This course focuses on the regulation of medical devices and is self-paced.
It is made up of three lessons:
Lesson 1: Introduction to Medical Devices
Lesson 2: International Standards for Medical Devices
Lesson 3: Quality Assurance for Medical Devices
Lessons may be studied in the order they are presented, or learners may use the menu feature to skip lessons they are already familiar with or have no interest in.
Depending on learners’ previous knowledge and needs, study time for the course may vary from 30 to 60 minutes.
Lessons are interactive and engaging to help course takers learn the content and to make learning fun!

Subject area:
Regulatory System Strengthening

Objectives (If applicable):
• Describe what medical devices are, identify their characteristics, and explain how they are classified. (Lesson 1)
• Explain the importance of international standards and industry best practices to ensure safety and medical device quality (Lesson 2)
• Define quality assurance and activities required for maintenance of medical device safety and performance. (Lesson 3)

Target Audience (If applicable):
This course is designed for anyone who works in medical products production and quality assurance, including manufacturers and regulatory authorities.