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.
The objective of Design Controls, in this context, is to require that manufacturers follow a methodologically-sound process to develop a medical device, with the intent of improving the probability that the device will reach an acceptable level of efficacy and safety. 21 CFR 820.30 on the FDA website [1]