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Iec 62304 A Complete Guide 2019 Edition
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Book Synopsis MEDINFO 2019: Health and Wellbeing e-Networks for All by : L. Ohno-Machado
Download or read book MEDINFO 2019: Health and Wellbeing e-Networks for All written by L. Ohno-Machado and published by IOS Press. This book was released on 2019-11-12 with total page 2078 pages. Available in PDF, EPUB and Kindle. Book excerpt: Combining and integrating cross-institutional data remains a challenge for both researchers and those involved in patient care. Patient-generated data can contribute precious information to healthcare professionals by enabling monitoring under normal life conditions and also helping patients play a more active role in their own care. This book presents the proceedings of MEDINFO 2019, the 17th World Congress on Medical and Health Informatics, held in Lyon, France, from 25 to 30 August 2019. The theme of this year’s conference was ‘Health and Wellbeing: E-Networks for All’, stressing the increasing importance of networks in healthcare on the one hand, and the patient-centered perspective on the other. Over 1100 manuscripts were submitted to the conference and, after a thorough review process by at least three reviewers and assessment by a scientific program committee member, 285 papers and 296 posters were accepted, together with 47 podium abstracts, 7 demonstrations, 45 panels, 21 workshops and 9 tutorials. All accepted paper and poster contributions are included in these proceedings. The papers are grouped under four thematic tracks: interpreting health and biomedical data, supporting care delivery, enabling precision medicine and public health, and the human element in medical informatics. The posters are divided into the same four groups. The book presents an overview of state-of-the-art informatics projects from multiple regions of the world; it will be of interest to anyone working in the field of medical informatics.
Book Synopsis INCOSE Systems Engineering Handbook by : INCOSE
Download or read book INCOSE Systems Engineering Handbook written by INCOSE and published by John Wiley & Sons. This book was released on 2023-06-08 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: SYSTEMS ENGINEERING HANDBOOK A comprehensive reference on the discipline and practice of systems engineering Systems engineering practitioners provide a wide range of vital functions, conceiving, developing, and supporting complex engineered systems with many interacting elements. The International Council on Systems Engineering (INCOSE) Systems Engineering Handbook describes the state-of-the-good-practice of systems engineering. The result is a comprehensive guide to systems engineering activities across any number of possible projects. From automotive to defense to healthcare to infrastructure, systems engineering practitioners are at the heart of any project built on complex systems. INCOSE Systems Engineering Handbook readers will find: Elaboration on the key systems life cycle processes described in ISO/IEC/IEEE 15288:2023; Chapters covering key systems engineering concepts, system life cycle processes and methods, tailoring and application considerations, systems engineering in practice, and more; and Appendices, including an N2 diagram of the systems engineering processes and a detailed topical index. The INCOSE Systems Engineering Handbook is a vital reference for systems engineering practitioners and engineers in other disciplines looking to perform or understand the discipline of systems engineering.
Book Synopsis Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations by : Philip S. Cosgriff
Download or read book Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations written by Philip S. Cosgriff and published by CRC Press. This book was released on 2024-03-26 with total page 223 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Safety Risk Management for Medical Devices by : Bijan Elahi
Download or read book Safety Risk Management for Medical Devices written by Bijan Elahi and published by Academic Press. This book was released on 2021-11-11 with total page 541 pages. Available in PDF, EPUB and Kindle. Book excerpt: Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs. Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations. - Includes new coverage of ISO 14971:2019, ISO/TR 24971 - Presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk management - Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation
Book Synopsis IEC 62304 A Complete Guide - 2020 Edition by : Gerardus Blokdyk
Download or read book IEC 62304 A Complete Guide - 2020 Edition written by Gerardus Blokdyk and published by 5starcooks. This book was released on 2019-09-29 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: How do you produce usable, medical device regulated software? Does your organization have a product security function? Software cannot be released for use until validation has been completed? How frequent are computing technology-related medical device failures? Who is responsible for on-line help? This breakthrough IEC 62304 self-assessment will make you the reliable IEC 62304 domain authority by revealing just what you need to know to be fluent and ready for any IEC 62304 challenge. How do I reduce the effort in the IEC 62304 work to be done to get problems solved? How can I ensure that plans of action include every IEC 62304 task and that every IEC 62304 outcome is in place? How will I save time investigating strategic and tactical options and ensuring IEC 62304 costs are low? How can I deliver tailored IEC 62304 advice instantly with structured going-forward plans? There's no better guide through these mind-expanding questions than acclaimed best-selling author Gerard Blokdyk. Blokdyk ensures all IEC 62304 essentials are covered, from every angle: the IEC 62304 self-assessment shows succinctly and clearly that what needs to be clarified to organize the required activities and processes so that IEC 62304 outcomes are achieved. Contains extensive criteria grounded in past and current successful projects and activities by experienced IEC 62304 practitioners. Their mastery, combined with the easy elegance of the self-assessment, provides its superior value to you in knowing how to ensure the outcome of any efforts in IEC 62304 are maximized with professional results. Your purchase includes access details to the IEC 62304 self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows you exactly what to do next. Your exclusive instant access details can be found in your book. You will receive the following contents with New and Updated specific criteria: - The latest quick edition of the book in PDF - The latest complete edition of the book in PDF, which criteria correspond to the criteria in... - The Self-Assessment Excel Dashboard - Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation - In-depth and specific IEC 62304 Checklists - Project management checklists and templates to assist with implementation INCLUDES LIFETIME SELF ASSESSMENT UPDATES Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.
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 2021-08-26 with total page 753 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume constitutes the refereed proceedings of the 28th European Conference on Systems, Software and Services Process Improvement, EuroSPI 2021, held in Krems, Austria, in September 2021*. The 42 full papers and 9 short papers presented were carefully reviewed and selected from 100 submissions. The volume presents core research contributions and selected industrial contributions. Core research contributions: SPI and emerging software and systems engineering paradigms; SPI and team skills and diversity; SPI and recent innovations; SPI and agile; SPI and standards and safety and security norms; SPI and good/bad SPI practices in improvement; SPI and functional safety and cybersecurity; digitalisation of industry, infrastructure and e-mobility. Selected industrial contributions: SPI and emerging software and systems engineering paradigms; SPI and recent innovations; SPI and agile; SPI and standards and safety and security norms; SPI and good/bad SPI practices in improvement; SPI and functional safety and cybersecurity; digitalisation of industry, infrastructure and e-mobility; virtual reality. *The conference was partially held virtually due to the COVID-19 pandemic.
Book Synopsis Embedded Software Development for Safety-Critical Systems, Second Edition by : Chris Hobbs
Download or read book Embedded Software Development for Safety-Critical Systems, Second Edition written by Chris Hobbs and published by CRC Press. This book was released on 2019-08-16 with total page 308 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a book about the development of dependable, embedded software. It is for systems designers, implementers, and verifiers who are experienced in general embedded software development, but who are now facing the prospect of delivering a software-based system for a safety-critical application. It is aimed at those creating a product that must satisfy one or more of the international standards relating to safety-critical applications, including IEC 61508, ISO 26262, EN 50128, EN 50657, IEC 62304, or related standards. Of the first edition, Stephen Thomas, PE, Founder and Editor of FunctionalSafetyEngineer.com said, "I highly recommend Mr. Hobbs' book."
Book Synopsis Computer Safety, Reliability, and Security by : Jérémie Guiochet
Download or read book Computer Safety, Reliability, and Security written by Jérémie Guiochet and published by Springer Nature. This book was released on 2023-09-10 with total page 291 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed proceedings of the 42nd International Conference on Computer Safety, Reliability and Security, SAFECOMP 2023, which took place in Toulouse, France, in September 2023. The 20 full papers included in this volume were carefully reviewed and selected from 100 submissions. They were organized in topical sections as follows: Safety assurance; software testing and reliability; neural networks robustness and monitoring; model-based security and threat analysis; safety of autonomous driving; security engineering; AI safety; and neural networks and testing.
Book Synopsis The Combination Products Handbook by : Susan Neadle
Download or read book The Combination Products Handbook written by Susan Neadle and published by CRC Press. This book was released on 2023-05-16 with total page 439 pages. Available in PDF, EPUB and Kindle. Book excerpt: Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.
Book Synopsis Software Technology: Methods and Tools by : Manuel Mazzara
Download or read book Software Technology: Methods and Tools written by Manuel Mazzara and published by Springer Nature. This book was released on 2019-10-08 with total page 429 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed proceedings of the 51st International Conference on Software Technology: Methods and Tools, TOOLS 2019, held in Innopolis, Russia, in October 2019.The 19 revised full papers and 13 short papers presented in this book were carefully reviewed and selected from 62 submissions. The papers discuss all aspects of software engineering and programming languages; machine learning; internet of things; security computer architectures and robotics; and projects.
Book Synopsis Handbook on Augmenting Telehealth Services by : Sonali Vyas
Download or read book Handbook on Augmenting Telehealth Services written by Sonali Vyas and published by CRC Press. This book was released on 2024-01-26 with total page 301 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook on Augmenting Telehealth Services: Using Artificial Intelligence provides knowledge of AI-empowered telehealth systems for efficient healthcare services. The handbook discusses novel innovations in telehealth using AI techniques and also focuses on emerging tools and techniques in smart health systems. The book highlights important topics such as remote diagnosis of patients and presents e-health data management showcasing smart methods that can be used to improvise healthcare support and services. The handbook also shines a light on future trends in AI-enabled telehealth systems. Features Provides knowledge of AI-empowered telehealth systems for efficient healthcare services Discusses novel innovations in telehealth using AI techniques Covers emerging tools and techniques in smart health systems Highlights remote diagnosis of patients Focuses on e-health data management and showcases smart methods used to improvise healthcare support and services Shines a light on future trends in AI-enabled telehealth systems Every individual (patients, doctors, healthcare staff, etc.) is currently getting adapted to this new evolution of healthcare. This handbook is a must-read for students, researchers, academicians, and industry professionals working in the field of artificial intelligence and its uses in the healthcare sector.
Book Synopsis Mastering Safety Risk Management for Medical and In Vitro Devices by : Jayet Moon
Download or read book Mastering Safety Risk Management for Medical and In Vitro Devices written by Jayet Moon and published by Quality Press. This book was released on 2024-05-10 with total page 195 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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).
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 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: A concise and accessible overview of the design, implementation and management of medical software.
Book Synopsis MEDINFO 2021: One World, One Health — Global Partnership for Digital Innovation by : P. Otero
Download or read book MEDINFO 2021: One World, One Health — Global Partnership for Digital Innovation written by P. Otero and published by IOS Press. This book was released on 2022-08-05 with total page 1180 pages. Available in PDF, EPUB and Kindle. Book excerpt: The World Health Organization defines health as “a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity”, and its constitution also asserts that health for all people is “dependent on the fullest co-operation of individuals and States”. The ongoing pandemic has highlighted the power of both healthy and unhealthy information, so while healthcare and public health services have depended upon timely and accurate data and continually updated knowledge, social media has shown how unhealthy misinformation can be spread and amplified, reinforcing existing prejudices, conspiracy theories and political biases. This book presents the proceedings of MedInfo 2021, the 18th World Congress of Medical and Health Informatics, held as a virtual event from 2-4 October 2021, with pre-recorded presentations for all accepted submissions. The theme of the conference was One World, One Health – Global Partnership for Digital Innovation and submissions were requested under 5 themes: information and knowledge management; quality, safety and outcomes; health data science; human, organizational and social aspects; and global health informatics. The Programme Committee received 352 submissions from 41 countries across all IMIA regions, and 147 full papers, 60 student papers and 79 posters were accepted for presentation after review and are included in these proceedings. Providing an overview of current work in the field over a wide range of disciplines, the book will be of interest to all those whose work involves some aspect of medical or health informatics.
Book Synopsis Medical Device Cybersecurity for Engineers and Manufacturers by : Axel Wirth
Download or read book Medical Device Cybersecurity for Engineers and Manufacturers written by Axel Wirth and published by Artech House. This book was released on 2020-08-31 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cybersecurity for medical devices is no longer optional. We must not allow sensationalism or headlines to drive the discussion… Nevertheless, we must proceed with urgency. In the end, this is about preventing patient harm and preserving patient trust. A comprehensive guide to medical device secure lifecycle management, this is a book for engineers, managers, and regulatory specialists. Readers gain insight into the security aspects of every phase of the product lifecycle, including concept, design, implementation, supply chain, manufacturing, postmarket surveillance, maintenance, updates, and end of life. Learn how to mitigate or completely avoid common cybersecurity vulnerabilities introduced during development and production. Grow your awareness of cybersecurity development topics ranging from high-level concepts to practical solutions and tools. Get insight into emerging regulatory and customer expectations. Uncover how to minimize schedule impacts and accelerate time-to-market while still accomplishing the main goal: reducing patient and business exposure to cybersecurity risks. Medical Device Cybersecurity for Engineers and Manufacturers is designed to help all stakeholders lead the charge to a better medical device security posture and improve the resilience of our medical device ecosystem.
Book Synopsis Medical-Grade Software Development by : Ilkka Juuso
Download or read book Medical-Grade Software Development written by Ilkka Juuso and published by CRC Press. This book was released on 2023-11-13 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a practical guide to meeting IEC 62304 software-development requirements within the context of an ISO 13485 quality management system (QMS). The book proves this can be done with a minimum amount of friction, overlap, and back-and-forth between development stages. It essentially shows you how you should shape your medical-software development processes to fit in with the QMS processes in the smartest and leanest way possible. By following the advice in this book, you can reuse processes from your QMS, ensure your product-realization processes meet the requirements for medical-software development, and marry all the requirements together using tried and tested solutions into one efficient system. The expertise of the authors here goes beyond just the experiences of one real-world project as they tap into over 30 years of experience and countless software and software-assessment projects to distill their advice. The book takes a hands-on approach by first teaching you the top 25 lessons to know before starting to develop a process for medical-software development. It then walks you through the expectations placed on the key aspects of such a process by the key standards. The book progresses from an overview of both standards and the general requirements involved to a detailed discussion of the expected stages from software development and maintenance to risk management, configuration management, and problem resolution. The book provides insightful advice on how the requirements of the IEC 62304 software-development life cycle can be married with an ISO 13485 QMS, how the development of the technical file should be organized, and how to address conformity assessment, the daily after-approval, and the recent trends that will affect the industry in the coming years. The book is modeled after the IEC 62304 standard and adopts its clause structure in the numbering of sections for easy reference. The book does not attempt to replicate either standard. For the ISO 13485 standard, it recites the necessary requirements succinctly. For IEC 62304, the discussion is in-depth and also addresses the impact of ISO 13485 on the requirements discussed. In this way, the book drills into both standards to expose the core of each requirement and shape these into a practical, cohesive workflow for developing, maintaining, and improving a Lean software development pipeline.
Book Synopsis Orthopaedic Technology Innovation: A Step-by-Step Guide from Concept to Commercialization by : Adam Eltorai
Download or read book Orthopaedic Technology Innovation: A Step-by-Step Guide from Concept to Commercialization written by Adam Eltorai and published by Lippincott Williams & Wilkins. This book was released on 2019-10-08 with total page 293 pages. Available in PDF, EPUB and Kindle. Book excerpt: Have an idea for a new tool or instrument? This a great resource to use to bring your invention ideas to the bedside! Written for clinicians, researchers, students, and entrepreneurs, this concise yet comprehensive review presents a clear process to identify, invent, and implement new technology solutions that aid in effective and safe practice in orthopedic surgery.
