Module 14: Design Development and Certification of Medical Devices

Device Knowledge

Question – Where do people use rescue inhalers?

Why is this important?

❑ Where do you test an inhaler in a Human Factors Study?

❑ How do you show the use environment is realistic?

❑ How do you understand the human factors created by the use environment?

The Organisation for Professionals in Regulatory Affairs

Human Factors and Usability Testing during development