博碩士論文 106456033 詳細資訊




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姓名 陳岳璣(Yuehchi York Chen)  查詢紙本館藏   畢業系所 工業管理研究所在職專班
論文名稱 醫療器材業設計驗證與確效流程管理
(Design Verification and Validation Process Management in Medical Device Industry)
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摘要(中) 醫療器械的開發是一個複雜且受到高度監管的過程,需要嚴格遵守各種行業標準和法規。此過程中的主要挑戰之一是確保設備安全、有效並滿足其預期用戶的需求。為了應對這一挑戰,本文提出了一個框架,通過使用設計驗證和確效來改進醫療設備開發過程,並由整合資訊系統架構 (ARIS) 和有效的研發管理提供支援。

擬議的框架概述了設計、開發和驗證醫療器械的綜合方法。該框架結合了來自不同行業的一系列最佳實踐,包括設計思維、以用戶為中心的設計和敏捷開發。該框架還利用了 ARIS這一強大的複雜系統建模和分析工具,以確保所有利益相關者對開發過程有清晰的了解,並可以輕鬆識別需要改進的領域。

此外,有效的研發管理在確保開發過程順利進行以及所有利益相關者在項目目標上保持一致方面發揮著關鍵作用。本論文概述了有效研發管理的主要原則,包括項目規劃、風險管理和團隊溝通,並論證瞭如何將這些原則應用於醫療器械開發。

最後,本文提出了一個案例 研究,說明了所提出的框架在醫療器械開發中的應用。案例研究展示瞭如何使用該框架來確保器械滿足其預期用戶的需求並符合所有相關法規和標準。

括以蓋之,本文提供了一個全面的框架,通過有效的設計驗證和確效,在 ARIS 和有效的研發管理的支援下,改進醫療器械開發過程。擬議的框架有可能提高醫療設備開發過程的效率和有效性,並最終提高患者的醫療品質。
摘要(英) The development of medical devices is a complex and highly regulated process that requires strict adherence to various industry standards and regulations. One of the key challenges in this process is ensuring that the devices are safe, effective, and meet the needs of their intended users. To address this challenge, this thesis proposes a framework for improving the medical device development process through the use of design verification and validation, supported by the Architecture of Integrated Information System (ARIS) and effective R&D management.

The proposed framework outlines a comprehensive approach to designing, developing, and validating medical devices. The framework incorporates a range of best practices from various industries, including design thinking, user-centered design, and agile development. The framework also leverages ARIS, a powerful tool for modeling and analyzing complex systems, to ensure that all stakeholders have a clear understanding of the development process and can easily identify areas for improvement.

Additionally, effective R&D management plays a critical role in ensuring that the development process runs smoothly and that all stakeholders are aligned on the project goals and objectives. This thesis outlines the key principles of effective R&D management, including project planning, risk management, and team communication, and demonstrates how these principles can be applied in the context of medical device development.

Finally, this thesis presents a case study that illustrates the application of the proposed framework in the development of a medical device. The case study demonstrates how the framework can be used to ensure that the device meets the needs of its intended users and is compliant with all relevant regulations and standards.

Overall, this thesis provides a comprehensive framework for improving the medical device development process through effective design verification and validation, supported by ARIS and effective R&D management. The proposed framework has the potential to improve the efficiency and effectiveness of the medical device development process and ultimately improve the quality of care for patients.
關鍵字(中) ★ 整合資訊系統架構
★ 企業流程管理
★ 醫療器材產業
★ 研發管理
★ 設計驗證
★ 設計確效
關鍵字(英) ★ Architecture of Integrated Information System, ARIS
★ Business Process Management, BPM
★ Medical Device Industry
★ R&D Management (Research and Development Management)
★ Design Verification
★ Design Validation
論文目次 摘要 .................................................. i
Abstract ............................................. ii
誌謝 ................................................. iv
List of Figure ....................................... vi
List of Table ....................................... vii
Chapter 1 Introduction ................................ 1
1-1 Research Background and Motivation................. 1
1-2 Research Objective and Methodology ................ 3
1-3 Research Range .................................... 3
1-4 Research Framework and Process .................... 3
Chapter 2 Literature Review ........................... 5
2.1 Interdiction of Medical Device Manufacturing ...... 5
2.2 Definition of Medical Device ...................... 6
2.3 Regulations of Medical Device .................... 11
2.3 Design Verification and Validation (DV&V)......... 17
2.4 Specific FDA Requirements for DV&V Activities .... 18
Chapter 3 Methodology ................................ 21
3.1 Architecture of Integrated Information System, ARIS ...................................................... 21
3.2 R&D Management ................................... 29
Chapter 4 Case Study ................................. 31
4.1 The Case Company ................................. 31
4.2 Feasible Solution ................................ 41
Chapter 5 Conclusion and Suggestion .................. 49
Reference ............................................ 51
參考文獻 [1] M.S. Sivakumar, Valentine Casey, Fergal McCaffery, Gerry Coleman, Improving Verification & Validation in the Medical Device Domain, 2011
[2] Simon C. Mathews, Michael J. McShea, Casey L. Hanley, Alan Ravitz, Alain B. Labrique and Adam B. Cohen, Digital health: a path to validation, 2019
[3] John E. Lincoln, Medical Device Product Verification and Validation, 2010
[4] Berlin Heidelberg, Business Process Engineering, © 1994 Springer-Verlag, 1994
[5] August-Wilhelm Scheer, Markus Nüttgens, ARIS Architecture and Reference Models for Business Process Management, 2002
[6] ISO13485 Medical devices — Quality management systems — Requirements for regulatory purposes, 2016
[7] ISO14971 Medical devices — Application of risk management to medical devices, 2019
[8] IEC62304 Medical device software — Software life cycle processes, 2006
[9] ISO62366-1 Medical devices - Part 1: Application of usability engineering to medical devices, 2015
[10] FD&C Act Section 513, 2023
[11] MDCG 2021-24 Guidance on classification of medical devices, 2021
[12] Medical Device Directive; MDD 93/42/EEC, 1994

Network Reference
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[24] Access2Funding, 2023 https://www.access2funding.co.uk/
[25] ARIS Community, 2023 https://ariscommunity.com/
[26] ARIS Express, 2023 https://en.wikipedia.org/wiki/ARIS_Express
[27] Architecture of Integrated Information Systems, 2023 https://en.wikipedia.org/wiki/Architecture_of_Integrated_Information_Systems#ARIS_house_(description_views)
[28] Enterprise Methodologies, 2023 http://www.pera.net/Methodologies/ARIS/ARIS.html
[29] ITRI, 2023 https://www.itri.org.tw/
[30] Wikipedia, 2023 https://en.wikipedia.org/
指導教授 高信培(H. P. Kao) 審核日期 2023-6-6
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