Module 14: Design Development and Certification of Medical Devices

Why is Human Factors and Usability Engineering important?

❑ To ensure the intended users can use the product.

❑ To ensure that the intended users are safe when using the product.

❑ To ensure that the intended user receives the clinical performance they expect when using the device.

❑ To ensure the intended user has everything required to be compliant to the medical regime the prescriber needs.

❑ To ensure that the user has the device when they need to use it.

❑ To ensure that the user can manage a medical regime, especially if they are a patient.

❑ To ensure there is a clinical benefit to the patient in using the device.

❑ To ensure that the intended user has a positive user experience.

The Organisation for Professionals in Regulatory Affairs

Human Factors and Usability Testing during development