title: Engineering in software testing: statistical testing based on a usage model applied to medical device development.
abstract: When a population is too large for exhaustive study, as is the case for all possible uses of a software system, a statistically correct sample must be drawn as a basis for inferences about the population. A Markov chain usage model is an engineering formalism that represents the population of possible uses for which a product is to be tested. In statistical testing of software based on a Markov chain usage model, the rich body of analytical results available for Markov chains provides numerous insights that can be used in both product development and test planing. A usage model is based on specifications rather than code, so insights that result from model building can inform product decisions in the early stages of a project when the opportunity to prevent problems is the greatest. Statistical testing based on a usage model provides a sound scientific basis for quantifying the reliability of software.
authors.affiliation: Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20857, USA. pxj@cdrh.fda.gov
authors.forename: P L
authors.initials: PL
authors.lastname: Jones
authors.forename: W T
authors.initials: WT
authors.lastname: Swain
authors.forename: C J
authors.initials: CJ
authors.lastname: Trammell
mesh_terms: D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards*; D008390:Markov Chains; D015233:Models, Statistical; D011786:Quality Control; D011859:Radiography / Q000295:instrumentation; D015203:Reproducibility of Results; D012984:Software / Q000592:standards*; D012986:Software Validation; D014481:United States