Current Edition

Clinical Investigation of Medical Devices: Promoting Convergence

The safety, performance and effectiveness of Medical Devices are evaluated by Clinical Investigation before it enters in the market. The integrity of the data is ensured using International standards like ISO 14155:201, Clinical Investigation of Medical Devices for Human Subjects–Good Clinical Practice or ICH E6 Guideline for Good Clinical Practice (GCP) or other GCPs. A clinical investigation design should be made which is appropriate and acceptable by many regulatory This article by Shilpi Khattri, Balamuralidhara V. & T. M. Pramod Kumar of JSS College of Pharmacy, JSS University, Mysore, brings out the differences between ISO GCP and ICH GCP.…pdf