Systematic review of usability evaluations in medical devices: Methodological choices, heuristic application, and confounding factors.

Abstract

Usability evaluation is a regulatory and safety requirement in medical device development, as defined by the International Electrotechnical Commission (IEC) IEC 62366-1/2 and the United States Food and Drug Administration FDA guidance. These frameworks establish processes for identifying and mitigating risks associated with device use under normal conditions, but they do not guarantee methodological consistency or scientific reproducibility. Consequently, usability testing is often implemented a