Here's the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software. Offering a much broader, higher-level picture than other books in this field, this book helps professionals think critically about software validation -- to build confidence in their software's safety and effectiveness. The book presents validation activities for each phase of the product lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process. From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, and in compliance with regulations.
The book is about a very active research field in software engineering. In modern society, the fact of the world's high reliance on software requires the system's robustness, i.e., continual availability and satisfactory service quality. This requirement gives rise to the popularity of the research on the self-adaptive software in open environment. There are some academic conferences dedicated to this field. But there is a lack of monographs about the topic. We believe such need is unmet in marketplace. By publishing the book, it can help bridge the gap and bring benefits to readers thereof. Key Features:
Software quality stems from two distinctive, but associated, topics in software engineering: software functional quality and software structural quality. Software Quality Engineering studies the tenets of both of these notions, which focus on the efficiency and value of a design, respectively. The text addresses engineering quality on both the application and system levels with attention to Information Systems and Embedded Systems as well as recent developments. Targeted at graduate engineering students and software quality specialists, the book analyzes the relationship between functionality and quality with practical applications to related ISO/IEC JTCI SC7 standards.
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