Cause Effect Essays. 1  Examine why something has happened or exists. 2  Speculate about what caused the situation. 3  Examine the results of an event, choice, or situation. 4  Trace the start of a situation to a discussion of its results.
Since 1990, the Food and Drug Administration (FDA) has required that medical device manufacturers that want to market certain categories of medical devices in the USA follow Design Control requirements (21 CFR 820.30). Clear documentation of the entire process in a design history file or DHF.
Design input requirements should be unambiguous. 1  That is, each requirement should be able to be verified by an objective method of analysis, inspection, or testing. For example, it is insufficient to state that a catheter must be able to withstand repeated flexing.