Medical Devices Development map
Medical Devices Development map

DEVICES introduction
The development and manufacture of medical devices under a controlled environment is essential to assure that the device will be safe and effective in accordance with its intended use. Medical devices are regulated based upon a classification system that evaluates the complexity and the risk posed by the product and the level of control needed to adequately assure safety.

Basic Research

Clinical Trials for Medical Devices

FDA Filing/Approval

Preclinical Development of Devices

Quality Systems Regulation


NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.