Medical Device Software Software Life Cycle Processes

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Medical Device Software Verification, Validation and Compliance

Author : David A. Vogel
Publisher : Artech House
ISBN 13 : 1596934239
Total Pages : 445 pages
Book Rating : 4.5/5 (969 download)

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Book Synopsis Medical Device Software Verification, Validation and Compliance by : David A. Vogel

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."

Software Process Improvement and Capability Determination

Author : Paul M. Clarke
Publisher : Springer
ISBN 13 : 3319389807
Total Pages : 447 pages
Book Rating : 4.3/5 (193 download)

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Book Synopsis Software Process Improvement and Capability Determination by : Paul M. Clarke

Download or read book Software Process Improvement and Capability Determination written by Paul M. Clarke and published by Springer. This book was released on 2016-05-11 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed proceedings of the 16th International Conference on Software Process Improvement and Capability Determination, SPICE 2016, held in Dublin, Ireland, in June 2016. The 28 full papers presented together with 5 short papers were carefully reviewed and selected from 52 submissions. The papers are organized in the following topical sections: SPI in regulated and safety critical domains; gamification and education issues in SPI; SPI in agile and small settings; SPI and assessment; SPI and project management concerns; empirical research case studies of SPI; knowledge and human communications issues in SPI.

Software Process Improvement and Capability Determination

Author : Tanja Woronowicz
Publisher : Springer
ISBN 13 : 3642388337
Total Pages : 278 pages
Book Rating : 4.6/5 (423 download)

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Book Synopsis Software Process Improvement and Capability Determination by : Tanja Woronowicz

Download or read book Software Process Improvement and Capability Determination written by Tanja Woronowicz and published by Springer. This book was released on 2013-05-21 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed proceedings of the 13th International Conference on Software Process Improvement and Capability Determination, SPICE 2013, held in Bremen, Germany, in June 2013. The 21 revised full papers presented and 7 short papers were carefully reviewed and selected from numerous submissions. The papers are organized in topical sections on process quality; medical device software processes; design and use of process models; studies of software development; agile development; IT service management; assessment for diagnosis.

Software Process Improvement and Capability Determination

Author : Antonia Mas
Publisher : Springer
ISBN 13 : 3319673831
Total Pages : 527 pages
Book Rating : 4.3/5 (196 download)

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Book Synopsis Software Process Improvement and Capability Determination by : Antonia Mas

Download or read book Software Process Improvement and Capability Determination written by Antonia Mas and published by Springer. This book was released on 2017-09-08 with total page 527 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed proceedings of the 17th International Conference on Software Process Improvement and Capability Determination, SPICE 2017, held in Palma de Mallorca, Spain, in October 2017. The 34 full papers presented together with 4 short papers were carefully reviewed and selected from 65 submissions. The papers are organized in the following topical sections: SPI in agile approaches; SPI in small settings; SPI and assessment; SPI and models; SPI and functional safety; SPI in various settings; SPI and gamification; SPI case studies; strategic and knowledge issues in SPI; education issues in SPI.

Software Process Improvement and Capability Determination

Author : Terry Rout
Publisher : Springer
ISBN 13 : 3319198602
Total Pages : 254 pages
Book Rating : 4.3/5 (191 download)

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Book Synopsis Software Process Improvement and Capability Determination by : Terry Rout

Download or read book Software Process Improvement and Capability Determination written by Terry Rout and published by Springer. This book was released on 2015-06-02 with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed proceedings of the 15th International Conference on Software Process Improvement and Capability Determination, SPICE 2015, held in Gothenburg, Sweden, in June 2015. The 17 revised full papers presented together with three short papers were carefully reviewed and selected from 48 submissions. The papers are organized in topical sections on industrial frameworks; implementation and assessment; process improvement; agile processes; assessment and maturity models; process and education.

Software Process Improvement and Capability Determination

Author : Rory O'Connor
Publisher : Springer Science & Business Media
ISBN 13 : 3642212328
Total Pages : 257 pages
Book Rating : 4.6/5 (422 download)

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Book Synopsis Software Process Improvement and Capability Determination by : Rory O'Connor

Download or read book Software Process Improvement and Capability Determination written by Rory O'Connor and published by Springer Science & Business Media. This book was released on 2011-05-20 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed proceedings of the 11th International Conference on Software Process Improvement and Capability Determination, SPICE 2011, held in Dublin, Ireland, in May/June 2011. The 15 revised full papers presented and 15 short papers were carefully reviewed and selected from numerous submissions. The papers are organized in topical sections on process modelling and assessment, safety and security, medi SPICE, high maturity, implementation and improvement.

Software Process Definition and Management

Author : Jürgen Münch
Publisher : Springer Science & Business Media
ISBN 13 : 364224291X
Total Pages : 254 pages
Book Rating : 4.6/5 (422 download)

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Book Synopsis Software Process Definition and Management by : Jürgen Münch

Download or read book Software Process Definition and Management written by Jürgen Münch and published by Springer Science & Business Media. This book was released on 2012-05-27 with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt: The concept of processes is at the heart of software and systems engineering. Software process models integrate software engineering methods and techniques and are the basis for managing large-scale software and IT projects. High product quality routinely results from high process quality. Software process management deals with getting and maintaining control over processes and their evolution. Becoming acquainted with existing software process models is not enough, though. It is important to understand how to select, define, manage, deploy, evaluate, and systematically evolve software process models so that they suitably address the problems, applications, and environments to which they are applied. Providing basic knowledge for these important tasks is the main goal of this textbook. Münch and his co-authors aim at providing knowledge that enables readers to develop useful process models that are suitable for their own purposes. They start with the basic concepts. Subsequently, existing representative process models are introduced, followed by a description of how to create individual models and the necessary means for doing so (i.e., notations and tools). Lastly, different possible usage scenarios for process management are highlighted (e.g. process improvement and software process simulation). Their book is aimed at students and researchers working on software project management, software quality assurance, and software measurement; and at practitioners who are interested in process definition and management for developing, maintaining, and operating software-intensive systems and services.

Scaling Software Agility

Author : Dean Leffingwell
Publisher : Pearson Education
ISBN 13 : 0321630068
Total Pages : 635 pages
Book Rating : 4.3/5 (216 download)

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Book Synopsis Scaling Software Agility by : Dean Leffingwell

Download or read book Scaling Software Agility written by Dean Leffingwell and published by Pearson Education. This book was released on 2007-02-26 with total page 635 pages. Available in PDF, EPUB and Kindle. Book excerpt: “Companies have been implementing large agile projects for a number of years, but the ‘stigma’ of ‘agile only works for small projects’ continues to be a frequent barrier for newcomers and a rallying cry for agile critics. What has been missing from the agile literature is a solid, practical book on the specifics of developing large projects in an agile way. Dean Leffingwell’s book Scaling Software Agility fills this gap admirably. It offers a practical guide to large project issues such as architecture, requirements development, multi-level release planning, and team organization. Leffingwell’s book is a necessary guide for large projects and large organizations making the transition to agile development.” —Jim Highsmith, director, Agile Practice, Cutter Consortium, author of Agile Project Management “There’s tension between building software fast and delivering software that lasts, between being ultra-responsive to changes in the market and maintaining a degree of stability. In his latest work, Scaling Software Agility, Dean Leffingwell shows how to achieve a pragmatic balance among these forces. Leffingwell’s observations of the problem, his advice on the solution, and his description of the resulting best practices come from experience: he’s been there, done that, and has seen what’s worked.” —Grady Booch, IBM Fellow Agile development practices, while still controversial in some circles, offer undeniable benefits: faster time to market, better responsiveness to changing customer requirements, and higher quality. However, agile practices have been defined and recommended primarily to small teams. In Scaling Software Agility, Dean Leffingwell describes how agile methods can be applied to enterprise-class development. Part I provides an overview of the most common and effective agile methods. Part II describes seven best practices of agility that natively scale to the enterprise level. Part III describes an additional set of seven organizational capabilities that companies can master to achieve the full benefits of software agility on an enterprise scale. This book is invaluable to software developers, testers and QA personnel, managers and team leads, as well as to executives of software organizations whose objective is to increase the quality and productivity of the software development process but who are faced with all the challenges of developing software on an enterprise scale.

Systems, Software and Services Process Improvement

Author : Rory V. Connor
Publisher : Springer
ISBN 13 : 3642222064
Total Pages : 322 pages
Book Rating : 4.6/5 (422 download)

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Book Synopsis Systems, Software and Services Process Improvement by : Rory V. Connor

Download or read book Systems, Software and Services Process Improvement written by Rory V. Connor and published by Springer. This book was released on 2011-06-24 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume constitutes the refereed proceedings of the 18th EuroSPI conference, held in Roskilde, Denmark, in June 2011. The 18 revised full papers presented together with 9 key notes were carefully reviewed and selected. They are organized in topical sections on SPI and assessments; SPI and implementation; SPI and improvement methods; SPI organization; SPI people/ teams; SPI and reuse; selected key notes for SPI implementation.

Software Process Improvement and Capability Determination

Author : Antanas Mitasiunas
Publisher : Springer
ISBN 13 : 3319130366
Total Pages : 294 pages
Book Rating : 4.3/5 (191 download)

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Book Synopsis Software Process Improvement and Capability Determination by : Antanas Mitasiunas

Download or read book Software Process Improvement and Capability Determination written by Antanas Mitasiunas and published by Springer. This book was released on 2014-10-13 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed proceedings of the 14th International Conference on Software Process Improvement and Capability Determination, SPICE 2014, held in Vilnius, Lithuania, in November 2014. The 21 revised full papers presented together with 6 short papers were carefully reviewed and selected from 49 submissions. The papers are organized in topical sections on developing process models for assessment; software process and models; software models and product lines; assessment; agile processes; processes improvement and VSE.

Systems, Software and Services Process Improvement

Author : Christian Kreiner
Publisher : Springer
ISBN 13 : 331944817X
Total Pages : 348 pages
Book Rating : 4.3/5 (194 download)

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Book Synopsis Systems, Software and Services Process Improvement by : Christian Kreiner

Download or read book Systems, Software and Services Process Improvement written by Christian Kreiner and published by Springer. This book was released on 2016-08-31 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume constitutes the refereed proceedings of the 23rd EuroSPI conference, held in Graz, Austria, in September 2016.The 15 revised full papers presented together with 14 selected key notes and workshop papers were carefully reviewed and selected from 51 submissions. They are organized in topical sections on SPI and the ISO/IEC 29110 standard; communication and team issues in SPI; SPI and assessment; SPI in secure and safety critical environments; SPI initiatives; GamifySPI; functional safety; supporting innovation and improvement.

Systems, Software and Services Process Improvement

Author : Béatrix Barafort
Publisher : Springer
ISBN 13 : 3662438968
Total Pages : 348 pages
Book Rating : 4.6/5 (624 download)

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Book Synopsis Systems, Software and Services Process Improvement by : Béatrix Barafort

Download or read book Systems, Software and Services Process Improvement written by Béatrix Barafort and published by Springer. This book was released on 2014-06-12 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume constitutes the refereed proceedings of the 21st EuroSPI conference, held in Luxembourg, in June 2014. The 18 revised papers presented together with 11 invited papers in this volume were carefully reviewed and selected. They are organized in topical sections on SPI and very small entities; process improvement frameworks; testing and improvement issues; SPI and people issues; SPI and quality issues; software processes in various contexts. The volume also contains selected keynote papers from EuroSPI workshops and invited papers covering the topic of creating environments supporting innovation and improvement.

Introduction to Medical Software

Author : Xenophon Papademetris
Publisher : Cambridge University Press
ISBN 13 : 1009090143
Total Pages : 342 pages
Book Rating : 4.0/5 (9 download)

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Book Synopsis Introduction to Medical Software by : Xenophon Papademetris

Download or read book Introduction to Medical Software written by Xenophon Papademetris and published by Cambridge University Press. This book was released on 2022-05-05 with total page 342 pages. Available in PDF, EPUB and Kindle. Book excerpt: Providing a concise and accessible overview of the design, implementation and management of medical software, this textbook will equip students with a solid understanding of critical considerations for both standalone medical software (software as a medical device/SaMD) and software that is integrated into hardware devices. It includes: practical discussion of key regulatory documents and industry standards, and how these translate into concrete considerations for medical software design; detailed coverage of the medical software lifecycle process ; accessible introduction to quality and risk management systems in the context of medical software; succinct coverage of essential topics in data science, machine learning, statistics, cybersecurity, software engineering and healthcare bring readers up-to-speed; six cautionary real-world case studies illustrate the dangers of improper or careless software processes. Accompanied by online resources for instructors, this is the ideal introduction for undergraduate students in biomedical engineering, electrical engineering and computer science, junior software engineers, and digital health entrepreneurs.

Medical Device Regulatory Practices

Author : Val Theisz
Publisher : CRC Press
ISBN 13 : 9814669113
Total Pages : 578 pages
Book Rating : 4.8/5 (146 download)

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Book Synopsis Medical Device Regulatory Practices by : Val Theisz

Download or read book Medical Device Regulatory Practices written by Val Theisz and published by CRC Press. This book was released on 2015-08-03 with total page 578 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effectiv

Systems, Software and Services Process Improvement

Author : Murat Yilmaz
Publisher : Springer Nature
ISBN 13 : 3031711394
Total Pages : 469 pages
Book Rating : 4.0/5 (317 download)

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Book Synopsis Systems, Software and Services Process Improvement by : Murat Yilmaz

Download or read book Systems, Software and Services Process Improvement written by Murat Yilmaz and published by Springer Nature. This book was released on with total page 469 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Software Technology

Author : Mike Hinchey
Publisher : John Wiley & Sons
ISBN 13 : 1119174236
Total Pages : 338 pages
Book Rating : 4.1/5 (191 download)

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Book Synopsis Software Technology by : Mike Hinchey

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.

Software and Data Technologies

Author : Joaquim Filipe
Publisher : Springer Science & Business Media
ISBN 13 : 3540706216
Total Pages : 390 pages
Book Rating : 4.5/5 (47 download)

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Book Synopsis Software and Data Technologies by : Joaquim Filipe

Download or read book Software and Data Technologies written by Joaquim Filipe and published by Springer Science & Business Media. This book was released on 2008-07-18 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book contains the best papers of the First International Conference on Software and Data Technologies (ICSOFT 2006), organized by the Institute for Systems and Technologies of Information, Communication and Control (INSTICC) in cooperation with the Object Management Group (OMG). Hosted by the School of Business of the Polytechnic Institute of Setubal, the conference was sponsored by Enterprise Ireland and the Polytechnic Institute of Setúbal. The purpose of ICSOFT 2006 was to bring together researchers and practitioners int- ested in information technology and software development. The conference tracks were “Software Engineering”, “Information Systems and Data Management”, “Programming Languages”, “Distributed and Parallel Systems” and “Knowledge Engineering.” Being crucial for the development of information systems, software and data te- nologies encompass a large number of research topics and applications: from imp- mentation-related issues to more abstract theoretical aspects of software engineering; from databases and data-warehouses to management information systems and kno- edge-base systems; next to that, distributed systems, pervasive computing, data quality and other related topics are included in the scope of this conference. ICSOFT included in its program a panel to discuss the future of software devel- ment, composed by six distinguished world-class researchers. Furthermore, the c- ference program was enriched by a tutorial and six keynote lectures. ICSOFT 2006 received 187 paper submissions from 39 countries in all continents.