International – (CFR) 21 part 820.30 : Design verification and validation versus human factors validation

In the complex world of medical device regulation, it can be difficult to keep things straight when it comes to product development. Different methods are needed to demonstrate that your production-ready medical device is safe and effective and meets its intended users’ needs. These methods generally fall under the umbrella of design verification and validation (V&V). However, the terms “design verification” and “design validation” are so often lumped together that it can be difficult to distinguish between the two activities. To add to the confusion, US FDA defines a separate validation test, referred to as human factors validation, that seemingly exists in a category of its own.

Definitions and perspectives

This post seeks to clarify the differences between each phase of the V&V process and to provide an example of how design verification, design validation, and human factors validation would be used to demonstrate that a specific user need is met. Before we dive in, it’s important to point out that different medical device manufacturers might think differently about what constitutes design verification, design validation, and human factors validation. This post represents just one perspective, while other perspectives still may be completely valid and meet the needs of regulatory requirements…