Medical Grade Software Development
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| Author | : Ilkka Juuso |
| Publisher | : CRC Press |
| Total Pages | : 256 |
| Release | : 2023-11-13 |
| Genre | : Business & Economics |
| ISBN | : 1000987906 |
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.
| Author | : John Zaleski |
| Publisher | : John Wiley & Sons |
| Total Pages | : 354 |
| Release | : 2008-12-23 |
| Genre | : Health & Fitness |
| ISBN | : 3895786322 |
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.
| Author | : Philip S. Cosgriff |
| Publisher | : CRC Press |
| Total Pages | : 223 |
| Release | : 2024-03-26 |
| Genre | : Science |
| ISBN | : 1040002358 |
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 | : Ilkka Juuso |
| Publisher | : CRC Press |
| Total Pages | : 371 |
| Release | : 2022-03-20 |
| Genre | : Business & Economics |
| ISBN | : 1000550664 |
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.
| Author | : Ilkka Juuso |
| Publisher | : Productivity Press |
| Total Pages | : 346 |
| Release | : 2022-03-21 |
| Genre | : Medical instruments and apparatus industry |
| ISBN | : 9781032065731 |
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.
| Author | : Michaela Huhn |
| Publisher | : Springer |
| Total Pages | : 249 |
| Release | : 2017-07-26 |
| Genre | : Computers |
| ISBN | : 3319631942 |
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.
| Author | : Peter J. Ogrodnik |
| Publisher | : Academic Press |
| Total Pages | : 540 |
| Release | : 2019-10-30 |
| Genre | : Technology & Engineering |
| ISBN | : 0128149639 |
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
| Author | : Steven Holfinger |
| Publisher | : Elsevier Health Sciences |
| Total Pages | : 145 |
| Release | : 2023-08-03 |
| Genre | : Medical |
| ISBN | : 0443182418 |
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.
| Author | : |
| Publisher | : |
| Total Pages | : 1692 |
| Release | : 2007 |
| Genre | : Medical instruments and apparatus |
| ISBN | : |
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.
| Author | : Phillip A. Laplante |
| Publisher | : CRC Press |
| Total Pages | : 1441 |
| Release | : 2010-11-22 |
| Genre | : Computers |
| ISBN | : 1351249266 |
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]
