ISO 14155:2026: What Medical Device Teams Need to Know
In March 2026, ISO published the fourth edition of ISO 14155, replacing the third edition (ISO 14155:2020, now formally withdrawn). ISO 14155 is the internationally recognized Good Clinical Practice (GCP) standard for designing, conducting, recording, and reporting clinical investigations of medical devices in human subjects, and it underpins clinical investigation expectations referenced by regulators, notified […]
