Medical-Device Usability: Human Factors for Medical Device Development
暫譯: 醫療設備可用性：醫療設備開發的人因因素
Juuso, Ilkka, Pöyhönen, Ilpo
- 出版商: Productivity Press
- 出版日期: 2026-02-06
- 售價: $2,880
- 貴賓價: 9.8 折 $2,822
- 語言: 英文
- 頁數: 317
- 裝訂: Quality Paper - also called trade paper
- ISBN: 1041085052
- ISBN-13: 9781041085058
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相關分類:
設計需求 Requirement
海外代購書籍(需單獨結帳)
相關主題
商品描述
This book simplifies the process regarding the application of usability to medical devices for new developers by providing a thought-out walkthrough of what is involved and how the expectations from the essential standards affect their work and why. Based on the authors' experiences, the information in the book provides other more seasoned experts with a wealth of insight and nuggets of new perspectives on addressing the usability of medical devices, particularly medical software.
The discussion in the book is rooted in recent real-world experiences from both the manufacturer and assessment body sides--the authors provide a novel high-level "roadmap" to using usability engineering to guide development activities from initial conceptual design to research, development, and ultimately release of a medical device. They build toward this map throughout the book and ultimately present the full model. This roadmap is the result of the authors' experiences of taking a research project and launching both a medical device and a medical device business after obtaining all the necessary regulatory approvals.
The book helps product developers to understand the usability requirements around their own work, and to also better understand their users and to present the expected usability information in a way that is readily understood by the auditors. Managers of such work will also greatly benefit from the discussion of the required deliverables and the goals of the usability activities.
Finally, the authors ease the divide between manufacturers and healthcare professionals using medical devices. By simultaneously showing the requirements for the manufacturer's development process and also discussing the realities of work on the healthcare side, the authors facilitate collaboration.
商品描述(中文翻譯)
這本書簡化了新開發者在醫療設備上應用可用性過程的步驟，提供了一個經過深思熟慮的指導，說明了涉及的內容以及基本標準的期望如何影響他們的工作及其原因。根據作者的經驗，書中的資訊為其他更有經驗的專家提供了豐富的見解和新的觀點，特別是在解決醫療設備的可用性，尤其是醫療軟體方面。
書中的討論根植於製造商和評估機構的近期實際經驗——作者提供了一個新穎的高層次「路線圖」，用於利用可用性工程指導從初步概念設計到研究、開發，最終釋放醫療設備的開發活動。他們在整本書中逐步構建這個地圖，最終呈現完整的模型。這個路線圖是作者在完成所有必要的法規批准後，將一個研究項目轉化為醫療設備和醫療設備業務的經驗結果。
這本書幫助產品開發者理解他們工作周圍的可用性要求，並更好地理解他們的用戶，並以審核者易於理解的方式呈現預期的可用性資訊。從事此類工作的管理者也將從有關所需交付物和可用性活動目標的討論中獲益良多。
最後，作者縮小了製造商與使用醫療設備的醫療專業人員之間的鴻溝。通過同時展示製造商開發過程的要求，並討論醫療方面工作的現實，作者促進了合作。
作者簡介
Dr. Ilkka Juuso, DSc, has 25-plus years of experience working on multidisciplinary R&D projects in both industry and academia. He is one of the founders of the medical- device startup Cerenion, a former senior advisor and principal regulatory engineer at the medical-device quality consultancy Kasve, and a post- doctoral researcher with the University of Oulu in Finland. Today he works as a lead auditor at the European notified body SGS Fimko (NB 0598) on conformity assessments according to the EU 2017/ 745 ("MDR") and international standards.
His main interests are international regulatory affairs, standardization, and healthcare business development. He has successfully led the development of an ISO 13485, ISO 14971, and IEC 62304 compliant Quality Management System (QMS) from the ground up, its subsequent day-to-day operation, and certification by a notified body. He has had a key role in the launch of a CE-marked Class IIb medical device based on artificial intelligence.
He has repeatedly served as a committee member and the head of the Finnish national delegation in key committees of the International Organization for Standardization (ISO). He is a member of the management team for CEN TC 251 on health informatics, and secretary for its WGII on technology and applications. He is a member of the CEN/ CENELEC Strategic Advisory Group on Healthcare and a member of the RAPS Nordic LNG leadership team. He is an active member of the Finnish Standards Association (SFS) and the industry forum Healthtech Finland, and a frequent visitor to International Medical Device Regulators (IMDRF) meetings. He is also the author of the books Developing an ISO 13485-Certified Quality Management System (Routledge 2022) and Medical-Grade Software Development (Routledge 2024) - and approximately 3,500 film reviews, which probably explains some of the film references in this book.
Ilpo Pöyhönen has 30-plus years of experience working on medical device research, development, testing, and safety and performance evaluation including in the context of an accredited certification body. During that time, he has performed approximately 200 software evaluations according to IEC 60601-1-4, IEC 60601-1 Clause 14, IEC 62304, and IEC 82304-1. His particular areas of interest in this work have been the role of programmable database systems and the development of test equipment for diverse needs.The work has taken him across the globe and even to the edge of space.Today his main interests are international regulatory affairs, standardization, and the intelligent control of medical device design processes to continuously meet the requirements imposed by, for example, cyber security, usability engineering, risk management, and agile development models. The use of emerging technologies, such as artificial intelligence, also holds special appeal to him.
He has been active in research initiatives that have, for example, examined the software development documentation required in a regulated environment, the impact of risk management, the performance of risk analysis itself as part of the software development life cycle, and the reliability factors involved in the supply of complex software systems.
He is a long-time committee member of SFS/ SR301 on healthcare IT and a sought-after lecturer on topics such as medical device software, risk management, usability, mHealth apps, and cloud services in the context of medical devices. He is also the co-author of the book Medical-Grade Software Development (Routledge 2024).
作者簡介(中文翻譯)
伊爾卡·尤索博士 (Dr. Ilkka Juuso, DSc) 擁有超過 25 年的經驗，曾在產業和學術界從事多學科的研發專案。他是醫療器材新創公司 Cerenion 的創始人之一，曾擔任醫療器材品質顧問公司 Kasve 的高級顧問及主要法規工程師，並在芬蘭奧盧大學擔任博士後研究員。如今，他在歐洲公告機構 SGS Fimko (NB 0598) 擔任首席審核員，負責根據 EU 2017/745（'MDR'）及國際標準進行合規評估。
他的主要興趣包括國際法規事務、標準化及醫療保健業務發展。他成功地從零開始主導開發符合 ISO 13485、ISO 14971 和 IEC 62304 的品質管理系統 (QMS)，並負責其日常運作及由公告機構的認證。他在基於人工智慧的 CE 標記 IIb 類醫療器材的推出中扮演了關鍵角色。
他曾多次擔任國際標準化組織 (ISO) 重要委員會的委員及芬蘭國家代表團的負責人。他是 CEN TC 251 健康資訊學管理團隊的成員，並擔任其 WGII 技術與應用的秘書。他也是 CEN/CENELEC 醫療保健戰略諮詢小組的成員，以及 RAPS 北歐 LNG 領導團隊的成員。他是芬蘭標準協會 (SFS) 的活躍成員，並參與產業論壇 Healthtech Finland，經常參加國際醫療器材監管機構 (IMDRF) 的會議。他還是書籍 開發 ISO 13485 認證的品質管理系統 (Routledge 2022) 和 醫療級軟體開發 (Routledge 2024) 的作者，以及約 3,500 篇影評的撰寫者，這或許解釋了本書中某些影視參考的來源。
伊爾波·佩尤霍寧 (Ilpo Pöyhönen) 擁有超過 30 年的醫療器材研究、開發、測試及安全與性能評估的經驗，包括在認證機構的背景下。在此期間，他根據 IEC 60601-1-4、IEC 60601-1 第 14 條、IEC 62304 和 IEC 82304-1 進行了約 200 次軟體評估。他在這項工作中特別關注可編程資料庫系統的角色及為多樣需求開發測試設備。這項工作使他走遍全球，甚至到達太空邊緣。如今，他的主要興趣是國際法規事務、標準化，以及智能控制醫療器材設計流程，以持續滿足例如網路安全、可用性工程、風險管理和敏捷開發模型等所施加的要求。他對於新興技術，如人工智慧，特別感興趣。
他積極參與研究計畫，例如檢視在受規範環境中所需的軟體開發文件、風險管理的影響、風險分析本身在軟體開發生命週期中的表現，以及供應複雜軟體系統所涉及的可靠性因素。
他是 SFS/SR301 醫療保健 IT 委員會的長期委員，並且是醫療器材軟體、風險管理、可用性、mHealth 應用程式及醫療器材相關雲服務等主題的受歡迎講者。他也是書籍 醫療級軟體開發 (Routledge 2024) 的共同作者。
