Mastering Safety Risk Management for Medical and In Vitro Devices


Book Description

When it comes to medical and in vitro devices, risk management starts with a design assurance process that helps practitioners identify, understand, analyze, and mitigate the risks of the healthcare product design for favorable benefit-risk assessment. Risk management actively follows the product’s life cycle into production and post-market phases. This book offers a blueprint for implementing an effective risk management system. It provides risk management tools and a compliance framework for methods in conformance to ISO 13485:2016, ISO 14971:2019, European Union MDR, IVDR, and US FDA regulations (including the new FDA QMSR).




Nanotechnology: Concepts, Methodologies, Tools, and Applications


Book Description

Over the past few decades, devices and technologies have been significantly miniaturized from one generation to the next, providing far more potential in a much smaller package. The smallest of these recently developed tools are miniscule enough to be invisible to the naked eye. Nanotechnology: Concepts, Methodologies, Tools, and Applications describes some of the latest advances in microscopic technologies in fields as diverse as biochemistry, materials science, medicine, and electronics. Through its investigation of theories, applications, and new developments in the nanotechnology field, this impressive reference source will serve as a valuable tool for researchers, engineers, academics, and students alike.




Design and Test Technology for Dependable Systems-on-chip


Book Description

"This book covers aspects of system design and efficient modelling, and also introduces various fault models and fault mechanisms associated with digital circuits integrated into System on Chip (SoC), Multi-Processor System-on Chip (MPSoC) or Network on Chip (NoC)"--




Advances in Computers


Book Description

Advances in Computers, Volume 107, the latest volume in a series published since 1960, presents detailed coverage of innovations in computer hardware, software, theory, design and applications. Chapters in this updated volume include Advances in Model-based Analysis and Testing, Advances in Software Quality Assurance, Advances in Handling Uncertainty in Testing, Advances in Testing of Communicating Systems, and Advances in Formal Verification and Cyber-physical Systems. This book provides contributors with a medium in which they can explore their subjects in greater depth and breadth than journal articles usually allow. Provides in-depth surveys and tutorials on new computer technology Presents well-known authors and researchers in the field Includes extensive bibliographies with most chapters Volumes are devoted to single themes or subfields of computer science




Systems, Software and Services Process Improvement


Book Description

This volume constitutes the refereed proceedings of the 19th EuroSPI conference, held in Vienna, Austria, in June 2012. The 29 revised papers presented in this volume were carefully reviewed and selected. They are organized in topical sections on SPI and business factors; SPI lifecycle and models; SPI assessment and quality; SPI processes and standards; SPI in SMEs; SPI and implementation; creating environments supporting innovation and improvement; standards and experiences with the implementation of functional safety; business process management; SPI in SMEs - a project management perspective.







Proceedings of Data Analytics and Management


Book Description

This book includes original unpublished contributions presented at the International Conference on Data Analytics and Management (ICDAM 2023), held at London Metropolitan University, London, UK, during June 2023. The book covers the topics in data analytics, data management, big data, computational intelligence, and communication networks. The book presents innovative work by leading academics, researchers, and experts from industry which is useful for young researchers and students. The book is divided into four volumes.