Safety-based Product Lifecycle Management of Medical Devices – Electric Wheelchair as an example
碩士 === 國立中央大學 === 工業管理研究所 === 105 === The scope and the development directions of medical devices industry are varied among the countries. Owing to the ageing society and the high-quality healthcare requirements, rapid medical devices industry growth is occurring. The medical devices industry is mos...
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ndltd-TW-105NCU050410082019-05-15T23:39:52Z http://ndltd.ncl.edu.tw/handle/pwzttk Safety-based Product Lifecycle Management of Medical Devices – Electric Wheelchair as an example 以安全為核心的醫療產品生命週期管理 -以電動輪椅為例 Te-En Fang 方德恩 碩士 國立中央大學 工業管理研究所 105 The scope and the development directions of medical devices industry are varied among the countries. Owing to the ageing society and the high-quality healthcare requirements, rapid medical devices industry growth is occurring. The medical devices industry is mostly of hospital consumer products in Western countries. Comparing to Western, the main market in Taiwan is medical consumer products, like Electric Handicapped Scooter (EHS), and electric wheelchair, etc. It can be expected, Taiwan becomes the main supplier in the world. Safety of medical devices directly impacts on the patients. Therefore, the government attaches importance among the medical devices, products control, and verification. For the electric handicapped scooter suppliers in Taiwan, how to ensure the safety during the entire product life cycle becomes a major issue. We describe an information system to support the Product Lifecycle Management (PLM) concept holds the product details of supervising, integrating, and the omnigenous processing. Including research, manufacturing, marketing, customer service, financial, etc. Every step aims to enhance quality and safety assurance. This research illustrates three circumstances. First, we focus electric vehicle wheelchair industry on constructing the PLM system. Furthermore, applying Corrective Action and Preventive Action (CAPA) to inspect the manufacturing procedures. Using Failure Mode and Effect Analysis (FMEA) to find out the potential failure modes and calculate Risk Priority Number (RPN). Using before and after RPN number to know the improving approaches are worth. Finally, strengthen the approaches in CAPA to intensify both the quality and safety of medical devices. It can be applied to any sector, but special attention must be given to each industry particularities in the future. Hsing-Pei Kao Hsing-Pei Kao, 高信培 高信培 2017 學位論文 ; thesis 67 en_US |
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碩士 === 國立中央大學 === 工業管理研究所 === 105 === The scope and the development directions of medical devices industry are varied among the countries. Owing to the ageing society and the high-quality healthcare requirements, rapid medical devices industry growth is occurring. The medical devices industry is mostly of hospital consumer products in Western countries. Comparing to Western, the main market in Taiwan is medical consumer products, like Electric Handicapped Scooter (EHS), and electric wheelchair, etc. It can be expected, Taiwan becomes the main supplier in the world.
Safety of medical devices directly impacts on the patients. Therefore, the government attaches importance among the medical devices, products control, and verification. For the electric handicapped scooter suppliers in Taiwan, how to ensure the safety during the entire product life cycle becomes a major issue. We describe an information system to support the Product Lifecycle Management (PLM) concept holds the product details of supervising, integrating, and the omnigenous processing. Including research, manufacturing, marketing, customer service, financial, etc. Every step aims to enhance quality and safety assurance.
This research illustrates three circumstances. First, we focus electric vehicle wheelchair industry on constructing the PLM system. Furthermore, applying Corrective Action and Preventive Action (CAPA) to inspect the manufacturing procedures. Using Failure Mode and Effect Analysis (FMEA) to find out the potential failure modes and calculate Risk Priority Number (RPN). Using before and after RPN number to know the improving approaches are worth. Finally, strengthen the approaches in CAPA to intensify both the quality and safety of medical devices. It can be applied to any sector, but special attention must be given to each industry particularities in the future.
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Hsing-Pei Kao |
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Hsing-Pei Kao Te-En Fang 方德恩 |
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Te-En Fang 方德恩 |
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Te-En Fang 方德恩 Safety-based Product Lifecycle Management of Medical Devices – Electric Wheelchair as an example |
author_sort |
Te-En Fang |
title |
Safety-based Product Lifecycle Management of Medical Devices – Electric Wheelchair as an example |
title_short |
Safety-based Product Lifecycle Management of Medical Devices – Electric Wheelchair as an example |
title_full |
Safety-based Product Lifecycle Management of Medical Devices – Electric Wheelchair as an example |
title_fullStr |
Safety-based Product Lifecycle Management of Medical Devices – Electric Wheelchair as an example |
title_full_unstemmed |
Safety-based Product Lifecycle Management of Medical Devices – Electric Wheelchair as an example |
title_sort |
safety-based product lifecycle management of medical devices – electric wheelchair as an example |
publishDate |
2017 |
url |
http://ndltd.ncl.edu.tw/handle/pwzttk |
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