About otssoftware.org

As the usage of general-purpose computer hardware grows more ubiquitous, off-the-shelf (OTS) software is increasingly being evaluated for implementation into medical devices. The usage of OTS Software in a medical device allows the manufacturer to focus on the application software required to execute device-specific operations. However, OTS Software designed for general-purpose computing may not be acceptable for a particular specialized usage in a medical device. The medical device maker who uses OTS Software usually relinquishes software life cycle management, but is still responsible for the medical device's continuous safe and effective operation.