Compared with character-based programming, however, a GUI adds significant complexity. On the other hand, how the instrument delivers fluid or heats a sample is usually not integral to what the instrument does. Safety Requirements . FDA's quality system regulation requires manufacturers to follow an exact and explicit development process, including risk analysis. During the design stage, manufacturers must investigate how a device might fail, what the risks are, and how hazards can be mitigated.
Risk analysis is crucial.
For example, a major IVD system manufacturer didn't pay enough attention to hazard mitigation in the relationship between software and electromechanical components in a blood testing instrument. When it became evident that some samples could be confused with others while inside the device, significant software and some of the electromechanics had to be redone, costing several years of delay. The company eventually realized that critical system issues could have been resolved with teamwork. Safety concerns must be planned for early in the product development process. Product development documentation consists of three equally important sets of requirements.