Medical Grade Software Development

Author : Ilkka Juuso,Ilpo Pöyhönen
Publisher : CRC Press
Page : 256 pages
File Size : 52,9 Mb
Release : 2023-11-13
Category : Business & Economics
ISBN : 9781000987904

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Medical-Grade Software Development by Ilkka Juuso,Ilpo Pöyhönen Pdf

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 : David A. Vogel
Publisher : Artech House
Page : 445 pages
File Size : 44,8 Mb
Release : 2011
Category : Medical
ISBN : 9781596934238

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Medical Device Software Verification, Validation and Compliance by David A. Vogel Pdf

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 : Gloria Hall
Publisher : Unknown
Page : 128 pages
File Size : 45,6 Mb
Release : 2021-04-23
Category : Electronic
ISBN : 1947493612

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Software As a Medical Device by Gloria Hall Pdf

Author : Xenophon Papademetris,Ayesha N. Quraishi,Gregory P. Licholai
Publisher : Cambridge University Press
Page : 341 pages
File Size : 49,8 Mb
Release : 2022-05-05
Category : Business & Economics
ISBN : 9781316514993

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Introduction to Medical Software by Xenophon Papademetris,Ayesha N. Quraishi,Gregory P. Licholai Pdf

A concise and accessible overview of the design, implementation and management of medical software.

Author : Antonio Coronato
Publisher : IET
Page : 297 pages
File Size : 41,6 Mb
Release : 2018-02
Category : Science
ISBN : 9781785612480

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Engineering High Quality Medical Software by Antonio Coronato Pdf

This book focuses on high-confidence medical software in the growing field of e-health, telecare services and health technology. It covers the development of methodologies and engineering tasks together with standards and regulations for medical software.

Author : Ilkka Juuso
Publisher : CRC Press
Page : 331 pages
File Size : 47,9 Mb
Release : 2022-03-20
Category : Business & Economics
ISBN : 9781000550689

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Developing an ISO 13485-Certified Quality Management System by Ilkka Juuso Pdf

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 : Philip S. Cosgriff,Matthew J. Memmott
Publisher : CRC Press
Page : 223 pages
File Size : 54,7 Mb
Release : 2024-03-26
Category : Science
ISBN : 9781040002353

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Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations by Philip S. Cosgriff,Matthew J. Memmott Pdf

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 : Antonio Coronato
Publisher : Unknown
Page : 297 pages
File Size : 44,9 Mb
Release : 2018
Category : Medical care
ISBN : 1523115351

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Engineering High Quality Medical Software by Antonio Coronato Pdf

This book focuses on high-confidence medical software in the growing field of e-health, telecare services and health technology. It covers the development of methodologies and engineering tasks together with standards and regulations for medical software.

Author : Phillip A. Laplante
Publisher : CRC Press
Page : 1441 pages
File Size : 43,5 Mb
Release : 2010-11-22
Category : Computers
ISBN : 9781351249263

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Encyclopedia of Software Engineering Three-Volume Set (Print) by Phillip A. Laplante Pdf

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]

Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publisher : National Academies Press
Page : 132 pages
File Size : 40,7 Mb
Release : 2011-06-10
Category : Medical
ISBN : 9780309162067

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Public Health Effectiveness of the FDA 510(k) Clearance Process by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Pdf

The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already legally on the market (called a predicate), in which case the device does not need to go through the premarket approval (PMA) process. As part of its assessment of the FDA's premarket clearance process for medical devices, the Institute of Medicine (IOM) held a workshop on July 28, 2010 to discuss how medical devices are monitored for safety after they are available to consumers. Its primary focus was on monitoring the safety of marketed medical devices, including FDA's postmarket surveillance activities, analysis of safety concerns that resulted in medical device recalls, and non-FDA sources of adverse-event information. Public Health Effectiveness of the FDA 501(K) Clearance Process summarizes the views of the workshop participants.

Author : Richard C. Fries
Publisher : CRC Press
Page : 491 pages
File Size : 52,8 Mb
Release : 2019-08-15
Category : Medical
ISBN : 9781000696950

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Handbook of Medical Device Design by Richard C. Fries Pdf

First published in 2001: This handbook has been written to give those professionals working in the development and use of medical devices practical knowledge about biomedical technology, regulations, and their relationship to quality health care.

Author : Joseph F. Dyro
Publisher : Academic Press
Page : 696 pages
File Size : 54,7 Mb
Release : 2004-08-27
Category : Medical
ISBN : 9780122265709

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Clinical Engineering Handbook by Joseph F. Dyro Pdf

As the biomedical engineering field expands throughout the world, clinical engineers play an ever more important role as the translator between the worlds of the medical, engineering, and business professionals. They influence procedure and policy at research facilities, universities and private and government agencies including the Food and Drug Administration and the World Health Organization. Clinical engineers were key players in calming the hysteria over electrical safety in the 1970s and Y2K at the turn of the century and continue to work for medical safety. This title brings together all the important aspects of Clinical Engineering. It provides the reader with prospects for the future of clinical engineering as well as guidelines and standards for best practice around the world.

Author : Dean Leffingwell
Publisher : Pearson Education
Page : 616 pages
File Size : 40,8 Mb
Release : 2007-02-26
Category : Computers
ISBN : 9780321630063

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Scaling Software Agility by Dean Leffingwell Pdf

“Companies have been implementing large agile projects for a number of years, but the ‘stigma’ of ‘agile only works for small projects’ continues to be a frequent barrier for newcomers and a rallying cry for agile critics. What has been missing from the agile literature is a solid, practical book on the specifics of developing large projects in an agile way. Dean Leffingwell’s book Scaling Software Agility fills this gap admirably. It offers a practical guide to large project issues such as architecture, requirements development, multi-level release planning, and team organization. Leffingwell’s book is a necessary guide for large projects and large organizations making the transition to agile development.” —Jim Highsmith, director, Agile Practice, Cutter Consortium, author of Agile Project Management “There’s tension between building software fast and delivering software that lasts, between being ultra-responsive to changes in the market and maintaining a degree of stability. In his latest work, Scaling Software Agility, Dean Leffingwell shows how to achieve a pragmatic balance among these forces. Leffingwell’s observations of the problem, his advice on the solution, and his description of the resulting best practices come from experience: he’s been there, done that, and has seen what’s worked.” —Grady Booch, IBM Fellow Agile development practices, while still controversial in some circles, offer undeniable benefits: faster time to market, better responsiveness to changing customer requirements, and higher quality. However, agile practices have been defined and recommended primarily to small teams. In Scaling Software Agility, Dean Leffingwell describes how agile methods can be applied to enterprise-class development. Part I provides an overview of the most common and effective agile methods. Part II describes seven best practices of agility that natively scale to the enterprise level. Part III describes an additional set of seven organizational capabilities that companies can master to achieve the full benefits of software agility on an enterprise scale. This book is invaluable to software developers, testers and QA personnel, managers and team leads, as well as to executives of software organizations whose objective is to increase the quality and productivity of the software development process but who are faced with all the challenges of developing software on an enterprise scale.

Author : Johan Helmenkamp,Robert Bujila,Gavin Poludniowski
Publisher : CRC Press
Page : 292 pages
File Size : 45,7 Mb
Release : 2020-11-23
Category : Medical
ISBN : 9781351188180

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Diagnostic Radiology Physics with MATLAB® by Johan Helmenkamp,Robert Bujila,Gavin Poludniowski Pdf

Imaging modalities in radiology produce ever-increasing amounts of data which need to be displayed, optimized, analyzed and archived: a "big data" as well as an "image processing" problem. Computer programming skills are rarely emphasized during the education and training of medical physicists, meaning that many individuals enter the workplace without the ability to efficiently solve many real-world clinical problems. This book provides a foundation for the teaching and learning of programming for medical physicists and other professions in the field of Radiology and offers valuable content for novices and more experienced readers alike. It focuses on providing readers with practical skills on how to implement MATLAB® as an everyday tool, rather than on solving academic and abstract physics problems. Further, it recognizes that MATLAB is only one tool in a medical physicist’s toolkit and shows how it can be used as the "glue" to integrate other software and processes together. Yet, with great power comes great responsibility. The pitfalls to deploying your own software in a clinical environment are also clearly explained. This book is an ideal companion for all medical physicists and medical professionals looking to learn how to utilize MATLAB in their work. Features Encompasses a wide range of medical physics applications in diagnostic and interventional radiology Advances the skill of the reader by taking them through real-world practical examples and solutions with access to an online resource of example code The diverse examples of varying difficulty make the book suitable for readers from a variety of backgrounds and with different levels of programming experience.

Author : Rory V. Connor,Jan Pries-Heje,Richard Messnarz
Publisher : Springer Science & Business Media
Page : 322 pages
File Size : 49,9 Mb
Release : 2011-06-22
Category : Computers
ISBN : 9783642222054

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Systems, Software and Services Process Improvement by Rory V. Connor,Jan Pries-Heje,Richard Messnarz Pdf

This volume constitutes the refereed proceedings of the 18th EuroSPI conference, held in Roskilde, Denmark, in June 2011. The 18 revised full papers presented together with 9 key notes were carefully reviewed and selected. They are organized in topical sections on SPI and assessments; SPI and implementation; SPI and improvement methods; SPI organization; SPI people/ teams; SPI and reuse; selected key notes for SPI implementation.