Medical-device usability testing and validation are critical tasks leading up to a medical device’s debut on the market. “Usability” looks at how the user interacts with your device and forms a key component of overall risk management and safety.

If there’s any “spoiler alert” to this article, it’s that human factors, including usability and validation, should not be put off to the last minute. The ultimate goal of early planning for usability testing and validation of your medical device is to ensure you’re building a safe and effective product for the end user.

Early considerations should evolve into formal procedures for usability testing and validation activities that live within your quality system. This will prevent you from needing to scramble last minute or work retroactively once it’s time for your device submission.

This article provides an introductory look at usability testing and validation, and how to build these key components into your quality system.

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