Program Description

Medical Device Design and Validation Processes Certificate

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

This program examines the elements of a well-defined and controlled design and validation processes.

It covers the following topics:

  • Expert insight into the sources of design process requirements
  • State-of-the-art specification requirements
  • Design output, verification, validation, and transfer
  • Design change control process and its interfaces throughout the design process

Further courses explore the different modalities for medical device testing requirements.

Learning Objectives:

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

  • Assess whether the implemented design process meets regulatory requirements
  • Plan the different phases involved in the medical device design and validation processes
  • Define the necessary validation steps needed to ensure conformity to EU and US regulatory requirements

Price:€ 1,078.00

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