Recruiting Participants for Medical Device Usability Evaluations in Japan: A Practical Guide for PMDA Submissions
As UX researchers specializing in medical devices, we often receive questions from manufacturers outside Japan who are looking to enter the Japanese market. One of the most common is: “How should we recruit participants for a usability evaluation in Japan?” While you might be familiar with established practices for usability testing in the U.S. and Europe, […]
Sample Size and Test Environment Requirements for PMDA HFE Submission: A Practical Guide for Validation Studies in Japan
PMDA’s overall HFE mindset is aligned with international regulatory frameworks, but expectations in certain areas can differ. In particular, PMDA takes a distinct approach to topics such as sample size determination and test environment considerations. This guide outlines key points based on the implementation of JIS T 62366-1:2022 and current PMDA expectations. Sample Size PMDA does not […]