Program Description

Medical Device GCP – Germany: Investigator Certificate

Estimated Learning Duration of the Program:
1-2 days
Program Description:

This program provides investigators and clinical investigation site personnel with a comprehensive introduction to the medical device regulatory environment in Germany. 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 for medical device clinical investigations in Germany
  • How to ensure a successful investigation initiation
  • Effective collaboration with sponsors during investigations
  • Requirements for closing down clinical investigations
  • An additional course specifically for German investigators and site personnel

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 Exemption21 CFR 50: Protection of Human Subjects
  • Medical Devices Act (MPG)
  • Other related German ordinances

Learning Objectives:

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

  • Apply German and international regulations for conducting medical device clinical investigations
  • Pay special attention to the risk management profile of investigational devices, which will enable sound decisions prior to and during clinical investigations and ensure patient safety

Program Pricing

Price1 onlyAs of 5As of 10As of 20As of 50
Price / person €298.00268.00238.00209.00Contact us
Price / person $339.72305.52271.32238.26Contact us