The Importance of Usability Testing of Medical Devices

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.