Writing In-House Medical Device Software in Compliance with Eu, Uk, and Us Regulations
暫譯: 遵循歐盟、英國和美國法規的內部醫療設備軟體開發

這本書是針對日常臨床使用的醫療軟體製作的全面指南。它是一本實用的手冊，專為開發軟體的醫療專業人員而設，旨在確保符合醫療器械法規，適用於計劃商業銷售、與其他醫院的醫療同事共享或僅在內部使用的軟體產品。

本書比較了不同全球地區的要求和最新法規，包括最新的歐盟法規以及英國和美國的法規。

這本書對於在內部製作醫療軟體的臨床科學家來說是一個寶貴的資源，此外也適合為臨床使用編寫小型應用程式的其他醫療人員、臨床科學家實習生以及考慮轉向醫療領域的軟體工程師。學術水平為研究生級別，因為讀者需要具備基本的軟體工程原則和實踐知識。

主要特點：

- 與英國、歐盟和美國的最新法規保持一致
- 對於製作日常臨床使用的醫療軟體的人士非常有用
- 包含最佳實踐

Philip S. Cosgriff worked as a clinical scientist (medical physicist) in the UK National Health Service for nearly 40 years, specialising mainly in nuclear medicine. He produced in-house data analysis software for that whole period, with an emphasis on software quality assurance. He was a UK delegate on a pioneering EU project (COST-B2) on quality assurance of nuclear medicine software, and he has contributed to numerous reports published by the UK Institute of Physics and Engineering in Medicine (IPEM). He retired from the NHS in 2016 but has remained professionally active, with continued contributions to IPEM publications and a chapter in a recently published book entitled Diagnostic Radiology Physics with MATLAB(R). He is a recognised expert on the application of EU and US medical device legislation, as well as other consumer protection legislation that may affect the in-house medical software developer. His current interests include the application of AI methodologies to diagnostic imaging and the future role of medical apps.

Matthew J. Memmott is a consultant medical physicist based at Manchester University NHS Foundation Trust, with experience working as a clinical scientist in the UK National Health Service for over 15 years. He has previously published journal articles, book chapters and delivered talks at national and international conferences on topics ranging from Monte Carlo image generation, computational phantoms and cardiac positron emission tomography (PET-CT) optimisation to dosimetry for radiation accident scenarios. He has a long-standing interest in scientific programming, utilising various languages for analysis and simulation of ground truth quality assurance data; and commercial platforms for the development of in-house clinical applications. He was a previous Chair of the UK Institute of Physics and Engineering in Medicine (IPEM) Nuclear Medicine Software Quality Group (NMSQG); a group which develops national audits to promote quality standards across departments utilising in-house developed software, as well as commercial packages. His current interests are in modelling exposure scenarios from radiation accidents, developing ground-truth computational phantoms for software quality assurance, investigating novel quantitative methods in PET-CT studies and the potential applications of AI in nuclear medicine.

Philip S. Cosgriff 在英國國民健康服務系統擔任臨床科學家（醫學物理學家）近40年，主要專注於核醫學。在這段期間，他開發了內部數據分析軟體，並強調軟體質量保證。他曾是英國代表參加一個開創性的歐盟項目（COST-B2），該項目專注於核醫學軟體的質量保證，並為英國物理學與醫學工程學會（IPEM）發表的多份報告做出了貢獻。他於2016年從國民健康服務系統退休，但仍然保持專業活躍，持續為IPEM出版物貢獻內容，並在最近出版的書籍《Diagnostic Radiology Physics with MATLAB(R)》中撰寫了一章。他是歐盟和美國醫療器械法規應用的公認專家，以及可能影響內部醫療軟體開發者的其他消費者保護法規。他目前的興趣包括將人工智慧方法應用於診斷影像以及醫療應用程式的未來角色。

Matthew J. Memmott 是一位顧問醫學物理學家，工作於曼徹斯特大學國民健康服務基金會，擁有超過15年的英國國民健康服務臨床科學家經驗。他曾發表期刊文章、書籍章節，並在國內外會議上就從蒙特卡羅影像生成、計算幻影和心臟正電子發射斷層掃描（PET-CT）優化到輻射事故情境的劑量測定等主題進行演講。他對科學編程有長期興趣，利用各種語言分析和模擬真實質量保證數據；並使用商業平台開發內部臨床應用程式。他曾擔任英國物理學與醫學工程學會（IPEM）核醫學軟體質量小組（NMSQG）的主席；該小組負責開發全國審核，以促進使用內部開發軟體及商業套件的部門之間的質量標準。他目前的興趣包括模擬輻射事故的暴露情境、開發用於軟體質量保證的真實計算幻影、研究PET-CT研究中的新型定量方法，以及人工智慧在核醫學中的潛在應用。