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Medical Device Software Verification, Validation and Compliance

Medical Device Software Verification, Validation and Compliance
Author: David A. Vogel
Publisher: Artech House
Total Pages: 445
Release: 2011
Genre: Medical
ISBN: 1596934239

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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."


Verification, Validation and Testing in Software Engineering

Verification, Validation and Testing in Software Engineering
Author: Aristides Dasso
Publisher: IGI Global
Total Pages: 443
Release: 2007-01-01
Genre: Computers
ISBN: 1591408512

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"This book explores different applications in V & V that spawn many areas of software development -including real time applications- where V & V techniques are required, providing in all cases examples of the applications"--Provided by publisher.


An Assessment of Space Shuttle Flight Software Development Processes

An Assessment of Space Shuttle Flight Software Development Processes
Author: National Research Council
Publisher: National Academies Press
Total Pages: 207
Release: 1993-02-01
Genre: Science
ISBN: 030904880X

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Effective software is essential to the success and safety of the Space Shuttle, including its crew and its payloads. The on-board software continually monitors and controls critical systems throughout a Space Shuttle flight. At NASA's request, the committee convened to review the agency's flight software development processes and to recommend a number of ways those processes could be improved. This book, the result of the committee's study, evaluates the safety, oversight, and management functions that are implemented currently in the Space Shuttle program to ensure that the software is of the highest quality possible. Numerous recommendations are made regarding safety and management procedures, and a rationale is offered for continuing the Independent Verification and Validation effort that was instituted after the Challenger Accident.


Software Verification and Validation

Software Verification and Validation
Author: Marcus S. Fisher
Publisher: Springer Science & Business Media
Total Pages: 178
Release: 2007-12-03
Genre: Computers
ISBN: 0387479392

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This book fills the critical need for an in-depth technical reference providing the methods and techniques for building and maintaining confidence in many varities of system software. The intent is to help develop reliable answers to such critical questions as: 1) Are we building the right software for the need? and 2) Are we building the software right? Software Verification and Validation: An Engineering and Scientific Approach is structured for research scientists and practitioners in industry. The book is also suitable as a secondary textbook for advanced-level students in computer science and engineering.


Verification and Validation in Scientific Computing

Verification and Validation in Scientific Computing
Author: William L. Oberkampf
Publisher: Cambridge University Press
Total Pages: 782
Release: 2010-10-14
Genre: Computers
ISBN: 1139491768

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Advances in scientific computing have made modelling and simulation an important part of the decision-making process in engineering, science, and public policy. This book provides a comprehensive and systematic development of the basic concepts, principles, and procedures for verification and validation of models and simulations. The emphasis is placed on models that are described by partial differential and integral equations and the simulations that result from their numerical solution. The methods described can be applied to a wide range of technical fields, from the physical sciences, engineering and technology and industry, through to environmental regulations and safety, product and plant safety, financial investing, and governmental regulations. This book will be genuinely welcomed by researchers, practitioners, and decision makers in a broad range of fields, who seek to improve the credibility and reliability of simulation results. It will also be appropriate either for university courses or for independent study.


Verification, Validation, and Testing of Engineered Systems

Verification, Validation, and Testing of Engineered Systems
Author: Avner Engel
Publisher: John Wiley & Sons
Total Pages: 723
Release: 2010-11-19
Genre: Technology & Engineering
ISBN: 1118029313

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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.


Software Quality Approaches: Testing, Verification, and Validation

Software Quality Approaches: Testing, Verification, and Validation
Author: Michael Haug
Publisher: Springer Science & Business Media
Total Pages: 308
Release: 2012-12-06
Genre: Computers
ISBN: 364256612X

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C. Amting Directorate General Information Society, European Commission, Brussels th Under the 4 Framework of European Research, the European Systems and Soft ware Initiative (ESSI) was part ofthe ESPRIT Programme. This initiative funded more than 470 projects in the area ofsoftware and system process improvements. The majority of these projects were process improvement experiments carrying out and taking up new development processes, methods and technology within the software development process ofa company. In addition, nodes (centres ofexper tise), European networks (organisations managing local activities), training and dissemination actions complemented the process improvementexperiments. ESSI aimed at improving the software development capabilities of European enterprises. It focused on best practice and helped European companies to develop world class skills and associated technologies to build the increasingly complex and varied systems needed to compete in the marketplace. The dissemination activities were designed to build a forum, at European level, to exchange information and knowledge gained within process improvement ex periments. Their major objective was to spread the message and the results of experiments to awider audience, through a variety ofdifferent channels. The European Experience Exchange ~UR~X) project has been one ofthese dis semination activities within the European Systems and Software Initiative.~UR~)( has collected the results of practitioner reports from numerous workshops in Europe and presents, in this series of books, the results of Best Practice achieve ments in European Companies over the last few years.


Reference Information for the Software Verification and Validation Process

Reference Information for the Software Verification and Validation Process
Author: Dolores R. Wallace
Publisher: DIANE Publishing
Total Pages: 97
Release: 1996
Genre: Computer software
ISBN: 0788143409

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Computing systems are employed in the health care environment in efforts to increase reliability of care and reduce costs. Software verification and validation (V&V) is an aid in determining that the software requirements are implemented correctly and completely and are traceable to system requirements. It helps to ensure that those system functions controlled by software are secure, reliable, and maintainable. Software V&V is conducted throughout the planning, development and maintenance of software systems, including knowledge based systems, and may assist in assuring appropriate reuse of software.


Verification and Validation in Systems Engineering

Verification and Validation in Systems Engineering
Author: Mourad Debbabi
Publisher: Springer Science & Business Media
Total Pages: 261
Release: 2010-11-16
Genre: Computers
ISBN: 3642152287

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At the dawn of the 21st century and the information age, communication and c- puting power are becoming ever increasingly available, virtually pervading almost every aspect of modern socio-economical interactions. Consequently, the potential for realizing a signi?cantly greater number of technology-mediated activities has emerged. Indeed, many of our modern activity ?elds are heavily dependant upon various underlying systems and software-intensive platforms. Such technologies are commonly used in everyday activities such as commuting, traf?c control and m- agement, mobile computing, navigation, mobile communication. Thus, the correct function of the forenamed computing systems becomes a major concern. This is all the more important since, in spite of the numerous updates, patches and ?rmware revisions being constantly issued, newly discovered logical bugs in a wide range of modern software platforms (e. g. , operating systems) and software-intensive systems (e. g. , embedded systems) are just as frequently being reported. In addition, many of today’s products and services are presently being deployed in a highly competitive environment wherein a product or service is succeeding in most of the cases thanks to its quality to price ratio for a given set of features. Accordingly, a number of critical aspects have to be considered, such as the ab- ity to pack as many features as needed in a given product or service while c- currently maintaining high quality, reasonable price, and short time -to- market.