在合规欧盟、英国和美国法规的情况下编写内部医疗器械软件

English | 2024 | ISBN: 9781003301202 | 291 pages | True PDF | 4.12 MB

This book is a comprehensive guide to producing medical software for routine clinical use. It is a practical guidebook for medical professionals developing software to ensure compliance with medical device regulations for software products intended to be sold commercially, shared with healthcare colleagues in other hospitals, or simply used in-house.

It compares requirements and latest regulations in different global territories, including the most recent EU regulations as well as UK and US regulations.

This book is a valuable resource for practising clinical scientists producing medical software in-house, in addition to other medical staff writing small apps for clinical use, clinical scientist trainees, and software engineers considering a move into healthcare. The academic level is post-graduate, as readers will require a basic knowledge of software engineering principles and practice.

Key Features

Up to date with the latest regulations in the UK, the EU, and the US Useful for those producing medical software for routine clinical use Contains best practice

这本书是一部全面指南，旨在为临床常规使用的医疗软件生产提供帮助。它是一部实用手册，适用于开发软件以确保其符合医疗器械法规的医务人员，该软件旨在进行商业销售、与其他医院的卫生同行共享或仅用于内部使用。 它比较了不同全球地区的标准和最新规定，包括最新的欧盟规定以及英国和美国的规定。 这本书对于在内部生产医疗软件的临床科学家来说是非常宝贵的信息资源，除此之外也适用于其他编写小型应用以供临床使用的医务人员、临床科学家训练生，以及考虑转入医疗行业的软件工程师。读者需要具备基本的软件工程原则与实践知识。 关键特性 最新的英国、欧盟和美国法规 适用于为常规临床使用而生产医疗软件的人士 包含最佳做法

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