Medical Device Software Verification, Validation and Compliance PDF Download
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Author: David A. Vogel
Publisher: Artech House
ISBN: 1596934239
Category : Medical
Languages : en
Pages : 445
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Book Description
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."
Author: David A. Vogel
Publisher: Artech House
ISBN: 1596934239
Category : Medical
Languages : en
Pages : 445
Get Book Here
Book Description
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."
Author: Philip S. Cosgriff
Publisher: CRC Press
ISBN: 1040002358
Category : Science
Languages : en
Pages : 223
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Book Description
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
Author: Antanas Mitasiunas
Publisher: Springer
ISBN: 3319130366
Category : Business & Economics
Languages : en
Pages : 294
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Book Description
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.
Author: Tanja Woronowicz
Publisher: Springer
ISBN: 3642388337
Category : Business & Economics
Languages : en
Pages : 278
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Book Description
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.
Author: Xenophon Papademetris
Publisher: Cambridge University Press
ISBN: 1316514994
Category : Business & Economics
Languages : en
Pages : 341
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Book Description
A concise and accessible overview of the design, implementation and management of medical software.
Author: Andreas Jedlitschka
Publisher: Springer
ISBN: 3319138359
Category : Computers
Languages : en
Pages : 340
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Book Description
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.
Author: Uttam Ghosh
Publisher: CRC Press
ISBN: 1040012558
Category : Computers
Languages : en
Pages : 260
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Book Description
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.
Author: Shaoying Liu
Publisher: Springer
ISBN: 3642392776
Category : Computers
Languages : en
Pages : 156
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Book Description
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.
Author: Ana Cavalcanti
Publisher: Springer Nature
ISBN: 3031666763
Category :
Languages : en
Pages : 337
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Book Description
Author: Haider Raad
Publisher: John Wiley & Sons
ISBN: 1119617553
Category : Technology & Engineering
Languages : en
Pages : 304
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Book Description
Explore this indispensable guide covering the fundamentals of IOT and wearable devices from a leading voice in the field Fundamentals of IoT and Wearable Technology Design delivers a comprehensive exploration of the foundations of the Internet of Things (IoT) and wearable technology. Throughout the textbook, the focus is on IoT and wearable technology and their applications, including mobile health, environment, home automation, and smart living. Readers will learn about the most recent developments in the design and prototyping of these devices. This interdisciplinary work combines technical concepts from electrical, mechanical, biomedical, computer, and industrial engineering, all of which are used in the design and manufacture of IoT and wearable devices. Fundamentals of IoT and Wearable Technology Design thoroughly investigates the foundational characteristics, architectural aspects, and practical considerations, while offering readers detailed and systematic design and prototyping processes of typical use cases representing IoT and wearable technology. Later chapters discuss crucial issues, including PCB design, cloud and edge topologies, privacy and health concerns, and regulatory policies. Readers will also benefit from the inclusion of: A thorough introduction to the applications of IoT and wearable technology, including biomedicine and healthcare, fitness and wellbeing, sports, home automation, and more Discussions of wearable components and technologies, including microcontrollers and microprocessors, sensors, actuators and communication modules An exploration of the characteristics and basics of the communication protocols and technologies used in IoT and wearable devices An overview of the most important security challenges, threats, attacks and vulnerabilities faced by IoT and wearable devices along with potential solutions Perfect for research and development scientists working in the wearable technology and Internet of Things spaces, Fundamentals of IoT and Wearable Technology Design will also earn a place in the libraries of undergraduate and graduate students studying wearable technology and IoT, as well as professors and practicing technologists in the area.
