1st PMDA Medical Devices Training Seminar(DAY 3)

Topic 1: Today's Lectures

There were two lectures in the morning, clinical trials for medical devices, and GLP/GCP inspection for medical devices. In-depth discussions followed, like some exceptional cases against general concepts, reflecting the complexity of actual implementations. In the afternoon, presentations on safety measures for medical devices, and QMS for medical devices were given. Like those discussions in the morning, there were very extensive and in-depth questions from the participants, as there are many critical issues involved in these areas.

　

　

 

Comments from participants

ASAHIKAWA, Hokkaido