Program Description

Medical Device Quality Assurance Certificate

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

This program covers basic quality assurance principles and examines how quality assurance systems form the backbone of the medical device development, production, validation, and market processes.

It covers the following topics:

  • ISO 13485
  • Review of ISO 14971
  • US–QSR system
  • How to successfully pass an inspection by both notified bodies and the FDA
  • Importance of risk management
  • Practical guidance on how to apply risk management to all processes involved in bringing medical devices to market

Learning Objectives:

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

  • Apply EU and US quality assurance principles
  • Recognize that the EU principles are used in most countries throughout the world

Program Pricing

Price1 onlyAs of 5As of 10As of 20As of 50
Price / person €865.00779.00692.00606.00Contact us
Price / person $1020.70919.22816.56715.08Contact us