Testing

This chapter provides an overview of the testing process, assuming only a general technical background, with references to provide greater depth. Testing is a vital and integral element in the successful design and release of a medical device. The best way to analyze the data is to look at a picture of it–plot the data. If possible, include error bars to indicate the uncertainty in the measurement device, to put the plotted values into context. The value that a testing program adds to a manufacturer’s business practice lies in the reexamination of the design and of the assumptions concerning its capabilities. The process of testing a component or product can yield a bounty of information. A hypothesis test compares the numeric outcome of the test against an assertion, termed the “null hypothesis”. Most introductory statistics texts, such as Strait, describe a variety of tests in which the reference population is assumed to be normally distributed.