Open Access Graduate Research Paper
In the medical device industry, design controls are an interrelated set of practices and procedures that are incorporated into the design and development process and must be followed in order to develop a product and commercialize it under regulated standards and regulations. Verification tests are an important step in the design controls. As these various systems and subsystems are designed, design verification testing methods are used to make sure that each design conforms to its own specifications. However, due to resource and budget availability, not every single presentation of the product family is tested in the verification phase. A corner case (or pathological case) involves a problem study or situation where products are tested in extreme environmental variables or operational conditions in order to verify the worst case of a product family and establish the confidence for the rest. In this paper, a test method to evaluate the syringe break loose and expulsion force is addressed, in which the corner case conditions for a syringe assembly were identified, the syringe assembly filled with medication solutions was tested, and the collected data were used to compare and leverage existing similar products. Minitab 17.0 was used to support the study and analysis.
Year of Submission
Master of Science
Department of Technology
1 PDF file (26 pages)
©2016 Xin Zhang
Zhang, Xin, "Corner Case Strategy and Its Application in Medical Device Design Verification: A Case Study with Syringe Break Loose and Expulsion Force Testing" (2016). Graduate Research Papers. 3907.