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Author : Gerardus Blokdyk
Publisher :
ISBN 13 : 9780655981114
Total Pages : 0 pages
Book Rating : 4.9/5 (811 download)
Download or read book IEC 62304 A Complete Guide - 2020 Edition written by Gerardus Blokdyk and published by . This book was released on 2019 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: IEC 62304 A Complete Guide - 2020 Edition.
Author : Gerardus Blokdyk
Publisher : 5starcooks
ISBN 13 : 9780655931119
Total Pages : 314 pages
Book Rating : 4.9/5 (311 download)
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.
Author : Bijan Elahi
Publisher : Academic Press
ISBN 13 : 0323918239
Total Pages : 541 pages
Book Rating : 4.3/5 (239 download)
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
Author : David A. Vogel
Publisher : Artech House
ISBN 13 : 1596934239
Total Pages : 445 pages
Book Rating : 4.5/5 (969 download)
Download or read book Medical Device Software Verification, Validation and Compliance written by David A. Vogel and published by Artech House. This book was released on 2011 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Susan Neadle
Publisher : CRC Press
ISBN 13 : 1000874583
Total Pages : 439 pages
Book Rating : 4.0/5 (8 download)
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.
Author : Philip S. Cosgriff
Publisher : CRC Press
ISBN 13 : 1040002358
Total Pages : 223 pages
Book Rating : 4.0/5 (4 download)
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
Author : INCOSE
Publisher : John Wiley & Sons
ISBN 13 : 1119814316
Total Pages : 374 pages
Book Rating : 4.1/5 (198 download)
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.
Author : Jayet Moon
Publisher : Quality Press
ISBN 13 : 1636941729
Total Pages : 195 pages
Book Rating : 4.6/5 (369 download)
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).
Author : Murat Yilmaz
Publisher : Springer Nature
ISBN 13 : 3031711394
Total Pages : 469 pages
Book Rating : 4.0/5 (317 download)
Download or read book Systems, Software and Services Process Improvement written by Murat Yilmaz and published by Springer Nature. This book was released on with total page 469 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Chris Hobbs
Publisher : CRC Press
ISBN 13 : 1000507335
Total Pages : 308 pages
Book Rating : 4.0/5 (5 download)
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."
Author : Axel Wirth
Publisher : Artech House
ISBN 13 : 163081816X
Total Pages : 303 pages
Book Rating : 4.6/5 (38 download)
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.
Author : Paolo Gargiulo
Publisher : Elsevier
ISBN 13 : 0323910408
Total Pages : 467 pages
Book Rating : 4.3/5 (239 download)
Download or read book Handbook of Surgical Planning and 3D Printing written by Paolo Gargiulo and published by Elsevier. This book was released on 2023-03-23 with total page 467 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Surgical Planning and 3D Printing: Applications, Integration, and New Directions?covers 3D printing and surgical planning from clinical, technical and economic points-of-view. This book fills knowledge gaps by addressing: (1) What type of medical images are needed for 3D printing, and for which specific application? (2) What software should be used to process the images, should the software be considered a medical device? (3) Data protection? (4) What are the possible clinical applications and differences in imaging, segmentation, and 3D printing? And finally, (5) What skills, resources, and organization are needed? Sections cover technologies involved in 3D printing in health: data structure, medical images and segmentation, printing materials and 3d printing, 3D printing and Clinical Applications: orthopedic surgery, neurosurgery, maxillofacial, orthodontistry, surgical guides, integrating 3D printing Service in Hospitals: infrastructures, competences, organization and cost/benefits, and more. - Provides a unique insight into a technological process and its applications - Heps readers find answers to practical and technical questions concerning 3D printing and surgical planning - Presents deep insights into new directions of 3D printing in healthcare and related emerging applications such as bioprinting, biocompatible materials and metal printing for custom-made prosthetic design
Author : Frank Brill
Publisher : Academic Press
ISBN 13 : 0128166193
Total Pages : 374 pages
Book Rating : 4.1/5 (281 download)
Download or read book OpenVX Programming Guide written by Frank Brill and published by Academic Press. This book was released on 2020-05-22 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: OpenVX is the computer vision API adopted by many high-performance processor vendors. It is quickly becoming the preferred way to write fast and power-efficient code on embedded systems. OpenVX Programming Guidebook presents definitive information on OpenVX 1.2 and 1.3, the Neural Network, and other extensions as well as the OpenVX Safety Critical standard. This book gives a high-level overview of the OpenVX standard, its design principles, and overall structure. It covers computer vision functions and the graph API, providing examples of usage for the majority of the functions. It is intended both for the first-time user of OpenVX and as a reference for experienced OpenVX developers. - Get to grips with the OpenVX standard and gain insight why various options were chosen - Start developing efficient OpenVX code instantly - Understand design principles and use them to create robust code - Develop consumer and industrial products that use computer vision to understand and interact with the real world
Author : David J. Reinkensmeyer
Publisher : Springer
ISBN 13 : 331928603X
Total Pages : 647 pages
Book Rating : 4.3/5 (192 download)
Download or read book Neurorehabilitation Technology written by David J. Reinkensmeyer and published by Springer. This book was released on 2016-08-03 with total page 647 pages. Available in PDF, EPUB and Kindle. Book excerpt: This revised, updated second edition provides an accessible, practical overview of major areas of technical development and clinical application in the field of neurorehabilitation movement therapy. The initial section provides a rationale for technology application in movement therapy by summarizing recent findings in neuroplasticity and motor learning. The following section then explains the state of the art in human-machine interaction requirements for clinical rehabilitation practice. Subsequent sections describe the ongoing revolution in robotic therapy for upper extremity movement and for walking, and then describe other emerging technologies including electrical stimulation, virtual reality, wearable sensors, and brain-computer interfaces. The promises and limitations of these technologies in neurorehabilitation are discussed. Throughout the book the chapters provide detailed practical information on state-of-the-art clinical applications of these devices following stroke, spinal cord injury, and other neurologic disorders. The text is illustrated throughout with photographs and schematic diagrams which serve to clarify the information for the reader. Neurorehabilitation Technology, Second Edition is a valuable resource for neurologists, biomedical engineers, roboticists, rehabilitation specialists, physiotherapists, occupational therapists and those training in these fields.
Author : Xabier Larrucea
Publisher : Springer
ISBN 13 : 3319979256
Total Pages : 665 pages
Book Rating : 4.3/5 (199 download)
Download or read book Systems, Software and Services Process Improvement written by Xabier Larrucea and published by Springer. This book was released on 2018-08-22 with total page 665 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume constitutes the refereed proceedings of the 25th European Conference on Systems, Software and Services Process Improvement, EuroSPI conference, held in Bilbao, Spain, in September 2018. The 56 revised full papers presented were carefully reviewed and selected from 95 submissions. They are organized in topical sections on SPI context and agility, SPI and safety testing, SPI and management issues, SPI and assessment, SPI and safety critical, gamifySPI, SPI in industry 4.0, best practices in implementing traceability, good and bad practices in improvement, safety and security, experiences with agile and lean, standards and assessment models,team skills and diversity strategies, SPI in medical device industry, empowering the future infrastructure.
Author : Michael Mahler
Publisher : Academic Press
ISBN 13 : 032385432X
Total Pages : 302 pages
Book Rating : 4.3/5 (238 download)
Download or read book Precision Medicine and Artificial Intelligence written by Michael Mahler and published by Academic Press. This book was released on 2021-03-12 with total page 302 pages. Available in PDF, EPUB and Kindle. Book excerpt: Precision Medicine and Artificial Intelligence: The Perfect Fit for Autoimmunity covers background on artificial intelligence (AI), its link to precision medicine (PM), and examples of AI in healthcare, especially autoimmunity. The book highlights future perspectives and potential directions as AI has gained significant attention during the past decade. Autoimmune diseases are complex and heterogeneous conditions, but exciting new developments and implementation tactics surrounding automated systems have enabled the generation of large datasets, making autoimmunity an ideal target for AI and precision medicine. More and more diagnostic products utilize AI, which is also starting to be supported by regulatory agencies such as the Food and Drug Administration (FDA). Knowledge generation by leveraging large datasets including demographic, environmental, clinical and biomarker data has the potential to not only impact the diagnosis of patients, but also disease prediction, prognosis and treatment options. - Allows the readers to gain an overview on precision medicine for autoimmune diseases leveraging AI solutions - Provides background, milestone and examples of precision medicine - Outlines the paradigm shift towards precision medicine driven by value-based systems - Discusses future applications of precision medicine research using AI - Other aspects covered in the book include regulatory insights, data analytics and visualization, types of biomarkers as well as the role of the patient in precision medicine
Author : Xenophon Papademetris
Publisher : Cambridge University Press
ISBN 13 : 1316514994
Total Pages : 341 pages
Book Rating : 4.3/5 (165 download)
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.
