Program Description

Basics in Regulatory Affairs Certificate

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

This program was developed for regulatory professionals new to the medical device industry who want a quick grasp of the basic medical device regulatory principles.

While many regulatory systems exist throughout the world, the Global Harmonization Task Force (GHTF, now IMDRF) created the international standard. Their comprehensive series of guidance documents outlines principles for further skill development for any regulatory system worldwide.

This program covers the following topics:

  • The medical device lifecycle
  • Steps to ensure beneficial market feedback
  • Relevant pre-clinical and clinical evaluations
  • Risk management systems

Learning Objectives:

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

  • Apply the basic regulatory affairs principles to country-specific regulations
  • Acquire the skills needed to function in a regulated medical device environment
  • Understand the following concepts:
    • Risk management
    • Good documentation practices
    • Proper use of technical standards
    • Pre-clinical and clinical validation

Program Pricing

Price1 onlyAs of 5As of 10As of 20As of 50
Price / person €875.00788.00700.00613.00Contact us
Price / person $980.00882.56784.00686.56Contact us