These studies are conducted to gather clinical data preliminarily checking the safety and efficacy of the medical device.
The medical device has been already checked and verified technically and pre-clinically. Some devices are tested using animal models in order to verify safety and toxicity. The feasibility study is considered a clinical study since patient data are collected.
At this stage of development, the device is considered a pre-final or final and has not yet been thoroughly tested on humans. There are some risks that the human body will not interact with this device appropriately and the main goal is to confirm the safety of the device. Study design should be created considering possible risks that are linked with the nature of the device.
Study should be planned and conducted in strict accordance with GCP and local legislation. All ethical and regulatory aspects should be properly managed. Patients’ insurance, Central Regulatory Approval, Ethics Committee approval, and other obligatory activities should be supervised by the manufacturer. Regulatory, documental, and procedural activities in GCP-compliant studies are complex. That is why specialized clinical research organizations (CROs) are usually subcontracted to manage clinical studies in a proper way.
