Program Description

Basics Clinical Evaluation - Regulatory Professionals Certificate

Estimated Learning Duration of the Program:
3-6 months
Program Description:

This program provides insight into the clinical evaluation and investigation processes for medical devices worldwide.

Understanding the basic principles of Good Clinical Practice (GCP) as per ISO 14155, 21 US CFR 812, and other GCP rules and regulations is essential for medical devices in the pre- or post-market clinical investigation process. 

Learning Objectives:

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

  • Apply GCP principles to clinical evaluations and investigations
  • Understand the in-depth mechanisms of safety reporting during clinical investigations in the EU and US

Price:€ 534.00

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