| Summary: | 碩士 === 國立成功大學 === 工業設計學系碩博士班 === 101 === The rate of research and development is the essence of the enterprises nowadays. For the Small and Medium-Sized Enterprises (SMEs), looking after both the safety and quality in pursuing the rate is the vital condition to success. In view of this, there will be a probe into how the SMEs utilize Failure Mode and Effects Analysis (FMEA) and Concurrent Engineering (CE) to enhance the safety and quality of the products.
In this research, the product planning sheet of design examination procedure from Medical Device Quality Management System (ISO-13485), FMEA from Risk Management Standard for Medical Devices (ISO-14971), with the Design Code, Objectives Tree, Morphological Analysis from CE, and Analytic Hierarchy Process (AHP) will be employed as the evaluation methods to get the optimizing design. During the process, I will store all the product sheets in the cloud system, set the knowledge management standards, and apply this procedure to SMEs to shorten the procedure of research and development, share the knowledge and exclude the causes of the failure during the developments of assistive devices. The medical assistive device, hanger, will be adopted in the thesis as the design verification.
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