Systematic review of usability evaluations in medical devices: Methodological choices, heuristic application, and confounding factors.
PMID: 41483527 ·
Ana Cristina Beitia Kraemer Moraes, Shiren Fathi Yusef Bakri, Caroline Karlinski Scherer, Larissa Oliveira Daneluz Vaz, Jaqueline Yonara da Silva Galhardo, Everton Granemann Souza, Chiara das Dores do Nascimento, Rafael Guerra Lund
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
Official Source
View on PubMed →Data sourced from PubMed / NCBI. For the full text and most current information, always refer to the official record.