Standards

Carilion Institutional Review Board (IRB)

The IRB reviews research protocols involving humans in order to protect their rights and welfare when they participate in research. The board also ensures that research complies with federal, state, and local regulations and can issue Investigational Device Exemption for human testing if the product is deemed to have no significant risk.

CE Certification

The CE certification signifies that a product meets high safety, health, and environmental protection requirements.

Federal Communications Commission Declaration of Conformity (FCC)

The FCC certifies that the radio frequency of electronic products manufactured or sold in the United States does not have the potential to cause harmful interference to radio services.

FDA Title 21

Title 21 is a set of standards that all medical devices must follow. It pertains to all processes and equipment involved in clinical production and trials.

ISO 14155

The standard ISO 14155 is Clinical Investigation of Medical Devices for Human Subjects - Good Clinical Practice

ISO 13485

The standard ISO 13485 is Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes