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Read the Syncroness white papers that will be presented at this year's INCOSE International Symposium
Abstract. Whether it is a small company hoping to start using systems engineering with a Model Based Systems Engineering (MBSE) approach, or a larger, established company interested in converting existing document-based practices to MBSE, the challenges can be daunting. These can include unfamiliarity with the MBSE tool, complex default schemas, and understanding what is worth tracking in MBSE (or not). This paper will address the practical aspects for building and using a simplified MBSE schema. The schema details a selection of diagrams and items to be used for each phase of the product development process. The practical aspects for what information to include, how to trace items to each other, and what to include in each output document are described and demonstrated with examples.
Abstract. Statistical techniques are required for medical devices and can be used to make verification more meaningful in any industry. Sometimes, a company needs to predict how their total population of devices will perform. Other times, teams simply need stronger justifications than ‘that’s how many we had’ or ‘we always test 5’ for test plans and sample sizes. However, there are an overwhelming number of statistical methods and references available. We have identified three tests that can be used to verify many types of device requirements: pass/fail (binomial), tests on the population (tolerance interval), and tests on the mean (t-tests). This paper provides the information needed to choose a test, pick the right statistical claim and related parameters, determine the sample size needed to pass, and write acceptance criteria that makes it easy to determine a pass or fail.