Download or read book Embedded Software Development for Safety Critical Systems Second Edition written by Chris Hobbs and published by CRC Press. This book was released on 2019-08-16 with total page 308 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a book about the development of dependable, embedded software. It is for systems designers, implementers, and verifiers who are experienced in general embedded software development, but who are now facing the prospect of delivering a software-based system for a safety-critical application. It is aimed at those creating a product that must satisfy one or more of the international standards relating to safety-critical applications, including IEC 61508, ISO 26262, EN 50128, EN 50657, IEC 62304, or related standards. Of the first edition, Stephen Thomas, PE, Founder and Editor of FunctionalSafetyEngineer.com said, "I highly recommend Mr. Hobbs' book."

Download or read book The Engineering of Reliable Embedded Systems LPC1769 written by Michael J. Pont and published by Lulu.com. This book was released on 2015-03-30 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the first edition of 'The Engineering of Reliable Embedded Systems': it is released here largely for historical reasons. (Please consider purchasing 'ERES2' instead.) [The second edition will be available for purchase here from June 2017.]

Download or read book Embedded Software Development for Safety Critical Systems written by Chris Hobbs and published by CRC Press. This book was released on 2017-09-07 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: "I highly recommend Mr. Hobbs' book." - Stephen Thomas, PE, Founder and Editor of FunctionalSafetyEngineer.com Safety-critical devices, whether medical, automotive, or industrial, are increasingly dependent on the correct operation of sophisticated software. Many standards have appeared in the last decade on how such systems should be designed and built. Developers, who previously only had to know how to program devices for their industry, must now understand remarkably esoteric development practices and be prepared to justify their work to external auditors. Embedded Software Development for Safety-Critical Systems discusses the development of safety-critical systems under the following standards: IEC 61508; ISO 26262; EN 50128; and IEC 62304. It details the advantages and disadvantages of many architectural and design practices recommended in the standards, ranging from replication and diversification, through anomaly detection to the so-called "safety bag" systems. Reviewing the use of open-source components in safety-critical systems, this book has evolved from a course text used by QNX Software Systems for a training module on building embedded software for safety-critical devices, including medical devices, railway systems, industrial systems, and driver assistance devices in cars. Although the book describes open-source tools for the most part, it also provides enough information for you to seek out commercial vendors if that’s the route you decide to pursue. All of the techniques described in this book may be further explored through hundreds of learned articles. In order to provide you with a way in, the author supplies references he has found helpful as a working software developer. Most of these references are available to download for free.

Download or read book The Medical Device Industry written by John Burton and published by Cambridge Scholars Publishing. This book was released on 2009-03-26 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Medical Device industry is one of the fastest growing industries in the world. Device manufacturers are producing increasingly sophisticated and complex medical device software to differentiate themselves in the battle for dominance in this sector. The increase in the complexity of medical device software has introduced new challenges with respect to making medical devices and their associated software safe. Risk management has emerged as key in addressing these challenges. Existing literature on risk management for medical devices has been slow to adequately account for the complex nature of software in modern medical devices. Conversely, excellent progress has been made in the broader Software Engineering community with the production of holistic software risk based models such as the Capability Maturity Model Integration (CMMI®) and SPICE™. However, these models do not account for medical device specific requirements. This book examines the possibility of a unified approach whilst investigating the relevance of the CMMI® SPI model to the medical device regulatory requirements.

Download or read book Writing In House Medical Device Software in Compliance with EU UK and US Regulations written by Philip S. Cosgriff and published by CRC Press. This book was released on 2024-03-26 with total page 223 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Haemoglobin A1c point of care analysers for professional use written by World Health Organization and published by World Health Organization. This book was released on 2024-01-29 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book SIL and Functional Safety in a Nutshell 2nd Edition written by Michel Houtermans and published by Risknowlogy. This book was released on 2021-10-01 with total page 75 pages. Available in PDF, EPUB and Kindle. Book excerpt: This ebook explains what SIL and functional safety means in a nutshell. The book is intended for everybody who is new to functional safety and SIL and wants to have a full overview without being lost in the details. It is excellent for managers that need to understand quickly what functional safety is all about and how it will influence the work of their employees and their products and/or services. It is excellent for engineers and professionals that want to get started with functional safety and understand the big picture before going into detail. Many standards, guidelines and other publications exist that talk about functional safety. All of them with their own level of detail. This book does not to go into the details of what has to be done according to what standard and what not. It explains main functional safety concepts so that you know everything you need to know to get started. Functional safety is not rocket science and once you understand it and applied it a few times in practice you will notice it is just good engineering practice. This book tries to explain that good engineering practice. Functional safety standards can be confusing and contradicting at times and sometimes they require things that make no sense. You do not need to understand the standards in order to apply and be good at functional safety. If you understand the concepts explained in this book you can apply functional safety into your organisation and to your products, with or without following the exact requirements of standards. Actually once you understand how functional safety works you most likely will go beyond what standards say and create your own functional safety organisation of excellence. And if you do that, well then you are well on your way in becoming a longtime winner as suppose to a short term fuse.

Download or read book Measurement Instrumentation and Sensors Handbook Second Edition written by John G. Webster and published by CRC Press. This book was released on 2014-01-29 with total page 1641 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Second Edition of the bestselling Measurement, Instrumentation, and Sensors Handbook brings together all aspects of the design and implementation of measurement, instrumentation, and sensors. Reflecting the current state of the art, it describes the use of instruments and techniques for performing practical measurements in engineering, physics, chemistry, and the life sciences and discusses processing systems, automatic data acquisition, reduction and analysis, operation characteristics, accuracy, errors, calibrations, and the incorporation of standards for control purposes. Organized according to measurement problem, the Spatial, Mechanical, Thermal, and Radiation Measurement volume of the Second Edition: Contains contributions from field experts, new chapters, and updates to all 96 existing chapters Covers instrumentation and measurement concepts, spatial and mechanical variables, displacement, acoustics, flow and spot velocity, radiation, wireless sensors and instrumentation, and control and human factors A concise and useful reference for engineers, scientists, academic faculty, students, designers, managers, and industry professionals involved in instrumentation and measurement research and development, Measurement, Instrumentation, and Sensors Handbook, Second Edition: Spatial, Mechanical, Thermal, and Radiation Measurement provides readers with a greater understanding of advanced applications.

Download or read book Safety Risk Management for Medical Devices written by Bijan Elahi and published by Academic Press. This book was released on 2021-11-11 with total page 541 pages. Available in PDF, EPUB and Kindle. Book excerpt: Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs. Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations. - Includes new coverage of ISO 14971:2019, ISO/TR 24971 - Presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk management - Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation

Download or read book Medical Device Software Verification Validation and Compliance written by David A. Vogel and published by Artech House. This book was released on 2011 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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."

Download or read book Balancing Agile and Disciplined Engineering and Management Approaches for IT Services and Software Products written by Mora, Manuel and published by IGI Global. This book was released on 2020-07-10 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: The highly dynamic world of information technology service management stresses the benefits of the quick and correct implementation of IT services. A disciplined approach relies on a separate set of assumptions and principles as an agile approach, both of which have complicated implementation processes as well as copious benefits. Combining these two approaches to enhance the effectiveness of each, while difficult, can yield exceptional dividends. Balancing Agile and Disciplined Engineering and Management Approaches for IT Services and Software Products is an essential publication that focuses on clarifying theoretical foundations of balanced design methods with conceptual frameworks and empirical cases. Highlighting a broad range of topics including business trends, IT service, and software development, this book is ideally designed for software engineers, software developers, programmers, information technology professionals, researchers, academicians, and students.

Download or read book Validation of Chromatography Data Systems written by Robert McDowall and published by Royal Society of Chemistry. This book was released on 2016-11-23 with total page 778 pages. Available in PDF, EPUB and Kindle. Book excerpt: Guiding chromatographers working in regulated industries and helping them to validate their chromatography data systems to meet data integrity, business and regulatory needs. This book is a detailed look at the life cycle and documented evidence required to ensure a system is fit for purpose throughout the lifecycle. Initially providing the regulatory, data integrity and system life cycle requirements for computerised system validation, the book then develops into a guide on planning, specifying, managing risk, configuring and testing a chromatography data system before release. This is followed by operational aspects such as training, integration and IT support and finally retirement. All areas are discussed in detail with case studies and practical examples provided as appropriate. The book has been carefully written and is right up to date including recently released FDA data integrity guidance. It provides detailed guidance on good practice and expands on the first edition making it an invaluable addition to a chromatographer’s book shelf.

Download or read book In vitro diagnostic medical devices used for the qualitative detection of SARS CoV 2 nucleic acid written by World Health Organization and published by World Health Organization. This book was released on 2023-10-02 with total page 34 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Medical Grade Software Development written by Ilkka Juuso and published by CRC Press. This book was released on 2023-11-13 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a practical guide to meeting IEC 62304 software-development requirements within the context of an ISO 13485 quality management system (QMS). The book proves this can be done with a minimum amount of friction, overlap, and back-and-forth between development stages. It essentially shows you how you should shape your medical-software development processes to fit in with the QMS processes in the smartest and leanest way possible. By following the advice in this book, you can reuse processes from your QMS, ensure your product-realization processes meet the requirements for medical-software development, and marry all the requirements together using tried and tested solutions into one efficient system. The expertise of the authors here goes beyond just the experiences of one real-world project as they tap into over 30 years of experience and countless software and software-assessment projects to distill their advice. The book takes a hands-on approach by first teaching you the top 25 lessons to know before starting to develop a process for medical-software development. It then walks you through the expectations placed on the key aspects of such a process by the key standards. The book progresses from an overview of both standards and the general requirements involved to a detailed discussion of the expected stages from software development and maintenance to risk management, configuration management, and problem resolution. The book provides insightful advice on how the requirements of the IEC 62304 software-development life cycle can be married with an ISO 13485 QMS, how the development of the technical file should be organized, and how to address conformity assessment, the daily after-approval, and the recent trends that will affect the industry in the coming years. The book is modeled after the IEC 62304 standard and adopts its clause structure in the numbering of sections for easy reference. The book does not attempt to replicate either standard. For the ISO 13485 standard, it recites the necessary requirements succinctly. For IEC 62304, the discussion is in-depth and also addresses the impact of ISO 13485 on the requirements discussed. In this way, the book drills into both standards to expose the core of each requirement and shape these into a practical, cohesive workflow for developing, maintaining, and improving a Lean software development pipeline.

Download or read book Neurorehabilitation Technology written by David J. Reinkensmeyer and published by Springer. This book was released on 2016-08-03 with total page 647 pages. Available in PDF, EPUB and Kindle. Book excerpt: This revised, updated second edition provides an accessible, practical overview of major areas of technical development and clinical application in the field of neurorehabilitation movement therapy. The initial section provides a rationale for technology application in movement therapy by summarizing recent findings in neuroplasticity and motor learning. The following section then explains the state of the art in human-machine interaction requirements for clinical rehabilitation practice. Subsequent sections describe the ongoing revolution in robotic therapy for upper extremity movement and for walking, and then describe other emerging technologies including electrical stimulation, virtual reality, wearable sensors, and brain-computer interfaces. The promises and limitations of these technologies in neurorehabilitation are discussed. Throughout the book the chapters provide detailed practical information on state-of-the-art clinical applications of these devices following stroke, spinal cord injury, and other neurologic disorders. The text is illustrated throughout with photographs and schematic diagrams which serve to clarify the information for the reader. Neurorehabilitation Technology, Second Edition is a valuable resource for neurologists, biomedical engineers, roboticists, rehabilitation specialists, physiotherapists, occupational therapists and those training in these fields.

Download or read book Software Process Improvement written by Rory O'Connor and published by Springer Science & Business Media. This book was released on 2009-08-21 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook is intended for SPI (software process improvement) managers and - searchers, quality managers, and experienced project and research managers. The papers constitute the research proceedings of the 16th EuroSPI (European Software Process Improvement, www.eurospi.net) conference held in Alcala (Madrid region), September 2–4, 2009, Spain. Conferences have been held since 1994 in Dublin, 1995 in Vienna (Austria), 1997 in Budapest (Hungary), 1998 in Gothenburg (Sweden), 1999 in Pori (Finland), 2000 in Copenhagen (Denmark), 2001 in Limerick (Ireland), 2002 in Nuremberg (G- many), 2003 in Graz (Austria), 2004 in Trondheim (Norway), 2005 in Budapest (Hungary), 2006 in Joensuu (Finland), 2007 in Potsdam (Germany), 2008 in Dublin (Ireland), and 2009 in Alcala (Spain). EuroSPI established an experience library (library.eurospi.net) which will be conti- ously extended over the next few years and will be made available to all attendees. EuroSPI also created an umbrella initiative for establishing a European Qualification Network in which different SPINs and national initiatives join mutually beneficial collaborations (ECQA – European Certification and Qualification Association, www.ecqa.org). With a general assembly during October 15–16, 2007 through Euro-SPI partners and networks, in collaboration with the European Union (supported by the EU L- nardo da Vinci Programme) a European certification association has been created (www.eu-certificates.org, www.ecqa.org) for the IT and services sector to offer SPI knowledge and certificates to industry, establishing close knowledge transfer links between research and industry.

Download or read book Software Technology written by Mike Hinchey and published by John Wiley & Sons. This book was released on 2018-07-09 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive collection of influential articles from one of IEEE Computer magazine’s most popular columns This book is a compendium of extended and revised publications that have appeared in the “Software Technologies” column of IEEE Computer magazine, which covers key topics in software engineering such as software development, software correctness and related techniques, cloud computing, self-managing software and self-aware systems. Emerging properties of software technology are also discussed in this book, which will help refine the developing framework for creating the next generation of software technologies and help readers predict future developments and challenges in the field. Software Technology provides guidance on the challenges of developing software today and points readers to where the best advances are being made. Filled with one insightful article after another, the book serves to inform the conversation about the next wave of software technology advances and applications. In addition, the book: Introduces the software landscape and challenges associated with emerging technologies Covers the life cycle of software products, including concepts, requirements, development, testing, verification, evolution, and security Contains rewritten and updated articles by leaders in the software industry Covers both theoretical and practical topics Informative and thought-provoking throughout, Software Technology is a valuable book for everyone in the software engineering community that will inspire as much as it will teach all who flip through its pages.