Program Description

EU IVD regulatory Affairs Certificate

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

This program contains all information concerning IVD device regulations in Europe, as well as a detailed overview of the upcoming draft regulation.

It covers the following topics:

  • Medical device directive requirements
  • Additional guidance documents
  • Quality systems standards (ISO 13485)
  • Risk management standards (ISO 14971)

Learning Objectives:

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

  • Define the regulatory pathway for IVD devices under EU medical device directives
  • Ensure conformity with essential requirements for all aspects of a given IVD device

Program Pricing

Price1 onlyAs of 5As of 10As of 20As of 50
Price / person €473.00426.00378.00331.00Contact us
Price / person $558.14502.68446.04390.58Contact us