研發速度為企業生存之道，如何能在追求速度中同時兼顧安全及品質，這是所有中小企業所急需之成功條件，有鑒於此，論文中將探討中小企業運用失效模式分析及同步工程提高符合安全性及品質效率之產品。
本研究將運用醫療器材品質管理標準(ISO -13485)中的設計審查程序之新產品企劃書和醫療器材風險管理評估標準(ISO -14971)中之失效模式分析( FMEA )，加上同步工程( CE )方法之設計規範、目標樹 ( Objectives Tree)、形態學圖表法 ( Morphological Analysis )，最後以層級分析法( Analytic Hierarchy Process, AHP )作為評價方法，並得到最佳化設計，過程中將所有產出之表格放置在雲端中，建立知識管理標準，並運用此套流程至中小企業中，以縮短研發流程，知識共享互用，排除在開發中輔具產品失效之原因。本論文以醫療輔具-病人吊架做為設計驗證。

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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