Developing Medical Device Software – Blog

“Developing Medical Device Software,” new Med Device Online article series by Sterling Medical Devices While nowadays Safety Assurance Cases are mostly limited to infusion pumps, medical device software companies should consider preparing for a potential expansion of this case practice … Continued

What is ISO 14971?

ISO 14971 is the application of a risk management process for medical devices. It outlines the process you are going to follow for risk analysis. It entails going through risk analysis, a risk evaluation, risk mitigations, and a residual risk … Continued