The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR Part 820. The device labeling contains instructions for use and any necessary cautions and warnings for safe and effective use of the device. Risk management is ensured via a risk analysis, and risk control(s) have been implemented to mitigate identified potential hazards (conforming with “ISO 14971:2007 Medical devices –Application of risk management to medical devices”). Testing for verification and validation of the device supports that all software specifications have met the acceptance criteria.