The U.S. Food and Drug Administration, Center for Devices and Radiological Health announced today that they had qualified a new tool for the evaluation of lethal arrhythmia alarm detection algorithms used in hospital-based patient monitoring systems (UCSF LAD MDDT), through the Medical Device Development Tools (MDDT) program. The University of California San Francisco (UCSF) Lethal...Read More

Brian Pate has created this job aid to assist with explaining the separation of design input from the design process.  The diagram illustrates the "flow down" process of high level, intended use functionality traces downward to more detailed requirements and specifications.  Where do we draw the line with design input?  What should be the focus...Read More

For anyone involved in software development, the importance of software requirements cannot be minimized. Software requirements provide the definition and explanation of “what the software should do” and “how the software should behave.” The software engineers and developers use the requirements as input to the software design and coding process. The test developers also use...Read More