Pre-market Studies

Pre-market Clinical Investigation is a clinical investigation carried out before market approval of the investigational device.

The Pre-market Clinical Investigation is designed and planned to verify the medical device safety and performance objectives and clinical claims identified in the Clinical Evaluation process.

Qmed can help you:

• Identify the safety and performance objectives for your device
• Set up a proper study design a first in human, feasibility or pivotal trial
• Determine the right level of monitoring for the specific study design including use of risk based monitoring