FDA is raising awareness among health care providers and facility staff that cybersecurity vulnerabilities in certain GE Healthcare Clinical Information Central Stations and Telemetry Servers may introduce risks to patients while being monitored.  Per the FDA notice: “A security firm has identified several vulnerabilities in certain GE Healthcare Clinical Information Center workstations and Telemetry Servers,...Read More

Going way back to the late 1990’s, FDA had an expectation that safe and effective software would require a well thought out development lifecycle that includes many activities designed to ensure the correctness and robustness of all software that was part of the medical device.  A key guidance document was created known as the General...Read More