HereOCOs 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 you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your softwareOCOs safety and effectiveness. The book presents validation activities for each phase of the development 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, in compliance with regulations."

Systems' Verification Validation and Testing (VVT) are carried out throughout systems' lifetimes. Notably, quality-cost expended on performing VVT activities and correcting system defects consumes about half of the overall engineering cost. Verification, Validation and Testing of Engineered Systems provides a comprehensive compendium of VVT activities and corresponding VVT methods for implementation throughout the entire lifecycle of an engineered system. In addition, the book strives to alleviate the fundamental testing conundrum, namely: What should be tested? How should one test? When should one test? And, when should one stop testing? In other words, how should one select a VVT strategy and how it be optimized? The book is organized in three parts: The first part provides introductory material about systems and VVT concepts. This part presents a comprehensive explanation of the role of VVT in the process of engineered systems (Chapter-1). The second part describes 40 systems' development VVT activities (Chapter-2) and 27 systems' post-development activities (Chapter-3). Corresponding to these activities, this part also describes 17 non-testing systems' VVT methods (Chapter-4) and 33 testing systems' methods (Chapter-5). The third part of the book describes ways to model systems’ quality cost, time and risk (Chapter-6), as well as ways to acquire quality data and optimize the VVT strategy in the face of funding, time and other resource limitations as well as different business objectives (Chapter-7). Finally, this part describes the methodology used to validate the quality model along with a case study describing a system’s quality improvements (Chapter-8). Fundamentally, this book is written with two categories of audience in mind. The first category is composed of VVT practitioners, including Systems, Test, Production and Maintenance engineers as well as first and second line managers. The second category is composed of students and faculties of Systems, Electrical, Aerospace, Mechanical and Industrial Engineering schools. This book may be fully covered in two to three graduate level semesters; although parts of the book may be covered in one semester. University instructors will most likely use the book to provide engineering students with knowledge about VVT, as well as to give students an introduction to formal modeling and optimization of VVT strategy.

This book presents Systems Engineering from a modern, multidisciplinary engineering approach, providing the understanding that all aspects of systems design, systems, software, test, security, maintenance and the full life-cycle must be factored in to any large-scale system design; up front, not factored in later. It lays out a step-by-step approach to systems-of-systems architectural design, describing in detail the documentation flow throughout the systems engineering design process. It provides a straightforward look and the entire systems engineering process, providing realistic case studies, examples, and design problems that will enable students to gain a firm grasp on the fundamentals of modern systems engineering. Included is a comprehensive design problem that weaves throughout the entire text book, concluding with a complete top-level systems architecture for a real-world design problem.

This book explores the domain of software maintenance management and provides road maps for improving software maintenance organizations. It describes full maintenance maturity models organized by levels 1, 2, and 3, which allow for benchmarking and continuous improvement paths. Goals for each key practice area are also provided, and the model presented is fully aligned with the architecture and framework of software development maturity models of CMMI and ISO 15504. It is complete with case studies, figures, tables, and graphs.

Software Engineering: Architecture-driven Software Development is the first comprehensive guide to the underlying skills embodied in the IEEE's Software Engineering Body of Knowledge (SWEBOK) standard. Standards expert Richard Schmidt explains the traditional software engineering practices recognized for developing projects for government or corporate systems. Software engineering education often lacks standardization, with many institutions focusing on implementation rather than design as it impacts product architecture. Many graduates join the workforce with incomplete skills, leading to software projects that either fail outright or run woefully over budget and behind schedule. Additionally, software engineers need to understand system engineering and architecture—the hardware and peripherals their programs will run on. This issue will only grow in importance as more programs leverage parallel computing, requiring an understanding of the parallel capabilities of processors and hardware. This book gives both software developers and system engineers key insights into how their skillsets support and complement each other. With a focus on these key knowledge areas, Software Engineering offers a set of best practices that can be applied to any industry or domain involved in developing software products. - A thorough, integrated compilation on the engineering of software products, addressing the majority of the standard knowledge areas and topics - Offers best practices focused on those key skills common to many industries and domains that develop software - Learn how software engineering relates to systems engineering for better communication with other engineering professionals within a project environment

In light of the rising cost of healthcare and the overall challenges associated with delivering quality care to patients across regions, scientists and pharmacists are exploring new initiatives in drug discovery and design. One such initiative is the adoption of information technology and software applications to improve healthcare and pharmaceutical processes. Software Innovations in Clinical Drug Development and Safety is a comprehensive resource analyzing the integration of software engineering for the purpose of drug discovery, clinical trials, genomics, and drug safety testing. Taking a multi-faceted approach to the application of computational methods to pharmaceutical science, this publication is ideal for healthcare professionals, pharmacists, computer scientists, researchers, and students seeking the latest information on the architecture and design of software in clinical settings, the impact of clinical technologies on business models, and the safety and privacy of patients and patient data. This timely resource features a well-rounded discussion on topics pertaining to the integration of computational methods in pharmaceutical science and practice including, the impact of software integration on business models, patient safety concerns, software architecture and design, and data security.

The book is based on the "best practices" of the UT Software Quality Institute Software Project Management certificates program. Quality Software Project Management identifies and teaches 34 essential project management competencies project managers can use to minimize cost, risk, and time-to-market. Covers the entire project lifecycle: planning. initiation, monitoring/control, and closing. Illuminates its techniques with real-world software management case studies. Authors (leading practitioners) address the pillars of any successful software venture: process, project, and people. Endorsed by the Software Quality Institute.