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This updatable reference work gives a comprehensive overview of all relevant regulatory information and requirements for manufacturers and distributors around medical and in-vitro diagnostic devices in Europe. These individual requirements are presented in a practice-oriented manner, providing the reader with a concrete guide to implementation with main focus on the EU medical device regulations, such as MDR 2017/745 and IVD-R 2017/746, and the relevant standards, such as the ISO 13485, ISO 14971, among others. This book offers a good balance of expert knowledge, empirical values and practice-proven methods. Not only it provides readers with a quick overview about the most important requirements in the medical device sector, yet it shows concrete and proven ways in which these requirements can be implemented in practice. It addresses medical manufacturing companies, professionals in development, production, and quality assurance departments, and technical and medical students who are preparing themselves for a professional career in the medical technlogy industries. .
Biomedical engineering. --- Industrial Management. --- Technological innovations. --- Biomedical Devices and Instrumentation. --- Innovation and Technology Management. --- Breakthroughs, Technological --- Innovations, Industrial --- Innovations, Technological --- Technical innovations --- Technological breakthroughs --- Technological change --- Creative ability in technology --- Inventions --- Domestication of technology --- Innovation relay centers --- Research, Industrial --- Technology transfer --- Business administration --- Business enterprises --- Business management --- Corporate management --- Corporations --- Industrial administration --- Management, Industrial --- Rationalization of industry --- Scientific management --- Management --- Business --- Industrial organization --- Clinical engineering --- Medical engineering --- Bioengineering --- Biophysics --- Engineering --- Medicine
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This book elucidates how genetic, biological and medical information can be applied to the development of personalized healthcare, medication and therapies. Focusing on aspects of the development of evidence-based approaches in bioinformatics and computational medicine, including data integration, methodologies, tools and models for clinical and translational medicine, it offers an essential introduction to clinical bioinformatics for clinical researchers and physicians, medical students and teachers, and scientists working with human disease-based omics and bioinformatics. Dr. Xiangdong Wang is a distinguished Professor of Medicine. He is Director of Shanghai Institute of Clinical Bioinformatics, Director of Fudan University Center for Clinical Bioinformatics, Deputy Director of Shanghai Respiratory Research Institute, Director of Biomedical Research Center, Fudan University Zhongshan Hospital, Shanghai, China; Dr. Christian Baumgartner is a Professor of Health Care and Biomedical Engineering at Institute of Health Care Engineering with European Notified Body of Medical Devices, Graz University of Technology, Graz, Austria; Dr. Denis Shields is a Professor of Clinical Bioinformatics at Conway Institute, Belfield, Dublin, Ireland; Dr. Hong-Wen Deng is a Professor at Department of Biostatistics and Bioinformatics, Tulane University School of Public Health and Tropical Medicine, USA; Dr. Jacques S Beckmann is a Professor and Director of Section of Clinical Bioinformatics, Swiss Institute of Bioinformatics, Switzerland.
Medicine. --- Health informatics. --- Bioinformatics. --- Biomedicine. --- Biomedicine general. --- Health Informatics. --- Medical informatics. --- Clinical informatics --- Health informatics --- Medical information science --- Clinical sciences --- Medical profession --- Bio-informatics --- Biological informatics --- Human biology --- Life sciences --- Medical sciences --- Pathology --- Physicians --- Biology --- Information science --- Computational biology --- Systems biology --- Medicine --- Data processing --- Medical records --- Data processing. --- EHR systems --- EHR technology --- EHRs (Electronic health records) --- Electronic health records --- Electronic medical records --- EMR systems --- EMRs (Electronic medical records) --- Information storage and retrieval systems --- Medical care --- Biomedicine, general. --- Health Workforce
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This book constitutes the refereed proceedings of the 5th Workshop on Uncertainty for Safe Utilization of Machine Learning in Medical Imaging, UNSURE 2023, held in conjunction with MICCAI 2023 in Vancouver, Canada, in October 2023. For this workshop, 21 papers from 32 submissions were accepted for publication. The accepted papers cover the fields of uncertainty estimation and modeling, as well as out of distribution management, domain shift robustness, Bayesian deep learning and uncertainty calibration.
Artificial intelligence. --- Image processing --- Computer vision. --- Computers. --- Application software. --- Artificial Intelligence. --- Computer Imaging, Vision, Pattern Recognition and Graphics. --- Computing Milieux. --- Computer and Information Systems Applications. --- Digital techniques.
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This book elucidates how genetic, biological and medical information can be applied to the development of personalized healthcare, medication and therapies. Focusing on aspects of the development of evidence-based approaches in bioinformatics and computational medicine, including data integration, methodologies, tools and models for clinical and translational medicine, it offers an essential introduction to clinical bioinformatics for clinical researchers and physicians, medical students and teachers, and scientists working with human disease-based omics and bioinformatics. Dr. Xiangdong Wang is a distinguished Professor of Medicine. He is Director of Shanghai Institute of Clinical Bioinformatics, Director of Fudan University Center for Clinical Bioinformatics, Deputy Director of Shanghai Respiratory Research Institute, Director of Biomedical Research Center, Fudan University Zhongshan Hospital, Shanghai, China; Dr. Christian Baumgartner is a Professor of Health Care and Biomedical Engineering at Institute of Health Care Engineering with European Notified Body of Medical Devices, Graz University of Technology, Graz, Austria; Dr. Denis Shields is a Professor of Clinical Bioinformatics at Conway Institute, Belfield, Dublin, Ireland; Dr. Hong-Wen Deng is a Professor at Department of Biostatistics and Bioinformatics, Tulane University School of Public Health and Tropical Medicine, USA; Dr. Jacques S Beckmann is a Professor and Director of Section of Clinical Bioinformatics, Swiss Institute of Bioinformatics, Switzerland.
Biomathematics. Biometry. Biostatistics --- Human biochemistry --- Pathological biochemistry --- Human medicine --- Computer. Automation --- klinische chemie --- medische biochemie --- bio-informatica --- biochemie --- biomedische wetenschappen --- medische informatica --- biometrie
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This book constitutes the refereed proceedings of the 5th Workshop on Uncertainty for Safe Utilization of Machine Learning in Medical Imaging, UNSURE 2023, held in conjunction with MICCAI 2023 in Vancouver, Canada, in October 2023. For this workshop, 21 papers from 32 submissions were accepted for publication. The accepted papers cover the fields of uncertainty estimation and modeling, as well as out of distribution management, domain shift robustness, Bayesian deep learning and uncertainty calibration.
Artificial intelligence. --- Image processing --- Computer vision. --- Computers. --- Application software. --- Artificial Intelligence. --- Computer Imaging, Vision, Pattern Recognition and Graphics. --- Computing Milieux. --- Computer and Information Systems Applications. --- Digital techniques.
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Artificial intelligence --- Diagnostic imaging --- Medical applications --- Medical applications. --- Data processing --- Medicine
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This book constitutes the refereed proceedings of the Second International Workshop on Uncertainty for Safe Utilization of Machine Learning in Medical Imaging, UNSURE 2020, and the Third International Workshop on Graphs in Biomedical Image Analysis, GRAIL 2020, held in conjunction with MICCAI 2020, in Lima, Peru, in October 2020. The workshops were held virtually due to the COVID-19 pandemic. For UNSURE 2020, 10 papers from 18 submissions were accepted for publication. They focus on developing awareness and encouraging research in the field of uncertainty modelling to enable safe implementation of machine learning tools in the clinical world. GRAIL 2020 accepted 10 papers from the 12 submissions received. The workshop aims to bring together scientists that use and develop graph-based models for the analysis of biomedical images and to encourage the exploration of graph-based models for difficult clinical problems within a variety of biomedical imaging contexts.
Mathematical statistics --- Electronics --- Telecommunication technology --- Programming --- Computer architecture. Operating systems --- Artificial intelligence. Robotics. Simulation. Graphics --- Computer. Automation --- patroonherkenning --- factoranalyse --- optische communicatie --- optische elektronica --- applicatiebeheer --- apps --- datacommunicatie --- KI (kunstmatige intelligentie) --- architectuur (informatica)
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This book constitutes the refereed proceedings of the First International Workshop on Uncertainty for Safe Utilization of Machine Learning in Medical Imaging, UNSURE 2019, and the 8th International Workshop on Clinical Image-Based Procedures, CLIP 2019, held in conjunction with MICCAI 2019, in Shenzhen, China, in October 2019. For UNSURE 2019, 8 papers from 15 submissions were accepted for publication. They focus on developing awareness and encouraging research in the field of uncertainty modelling to enable safe implementation of machine learning tools in the clinical world. CLIP 2019 accepted 11 papers from the 15 submissions received. The workshops provides a forum for work centred on specific clinical applications, including techniques and procedures based on comprehensive clinical image and other data. .
Artificial intelligence. --- Optical data processing. --- Health informatics. --- Artificial Intelligence. --- Image Processing and Computer Vision. --- Health Informatics. --- Clinical informatics --- Health informatics --- Medical information science --- Information science --- Medicine --- Optical computing --- Visual data processing --- Bionics --- Electronic data processing --- Integrated optics --- Photonics --- Computers --- AI (Artificial intelligence) --- Artificial thinking --- Electronic brains --- Intellectronics --- Intelligence, Artificial --- Intelligent machines --- Machine intelligence --- Thinking, Artificial --- Cognitive science --- Digital computer simulation --- Logic machines --- Machine theory --- Self-organizing systems --- Simulation methods --- Fifth generation computers --- Neural computers --- Data processing --- Optical equipment --- Diagnostic imaging --- Artificial intelligence --- Machine learning --- Medical applications
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Mathematical statistics --- Electronics --- Telecommunication technology --- Programming --- Computer architecture. Operating systems --- Artificial intelligence. Robotics. Simulation. Graphics --- Computer. Automation --- patroonherkenning --- factoranalyse --- optische communicatie --- optische elektronica --- applicatiebeheer --- apps --- datacommunicatie --- KI (kunstmatige intelligentie) --- architectuur (informatica)
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