These studies are conducted to gather preliminary clinical data to assess the safety and efficacy of the medical device.
The medical device has already been technically verified and pre-clinically tested. Some devices are tested using animal models 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 either pre-final or final and has not yet been thoroughly tested on humans. There are risks that the human body may not interact with the device as expected, and the main goal is to confirm the device’s safety. The study design should be created with careful consideration of the potential risks associated with the nature of the device.
The study should be planned and conducted in strict accordance with GCP and local legislation. All ethical and regulatory aspects must be properly managed, including patient insurance, Central Regulatory Approval, Ethics Committee approval, and other mandatory activities, which should be supervised by the manufacturer. Regulatory, documentation, and procedural activities in GCP-compliant studies are complex. This is why specialized clinical research organizations (CROs) are often subcontracted to manage clinical studies properly.
