinical investigations
  • Contribute to compliance throughout medical device clinical investigation processes

Who Should Enroll:

Principal and co-investigators, study coordinators, site managers, and hospital or ancillary staff involved in the clinical aspects of medical device clinical investigations are all encouraged to enroll in this course.

Prerequisite Knowledge/Requirements:

The following course is required:

  • History of Good Clinical Practice (GCP) (41)

Subject Matter Expert:
Danielle Giroud
Erica Heath

52 min

Related resources:

Case studies:

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Premium Account: € 95.00

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