Medical-Grade Software Development: How to Build Medical-Device Products That Meet the Requirements of IEC 62304 and ISO 13485
Juuso, Ilkka, Pöyhönen, Ilpo
- 出版商: Productivity Press
- 出版日期: 2023-11-13
- 售價: $2,370
- 貴賓價: 9.5 折 $2,252
- 語言: 英文
- 頁數: 338
- 裝訂: Quality Paper - also called trade paper
- ISBN: 1032594721
- ISBN-13: 9781032594729
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商品描述
This book is a practical guide to meeting IEC 62304 software-development requirements within the context of an ISO 13485 quality management system (QMS). The book proves this can be done with a minimum amount of friction, overlap, and back-and-forth between development stages. It essentially shows you how you should shape your medical-software development processes to fit in with the QMS processes in the smartest and leanest way possible.
By following the advice in this book, you can reuse processes from your QMS, ensure your product-realization processes meet the requirements for medical-software development, and marry all the requirements together using tried and tested solutions into one efficient system. The expertise of the authors here goes beyond just the experiences of one real-world project as they tap into over 30 years of experience and countless software and software-assessment projects to distill their advice.
The book takes a hands-on approach by first teaching you the top 25 lessons to know before starting to develop a process for medical-software development. It then walks you through the expectations placed on the key aspects of such a process by the key standards. The book progresses from an overview of both standards and the general requirements involved to a detailed discussion of the expected stages from software development and maintenance to risk management, configuration management, and problem resolution. The book provides insightful advice on how the requirements of the IEC 62304 software-development life cycle can be married with an ISO 13485 QMS, how the development of the technical file should be organized, and how to address conformity assessment, the daily after-approval, and the recent trends that will affect the industry in the coming years.
The book is modeled after the IEC 62304 standard and adopts its clause structure in the numbering of sections for easy reference. The book does not attempt to replicate either standard. For the ISO 13485 standard, it recites the necessary requirements succinctly. For IEC 62304, the discussion is in-depth and also addresses the impact of ISO 13485 on the requirements discussed. In this way, the book drills into both standards to expose the core of each requirement and shape these into a practical, cohesive workflow for developing, maintaining, and improving a Lean software development pipeline.
商品描述(中文翻譯)
本書是一本實用指南，旨在在 ISO 13485 品質管理體系的框架下滿足 IEC 62304 軟體開發要求。本書證明了在開發階段之間以最少的摩擦、重疊和來回操作完成這一目標是可行的。本書主要展示了如何以最智慧和精簡的方式塑造醫療軟體開發流程，以符合品質管理體系流程。
通過遵循本書的建議，您可以重複使用品質管理體系中的流程，確保您的產品實現流程符合醫療軟體開發的要求，並使用經過驗證的解決方案將所有要求結合成一個高效的系統。作者的專業知識不僅僅來自一個真實項目的經驗，他們還借鑒了超過30年的經驗和無數的軟體和軟體評估項目，將他們的建議提煉出來。
本書採用實踐方法，首先教授您在開發醫療軟體開發流程之前需要了解的前25個重要課程。然後，它將引導您了解關鍵標準對這種流程的期望。本書從概述兩個標準和相關要求開始，逐步深入討論從軟體開發和維護到風險管理、配置管理和問題解決的預期階段。本書提供了有關如何將 IEC 62304 軟體開發生命週期的要求與 ISO 13485 品質管理體系相結合，如何組織技術文件的開發以及如何應對符合評估、批准後的日常工作和未來幾年將影響該行業的最新趨勢的深入見解。
本書以 IEC 62304 標準為模型，採用其條款結構進行編號，以便參考。本書並不試圖複製這兩個標準。對於 ISO 13485 標準，它簡明地列舉了必要的要求。對於 IEC 62304，討論更加深入，並且還討論了 ISO 13485 對所討論要求的影響。通過這種方式，本書深入挖掘了這兩個標準，揭示了每個要求的核心，並將其塑造成一個實用、連貫的工作流程，用於開發、維護和改進精益軟體開發流程。
作者簡介
Dr. Ilkka Juuso, DSc, has 20-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 Senior Advisor with the medical device quality consultancy Kasve, and a post-doctoral researcher with the University of Oulu.
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 CEmarked 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 also the author of the book Developing an ISO 13485-Certified Quality Management System (Routledge 2022).
Ilpo Pöyhönen has 30-plus years of experience working on medical device research, development, testing, and safety &
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 cl.14, IEC 62304, and IEC 82304. 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 interest 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 APS, and cloud services in the context of medical devices.
作者簡介(中文翻譯)
Dr. Ilkka Juuso, DSc，擁有20多年在工業和學術界從事跨學科研發項目的經驗。他是醫療設備初創公司Cerenion的創始人之一，也是醫療設備質量諮詢公司Kasve的高級顧問，以及芬蘭奧盧大學的博士後研究員。
他的主要興趣是國際監管事務、標準化和醫療保健業務發展。他成功領導了一個符合ISO 13485、ISO 14971和IEC 62304標準的質量管理體系（QMS）的開發，並通過了知名機構的認證。他在基於人工智能的CE標記IIb類醫療設備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）重要委員會的委員和芬蘭國家代表團的負責人。他還是書籍《Developing an ISO 13485-Certified Quality Management System》（Routledge 2022）的作者。
Ilpo Pöyhönen在醫療設備研究、開發、測試和安全性及性能評估方面擁有30多年的經驗，包括在認可的認證機構的背景下進行的工作。在此期間，他根據IEC 60601-1-4、IEC 60601-1 cl.14、IEC 62304和IEC 82304進行了約200次軟件評估。在這項工作中，他特別關注可編程數據庫系統的作用以及為不同需求開發測試設備。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監管事務、標準化以及智能控制醫療設備設計過程，以不斷滿足例如網絡安全、可用性工程、風險管理和敏捷開發模型等要求。他對人工智能等新興技術的應用也特別感興趣。
他積極參與研究項目，例如研究在受監管環境中所需的軟件開發文檔、風險管理的影響、風險分析本身作為軟件開發生命週期的一部分以及供應複雜軟件系統的可靠性因素。
他是芬蘭SFS/SR301醫療IT委員會的長期委員，並在醫療設備軟件、風險管理、可用性、mHealth應用程序和醫療設備的雲服務等主題上受到廣泛邀請擔任講師。
