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The Importance of Usability Testing of Medical Devices

Usability testing can expose a wide range of design flaws that might not have been obvious to the product development team. Here is a sample of interaction problems that we have observed in the course of testing medical products and attributed to user interface design flaws.

Doctor standing over patient in a hospital

Usability testing is critical for establishing that a medical device or IVD can be used safely and effectively, and it can also capture feelings from potential users about how convenient and appealing the product is to operate. This white paper explains why usability testing is important, what regulators worldwide are looking for, and what the differences are between formative and human factors validation (a.k.a. summative) tests. It also provides a step-by-step guide to conducting usability testing, from the planning phase to data analysis and reporting.

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Conduct medical device usability testing using our step-by-step guide

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