Medical Device Software Verification Validation And Compliance
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Medical Device Software Verification Validation And Compliance
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Author : David A. Vogel
language : en
Publisher: Artech House
Release Date : 2011
Medical Device Software Verification Validation And Compliance written by David A. Vogel and has been published by Artech House this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011 with Medical categories.
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."
Writing In House Medical Device Software In Compliance With Eu Uk And Us Regulations
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Author : Philip S. Cosgriff
language : en
Publisher: CRC Press
Release Date : 2024-03-26
Writing In House Medical Device Software In Compliance With Eu Uk And Us Regulations written by Philip S. Cosgriff and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-03-26 with Medical categories.
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
Software Process Improvement And Capability Determination
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Author : Antanas Mitasiunas
language : en
Publisher: Springer
Release Date : 2014-10-13
Software Process Improvement And Capability Determination written by Antanas Mitasiunas and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-10-13 with Business & Economics categories.
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.
Software Process Improvement And Capability Determination
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Author : Tanja Woronowicz
language : en
Publisher: Springer
Release Date : 2013-05-21
Software Process Improvement And Capability Determination written by Tanja Woronowicz and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-05-21 with Business & Economics categories.
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.
Introduction To Medical Software
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Author : Xenophon Papademetris
language : en
Publisher: Cambridge University Press
Release Date : 2022-05-05
Introduction To Medical Software written by Xenophon Papademetris and has been published by Cambridge University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-05-05 with Business & Economics categories.
A concise and accessible overview of the design, implementation and management of medical software.
Product Focused Software Process Improvement
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Author : Andreas Jedlitschka
language : en
Publisher: Springer
Release Date : 2014-11-13
Product Focused Software Process Improvement written by Andreas Jedlitschka and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-11-13 with Computers categories.
This book constitutes the refereed proceedings of the 15th International Conference on Product-Focused Software Process Improvement, PROFES 2014, held in Helsinki, Finland, in December 2014. The 18 revised full papers presented together with 14 short papers were carefully reviewed and selected from 45 initial submissions. The papers are organized in topical sections on agile development, decision-making, development practices and issues, product planning, and project management.
Secure And Smart Cyber Physical Systems
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Author : Uttam Ghosh
language : en
Publisher: CRC Press
Release Date : 2024-07-26
Secure And Smart Cyber Physical Systems written by Uttam Ghosh and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-07-26 with Computers categories.
Cybersecurity is a paramount concern in both Internet of Things (IoT) and Cyber-Physical Systems (CPSs) due to the interconnected and often critical nature of these systems. The integration of AI/ML into the realm of IoT and CPS security has gained significant attention and momentum in recent years. The success of AI/ML in various domains has sparked interest in leveraging these technologies to enhance the security, resilience, and adaptability of IoT and CPS. Secure and Smart Cyber-Physical Systems provides an extensive exploration of AI/ML-based security applications in the context of IoT and CPS. Features Presents cutting-edge topics and research in IoT and CPS Includes contributions from leading worldwide researchers Focuses on CPS architectures for secure and smart environments Explores AI/ML and blockchain approaches for providing security and privacy to CPS including smart grids, smart cities, and smart healthcare Provides comprehensive guidance into the intricate world of software development for medical devices Covers a blueprint for the emergence of 6G communications technology in Industry 5.0 and federated-learning-based secure financial services This book covers state-of-the-art problems, existing solutions, and potential research directions for CPS researchers, scholars, and professionals in both industry and academia.
Structured Object Oriented Formal Language And Method
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Author : Shaoying Liu
language : en
Publisher: Springer
Release Date : 2013-08-04
Structured Object Oriented Formal Language And Method written by Shaoying Liu and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-08-04 with Computers categories.
This book constitutes the thoroughly refereed post-conference proceedings of the Second International Workshop on Structured Object-Oriented Formal Language, SOFL 2012, held in Kyoto, Japan, in November 2012. The 10 full papers presented were carefully reviewed and selected for inclusion in this book and address the following topics of interest: testing and tools; tools for specification; model checking; and application and prototyping.
The Practice Of Formal Methods
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Author : Ana Cavalcanti
language : en
Publisher: Springer Nature
Release Date : 2024-09-03
The Practice Of Formal Methods written by Ana Cavalcanti and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-09-03 with Computers categories.
This Festschrift, dedicated to Cliff Jones, contains papers written by many of his closest collaborators. Cliff has an exceptional international standing for his groundbreaking research and leadership within the practice of formal methods, his career encompasses significant contributions to academia, industry, policy, and service. Cliff is a Fellow of the Royal Academy of Engineering, ACM, BCS, and IET, and in 2015 he was the inaugural Fellow of the Formal Methods Europe association. His career has included industry research in the UK, Austria and Belgium, a PhD at the University of Oxford, and academic and research roles at the University of Cambridge and the University of Manchester, and since 1999 at Newcastle University. Throughout his career, he has championed the essential role of formalism in design processes. His collaboration at IBM in the 1970s led to the creation of the Vienna Development Method (VDM), a seminal contribution that has influenced both practical industry applications and theoretical advancements. Cliff was the founding editor of the ACM journal Formal Aspects of Computing, a founder of the Formal Methods symposium, and he played a pivotal role in the IFIP Working Groups on Programming Methodology and Verified Software. His policy advocacy has been instrumental in fostering public discourse on the reliability of computing systems. The 30 contributions in this volume are a snapshot of the many current scientific developments inspired by or built upon Cliff’s contributions.
Validation Compliance Annual
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Author : International Validation Forum
language : en
Publisher: CRC Press
Release Date : 2024-11-15
Validation Compliance Annual written by International Validation Forum and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-11-15 with Science categories.
"Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."