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

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

"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.

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

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.

Artificial Intelligence and Psychiatry

Artificial Intelligence and Psychiatry
Author: D. J. Hand
Publisher: Cambridge University Press
Total Pages: 296
Release: 1985-06-06
Genre: Computers
ISBN: 9780521258715

This book provides the psychiatrist with a basic knowledge of the methods and concepts used in the sphere of artificial intelligence.

Systems Engineering and Artificial Intelligence

Systems Engineering and Artificial Intelligence
Author: William F. Lawless
Publisher: Springer Nature
Total Pages: 566
Release: 2021-11-02
Genre: Computers
ISBN: 3030772837

This book provides a broad overview of the benefits from a Systems Engineering design philosophy in architecting complex systems composed of artificial intelligence (AI), machine learning (ML) and humans situated in chaotic environments. The major topics include emergence, verification and validation of systems using AI/ML and human systems integration to develop robust and effective human-machine teams—where the machines may have varying degrees of autonomy due to the sophistication of their embedded AI/ML. The chapters not only describe what has been learned, but also raise questions that must be answered to further advance the general Science of Autonomy. The science of how humans and machines operate as a team requires insights from, among others, disciplines such as the social sciences, national and international jurisprudence, ethics and policy, and sociology and psychology. The social sciences inform how context is constructed, how trust is affected when humans and machines depend upon each other and how human-machine teams need a shared language of explanation. National and international jurisprudence determine legal responsibilities of non-trivial human-machine failures, ethical standards shape global policy, and sociology provides a basis for understanding team norms across cultures. Insights from psychology may help us to understand the negative impact on humans if AI/ML based machines begin to outperform their human teammates and consequently diminish their value or importance. This book invites professionals and the curious alike to witness a new frontier open as the Science of Autonomy emerges.

Sharing Clinical Trial Data

Sharing Clinical Trial Data
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 236
Release: 2015-04-20
Genre: Medical
ISBN: 0309316324

Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Embedded Systems and Software Validation

Embedded Systems and Software Validation
Author: Abhik Roychoudhury
Publisher: Morgan Kaufmann
Total Pages: 267
Release: 2009-04-29
Genre: Computers
ISBN: 0080921256

Modern embedded systems require high performance, low cost and low power consumption. Such systems typically consist of a heterogeneous collection of processors, specialized memory subsystems, and partially programmable or fixed-function components. This heterogeneity, coupled with issues such as hardware/software partitioning, mapping, scheduling, etc., leads to a large number of design possibilities, making performance debugging and validation of such systems a difficult problem. Embedded systems are used to control safety critical applications such as flight control, automotive electronics and healthcare monitoring. Clearly, developing reliable software/systems for such applications is of utmost importance. This book describes a host of debugging and verification methods which can help to achieve this goal. - Covers the major abstraction levels of embedded systems design, starting from software analysis and micro-architectural modeling, to modeling of resource sharing and communication at the system level - Integrates formal techniques of validation for hardware/software with debugging and validation of embedded system design flows - Includes practical case studies to answer the questions: does a design meet its requirements, if not, then which parts of the system are responsible for the violation, and once they are identified, then how should the design be suitably modified?

Principles of Program Analysis

Principles of Program Analysis
Author: Flemming Nielson
Publisher: Springer
Total Pages: 465
Release: 2015-02-27
Genre: Computers
ISBN: 3662038110

Program analysis utilizes static techniques for computing reliable information about the dynamic behavior of programs. Applications include compilers (for code improvement), software validation (for detecting errors) and transformations between data representation (for solving problems such as Y2K). This book is unique in providing an overview of the four major approaches to program analysis: data flow analysis, constraint-based analysis, abstract interpretation, and type and effect systems. The presentation illustrates the extensive similarities between the approaches, helping readers to choose the best one to utilize.

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

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.