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Medical Grade Software Development
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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 Integrating Device Data into the Electronic Medical Record by : John Zaleski
Download or read book Integrating Device Data into the Electronic Medical Record written by John Zaleski and published by John Wiley & Sons. This book was released on 2008-12-23 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: Future generations of vital signs and point-of-care medical devices must interoperate directly and seamlessly with information technology systems to facilitate effective patient care management within the healthcare enterprise. This is the first book addressing medical device integration with the computer-based patient record in a holistic way. Readers step into the area of two-way device communication & control and learn best practises from an author known for his brilliant expertise in this field. It is a fundamental guide for a broad group of people: clinical and biomedical engineers, physicians, bioinformatics practitioners, and vendors. Providing the essential how-to for medical device integration into the electronic medical record (EMR), health information system (HIS), and computerized patient record (CPR), the book highlights information on data extraction, usually not offered by device vendors. This comprises topics such as the use of third-party software, information on what to do when you develop interfaces on your own, regulatory issues, and how to assure connectivity and access to data. For physicians, it is a primer and knowledge manual for data integration when applied to clinical care and trials. It gives information on knowledge management and how data can be used statistically and as a tool in patient care management. Furthermore, it impresses upon the reader the quantities of data that must be processed and reduced to make for effective use at the point of care. HIS and CPR vendors may learn how data integration can be simplified and how software developers may be assisted in the process of communicating vital information to their repositories. The book is rounded off by a chapter on the future of integration.
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 Developing an ISO 13485-Certified Quality Management System by : Ilkka Juuso
Download or read book Developing an ISO 13485-Certified Quality Management System written by Ilkka Juuso and published by CRC Press. This book was released on 2022-03-20 with total page 371 pages. Available in PDF, EPUB and Kindle. Book excerpt: Developing an ISO 13485-Certified Quality Management System: An Implementation Guide for the Medical-Device Industry details the lessons learned from a real-world project focusing on building an ISO 13485:2016 Quality Management System (QMS) from scratch and then having it officially certified. It is a practical guide to building or improving your existing QMS with tried and tested solutions. The book takes a hands-on approach–first teaching the top 25 lessons to know before starting to develop a QMS and then walking you through the process of writing the quality manual and the standard operating procedures, training the staff on the QMS, organizing an internal audit, executing a management review, and finally passing the necessary external audits and obtaining certification. It helps you to progress from one task to the next and provides all the essential information to accomplish each task as quickly and efficiently as possible. It does not attempt to replicate the standard but instead drills into the standard to expose the core of each section of the standard and reorganize its contents into a practical workflow for developing, maintaining, and improving a Lean QMS. The book includes a wealth of real-world experience both from the author's personal dive into quality management, and from the experiences of other companies in the field and provides handy checklists for ensuring key documents and processes are fit for use–the emphasis here is to help ensure you have considered all relevant aspects. In addition, the book is not intended as a “cheat sheet” for the standard or as a review of the standard that only adds lengthy commentary on each of the clauses. Instead, the book fixes easy misunderstandings regarding QMS, provides insight into why the various clauses are written the way they are, and provides a great base to both understanding ISO 13485 QMS and developing your own QMS. The book is intended to serve both experts and novices audiences–it provides special insight on the most crucial and effective aspects of QMS.
Book Synopsis Developing an ISO 13485-Certified Quality Management System by : Ilkka Juuso
Download or read book Developing an ISO 13485-Certified Quality Management System written by Ilkka Juuso and published by Productivity Press. This book was released on 2022-03-21 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book details the lessons learned from a real-world project focusing on building an ISO 13485:2016 Quality Management System (QMS) from scratch and then having it officially certified. It is a practical guide to building or improving your existing QMS with tried and tested solutions.
Book Synopsis Software Engineering in Health Care by : Michaela Huhn
Download or read book Software Engineering in Health Care written by Michaela Huhn and published by Springer. This book was released on 2017-07-26 with total page 249 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes revised selected papers from the jointly held conferences FHIES 2014, 4th International Symposium on Foundations of Health Information Engineering and Systems, and SEHC 2014, 6th International Workshop on Software Engineering in Health Care. The meeting took place in Washington, DC, USA, in July 2014. The 16 papers presented in this volume were carefully reviewed and selected from 23 submissions. They deal with security aspects of health information systems; medical devices in cyberphysical systems; the process of providing healthcare and of monitoring patients; and patient safety and the assurance of medical systems.
Book Synopsis Medical Device Design by : Peter J. Ogrodnik
Download or read book Medical Device Design written by Peter J. Ogrodnik and published by Academic Press. This book was released on 2019-10-30 with total page 540 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Device Design: Innovation from Concept to Market, Second Edition provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones; this book fills that need. It addresses medical devices' regulatory (FDA and EU) requirements, shows the essential methodologies medical designers must understand to ensure their products meet requirements, and brings together proven design protocols, thus enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace. This book is unique because it takes the reader through the process of medical device development, from very early stages of conceptualization, to commercialization on the global market. This rare resource can be used by both professionals and newcomers to device design. - Provides a reference to standards and regulations that have been updated, including ISO 13485:2016, FDA regulations and the European Medical Device Regulation - Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more - Presents additional content around software and biocompatibility concerns
Book Synopsis Advances in technology for the sleep field, An Issue of Sleep Medicine Clinics, E-Book by : Steven Holfinger
Download or read book Advances in technology for the sleep field, An Issue of Sleep Medicine Clinics, E-Book written by Steven Holfinger and published by Elsevier Health Sciences. This book was released on 2023-08-03 with total page 145 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this issue of Sleep Medicine Clinics, guest editor Dr. Steven Holfinger brings his considerable expertise to the topic of Advances in Technology for the Sleep Field. Top experts discuss current development and use of multi-modal sensors and technologies which make accurate sleep monitoring at scale a possibility in today's sleep medicine. - Contains 15 practice-oriented topics including using telehealth platforms to transform sleep care models; are consumer wearable sleep trackers ready for clinical use; potential implications of screen time in an age of augmented/virtual reality; advancements in sleep health to optimize human performance; and more. - Provides in-depth clinical reviews of advances in technology for the sleep field, offering actionable insights for clinical practice. - Presents the latest information on this timely, focused topic under the leadership of experienced editors in the field. Authors synthesize and distill the latest research and practice guidelines to create clinically significant, topic-based reviews.
Download or read book Medical Device Register written by and published by . This book was released on 2007 with total page 1692 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contains a list of all manufacturers and other specified processors of medical devices registered with the Food and Drug Administration, and permitted to do business in the U.S., with addresses and telephone numbers. Organized by FDA medical device name, in alphabetical order. Keyword index to FDA established standard names of medical devices.
Book Synopsis Encyclopedia of Software Engineering Three-Volume Set (Print) by : Phillip A. Laplante
Download or read book Encyclopedia of Software Engineering Three-Volume Set (Print) written by Phillip A. Laplante and published by CRC Press. This book was released on 2010-11-22 with total page 1441 pages. Available in PDF, EPUB and Kindle. Book excerpt: Software engineering requires specialized knowledge of a broad spectrum of topics, including the construction of software and the platforms, applications, and environments in which the software operates as well as an understanding of the people who build and use the software. Offering an authoritative perspective, the two volumes of the Encyclopedia of Software Engineering cover the entire multidisciplinary scope of this important field. More than 200 expert contributors and reviewers from industry and academia across 21 countries provide easy-to-read entries that cover software requirements, design, construction, testing, maintenance, configuration management, quality control, and software engineering management tools and methods. Editor Phillip A. Laplante uses the most universally recognized definition of the areas of relevance to software engineering, the Software Engineering Body of Knowledge (SWEBOK®), as a template for organizing the material. Also available in an electronic format, this encyclopedia supplies software engineering students, IT professionals, researchers, managers, and scholars with unrivaled coverage of the topics that encompass this ever-changing field. Also Available Online This Taylor & Francis encyclopedia is also available through online subscription, offering a variety of extra benefits for researchers, students, and librarians, including: Citation tracking and alerts Active reference linking Saved searches and marked lists HTML and PDF format options Contact Taylor and Francis for more information or to inquire about subscription options and print/online combination packages. US: (Tel) 1.888.318.2367; (E-mail) [email protected] International: (Tel) +44 (0) 20 7017 6062; (E-mail) [email protected]
Download or read book Dreadnought written by April Daniels and published by Diversion Books. This book was released on 2016-01-24 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: A trans teen is transformed into a superhero in this action-packed series-starter perfect for fans of The Heroine Complex and Not Your Sidekick. Danny Tozer has a problem: she just inherited the powers of Dreadnought, the world’s greatest superhero. Until Dreadnought fell out of the sky and died right in front of her, Danny was trying to keep people from finding out she’s transgender. But before he expired, Dreadnought passed his mantle to her, and those secondhand superpowers transformed Danny’s body into what she’s always thought it should be. Now there’s no hiding that she’s a girl. It should be the happiest time of her life, but Danny’s first weeks finally living in a body that fits her are more difficult and complicated than she could have imagined. Between her father’s dangerous obsession with “curing” her girlhood, her best friend suddenly acting like he’s entitled to date her, and her fellow superheroes arguing over her place in their ranks, Danny feels like she’s in over her head. She doesn’t have time to adjust. Dreadnought’s murderer—a cyborg named Utopia—still haunts the streets of New Port City, threatening destruction. If Danny can’t sort through the confusion of coming out, master her powers, and stop Utopia in time, humanity faces extinction. “I didn’t know how much I needed this brave, thrilling book until it rocked my world. Dreadnought is the superhero adventure we all need right now.”—Charlie Jane Anders, author of All the Birds in the Sky “A thoroughly enjoyable, emotionally rich, action-packed story with the most exciting new superheroes in decades. Unmissable.”—Kirkus Reviews
Book Synopsis Artificial Intelligence and Machine Learning in Health Care and Medical Sciences by : Gyorgy J. Simon
Download or read book Artificial Intelligence and Machine Learning in Health Care and Medical Sciences written by Gyorgy J. Simon and published by Springer Nature. This book was released on with total page 824 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Success in Academic Surgery: Innovation and Entrepreneurship by : Mark S. Cohen
Download or read book Success in Academic Surgery: Innovation and Entrepreneurship written by Mark S. Cohen and published by Springer. This book was released on 2019-07-29 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a guide to innovation and entrepreneurship within academic surgery and details how these approaches can develop new technologies and programs that advance healthcare. The pathways, barriers, and opportunities for commercialization and entrepreneurship are identified and discussed in relation to licenses, start-ups, and obtaining funding. The book aims to help create a culture of innovation and entrepreneurship across academic medical centres around the world, with the belief that this can improve patient care. This book is relevant to surgeons of all disciplines, as well as medical students and researchers.
Book Synopsis 11th Mediterranean Conference on Medical and Biological Engineering and Computing 2007 by : Tomaz Jarm
Download or read book 11th Mediterranean Conference on Medical and Biological Engineering and Computing 2007 written by Tomaz Jarm and published by Springer Science & Business Media. This book was released on 2007-10-24 with total page 1183 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomedical engineering brings together bright minds from diverse disciplines, ranging from engineering, physics, and computer science to biology and medicine. This book contains the proceedings of the 11th Mediterranean Conference on Medical and Biological Engineering and Computing, MEDICON 2007, held in Ljubljana, Slovenia, June 2007. It features relevant, up-to-date research in the area.
Book Synopsis Towards Autonomous Robotic Systems by : Kaspar Althoefer
Download or read book Towards Autonomous Robotic Systems written by Kaspar Althoefer and published by Springer. This book was released on 2019-07-16 with total page 512 pages. Available in PDF, EPUB and Kindle. Book excerpt: The two volumes LNAI 11649 and 11650 constitute the refereed proceedings of the 20th Annual Conference "Towards Autonomous Robotics", TAROS 2019, held in London, UK, in July 2019. The 87 full papers and 12 short papers presented were carefully reviewed and selected from 101 submissions. The papers present and discuss significant findings and advances in autonomous robotics research and applications. They are organized in the following topical sections: robotic grippers and manipulation; soft robotics, sensing and mobile robots; robotic learning, mapping and planning; human-robot interaction; and robotic systems and applications.
Book Synopsis Software Engineering for Internet Applications by : Eve Astrid Andersson
Download or read book Software Engineering for Internet Applications written by Eve Astrid Andersson and published by Mit Press. This book was released on 2006 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: After completing this self-contained course on server-based Internet applications software that grew out of an MIT course, students who start with only the knowledge of how to write and debug a computer program will have learned how to build sophisticated Web-based applications.
Book Synopsis Medical Devices by : World Health Organization
Download or read book Medical Devices written by World Health Organization and published by World Health Organization. This book was released on 2010 with total page 147 pages. Available in PDF, EPUB and Kindle. Book excerpt: Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9
