Medical device manufacturers constantly strive to develop safe, secure, intelligent, and connected products, balancing the stringent regulatory requirements of worldwide agencies such as the U.S. Food and Drug Administration (FDA) with the aggressive time-to-market deadlines and cost pressures that govern the industry. After deployment, these devices stay in the market for more than a decade and need periodic software and hardware upgrades based on changing customer needs.
Because patients' lives may be in the balance, software used in medical devices must meet stringent regulatory guidelines to ensure that it will perform as promised. Trying to cobble together software solutions without commercial support puts the burdens of testing, validation, documentation, and compliance on the device manufacturers and their developers.
To meet medical industry safety standards and regulations, device manufacturers must find a way to tackle the increased security risks of the connected era. Wind River provides customers using Wind River Platform for Medical Devices with a Qualification Summary, in accordance with FDA quality system regulation 21CFR820.50 Purchasing Controls requiring manufacturers to evaluate suppliers for their ability to meet requirements, including quality requirements. The summary fits right in with your risk-based supplier qualification. Other tools, such as Wind River Test Management, provide customers with the ability to identify high-risk segments in production code and reduces the risk of critical bugs slipping through in untested code and showing up in medical devices in the home, hospital, or doctor's office.