Module 14: Design Development and Certification of Medical Devices

What is the Human Factors and Usability Engineering process?

The human factors engineering process is part of the development of the drug device combination product. It follows a traditional path – Research, Design, Develop, Verify and Validate.

Research

Design

Develop

Verify

Validate

The key elements are:

▪

User research.

▪ Risk Management of use-based risks.

Hazardous Use

Abnormal Use

Typical Use

Mis-Use

▪ Development and the design of User Interfaces. ▪ Verification and Validation of the drug device combination product with intended users, in the intended use environments.

The Organisation for Professionals in Regulatory Affairs

Human Factors and Usability Testing during development