Program Description

EU Medical Device regulatory Affairs Certificate

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

This program outlines all information concerning medical device regulations in Europe. 

It covers the following topics:

  • Medical device directive requirements
  • Additional guidance documents
  • In-depth review of clinical data requirements
  • Specific components regulatory professionals must pay attention to
  • Labeling requirements

Please note that the standards on quality systems (ISO 13485), risk management (ISO 14971), and biological evaluations (ISO 10993) are covered in separate courses.

Learning Objectives:

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

  • Establish the regulatory pathway for a specific medical device under EU medical device directives
  • Ensure conformity with essential requirements for all aspects of a given medical device
  • Define the main requirements of pre-clinical validation
  • Determine what clinical data is needed to reach the CE-mark, including post-market clinical follow-up requirements

Price:€ 1,179.00

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