Your PMDA Submission: An Integrated Approach to Usability (62366-1) and Risk (14971)
Understand key usability evaluation requirements for PMDA submissions, including how JIS T 62366-1 and JIS T 14971 work together in medical device risk management.
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.