IRB Requirements for Medical Device Usability Testing in Japan: Key Triggers, Timelines, and Documentation
Understand IRB requirements for medical device usability testing in Japan, including risk factors, review timelines, and key documentation considerations.
HFES Panel Report: Practical Differences in Medical Device HFE Across Asia
✶Article Summary In HFE (Human Factors Engineering) evaluations across Asia, outcomes are influenced not only by regulatory requirements but also by execution conditions such as healthcare systems and recruitment realities. Cultural factors also shape how users provide feedback and interpret errors, meaning that data collection methods (including moderation) must be carefully designed. Intro I recently had […]
Recruiting Participants for Medical Device Usability Evaluations in Japan: A Practical Guide for PMDA Submissions
How to recruit users for PMDA submission in Japan? Get a practical guide on sample size justification, finding HCPs, and navigating local recruitment hurdles.