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Medical Device Software Verification Validation and Compliance

Medical Device Software Verification  Validation and Compliance Author David A. Vogel
ISBN-10 9781596934238
Release 2010
Pages 444
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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."



Design Controls for the Medical Device Industry Second Edition

Design Controls for the Medical Device Industry  Second Edition Author Marie B. Teixeira
ISBN-10 9781466503557
Release 2013-11-12
Pages 205
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The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company’s design control program evolves in accordance with current industry practice. The text assists in the development of an effective design control program that not only satisfies the US FDA Quality System Regulation (QSR) and ISO 9001 and 13485 standards, but also meets today’s third-party auditor/investigator expectations and saves you valuable time and money. The author’s continual participation in FDA QSR inspections and Notified Body ISO audits is reflected in updates to all chapters and appendices of the book, now bursting at the seams with: New coverage of ISO 9001 and 13485 design control requirements More real-world examples from the medical device industry Additional detail for greater understanding and clarity Fresh templates for practical implementation Extensive references for further study The book addresses design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe.



Handbook of Human Factors in Medical Device Design

Handbook of Human Factors in Medical Device Design Author Matthew Bret Weinger
ISBN-10 1420063510
Release 2010-12-13
Pages 844
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Developed to promote the design of safe, effective, and usable medical devices, Handbook of Human Factors in Medical Device Design provides a single convenient source of authoritative information to support evidence-based design and evaluation of medical device user interfaces using rigorous human factors engineering principles. It offers guidance on user-centric design supported by discussions of design issues, case studies, and examples. The book sets the foundation with coverage of fundamental topics such as aligning the interactive nature of medical devices to the expected use environments ranging from hospitals and ambulances to patients’ homes, drawing on anthropometric and biomechanical data to ensure that designs match the intended users’ bodies and physical abilities, and conducting usability tests and other evaluations to ensure that devices perform as intended. It then focuses on applied design issues, offering guidance on the design of specific types of devices and designing devices for particular use environments. Adapted in part from established design standards and conventions, the design guidance presented in this work distills professional judgment extracted from the contributing authors’ years of experience in applied analysis and design. Written in true handbook style, each chapter stands alone and includes tables, illustrations, and cross references, allowing you to quickly find the exact information you need. Most chapters begin with a general introduction to the selected topic, followed by the presentation of general and special design considerations and then specific, numbered design guidelines. The book also presents a listing of resources, literature, and website references. It not only focuses on the human factors issues that arise when developing medical devices, it supplies the necessary guidance to resolve them.



Usability Testing of Medical Devices

Usability Testing of Medical Devices Author Michael E. Wiklund, P.E.
ISBN-10 1439811849
Release 2010-12-20
Pages 412
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To paraphrase a popular saying, usability testing should be done early and often. However, it doesn’t have to be an onerous process. Informative, practical, and engaging, Usability Testing of Medical Devices provides a simple, easy to implement general understanding of usability testing. It offers a general understanding of usability testing and reviews key concepts, highlighting the challenges of validating that protects against dangerous errors that could lead to patient injury and death. The book has been carefully designed to be concise and visually, easily read in one sitting or perused from one section to another as needed It begins with a review of human factors engineering and how usability testing fits in, and then discusses the government regulations and industry standards that have motivated many medical device manufacturers to conduct usability tests. It then covers the nitty-gritty of planning, conducting, and reporting the results of a usability test, making the process as smooth and painless as possible for the development team, and therefore making the medical devices they develop as safe, effective, and appealing as possible. As you read the book, keep in mind that, like snowflakes, each usability test is unique. And while 100 usability specialists working independently might take 100 different approaches to testing, albeit with considerable methodological overlap, there would also be meaningful differences that the practitioners would energetically defend as the best given the circumstances. To make your testing process easier, the authors, seasoned human factors specialists who have conducted thousands of test sessions involving medical devices used by physicians, nurses, therapists, technicians, and patients, have painstakingly put together an informative, practical, and engaging handbook for conducting usability tests of medical devices.



Medical Device Development

Medical Device Development Author Jonathan S. Kahan
ISBN-10 1882615921
Release 2009
Pages 546
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Medical Device Development has been writing in one form or another for most of life. You can find so many inspiration from Medical Device Development also informative, and entertaining. Click DOWNLOAD or Read Online button to get full Medical Device Development book for free.



Medical Device Use Error

Medical Device Use Error Author Michael Wiklund
ISBN-10 9781498705806
Release 2016-01-06
Pages 245
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Medical Device Use Error: Root Cause Analysis offers practical guidance on how to methodically discover and explain the root cause of a use error—a mistake—that occurs when someone uses a medical device. Covering medical devices used in the home and those used in clinical environments, the book presents informative case studies about the use errors (mistakes) that people make when using a medical device, the potential consequences, and design-based preventions. Using clear illustrations and simple narrative explanations, the text: Covers the fundamentals and language of root cause analysis and regulators’ expectations regarding the thorough analysis of use errors Describes how to identify use errors, interview users about use errors, and fix user interface design flaws that could induce use errors Reinforces the application of best practices in human factors engineering, including conducting both formative and summative usability tests Medical Device Use Error: Root Cause Analysis delineates a systematic method of analyzing medical device use errors. The book provides a valuable reference to human factors specialists, product development professionals, and others committed to making medical devices as safe and effective as possible.



Software Quality Assurance

Software Quality Assurance Author Alain April
ISBN-10 9781118501825
Release 2018-01-04
Pages 624
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The most comprehensive General, Organic, and Biochemistry book available, Introduction to General, Organic, and Biochemistry, 11th Edition continues its tradition of a solid development of problem-solving skills, numerous examples and practice problems, along with coverage of current applications. Written by an experienced author team, they skillfully anticipate areas of difficulty and pace the book accordingly. Readers will find the right mix of general chemistry compared to the discussions on organic and biochemistry. Introduction to General, Organic, and Biochemistry, 11th Edition has clear & logical explanations of chemical concepts and great depth of coverage as well as a clear, consistent writing style which provides great readability. An emphasis on Real-World aspects of chemistry makes the reader comfortable in seeing how the chemistry will apply to their career.



The Medical Device R D Handbook

The Medical Device R D Handbook Author Theodore R. Kucklick
ISBN-10 9781420038354
Release 2005-11-21
Pages 376
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The Medical Device R&D Handbook presents a wealth of information for the hands-on design and building of medical devices. Detailed information on such diverse topics as catheter building, prototyping, materials, processes, regulatory issues, and much more are available in this convenient handbook for the first time. The Medical Device R&D Handbook also includes exclusive interviews with pioneers and leaders in the medical device industry, offering an insider's perspective on issues that are critical to the medical device entrepreneur. Highlights Include... An Introduction to Medical Plastics Catheter Forming Equipment and Operations Basics of Catheter Construction Basics of Medical Needles Rapid Prototyping for Medical Devices Reverse Engineering for Medical Devices Using Medical Illustration in Product Development Introduction to Pre-Clinical Studies Introduction to Regulatory Affairs Assessing Biocompatibility Exclusive Interviews with Key Industry Leaders ...And More This practical handbook is a unique, insightful guide that helps you design, test, and successfully introduce new medical devices to the marketplace.



The Medical Device Validation Handbook

The Medical Device Validation Handbook Author Robert Packard
ISBN-10 0967311527
Release 2015-04-05
Pages 258
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Reference text on validation processes for manufacturing medical devices.



Scaling Software Agility

Scaling Software Agility Author Dean Leffingwell
ISBN-10 9780321630063
Release 2007-02-26
Pages 384
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“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.



Medical Device Quality Assurance and Regulatory Compliance

Medical Device Quality Assurance and Regulatory Compliance Author Richard C. Fries
ISBN-10 0824701771
Release 1998-08-11
Pages 496
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"Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."



Software and Systems Traceability

Software and Systems Traceability Author Jane Huang
ISBN-10 9781447122395
Release 2012-02-01
Pages 494
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Software and Systems Traceability provides a comprehensive description of the practices and theories of software traceability across all phases of the software development lifecycle. The term software traceability is derived from the concept of requirements traceability. Requirements traceability is the ability to track a requirement all the way from its origins to the downstream work products that implement that requirement in a software system. Software traceability is defined as the ability to relate the various types of software artefacts created during the development of software systems. Traceability relations can improve the quality of a product being developed, and reduce the time and cost of development. More specifically, traceability relations can support evolution of software systems, reuse of parts of a system by comparing components of new and existing systems, validation that a system meets its requirements, understanding of the rationale for certain design and implementation decisions, and analysis of the implications of changes in the system.



Verification and Validation in Systems Engineering

Verification and Validation in Systems Engineering Author Mourad Debbabi
ISBN-10 3642152287
Release 2010-11-16
Pages 248
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At the dawn of the 21st century and the information age, communication and c- puting power are becoming ever increasingly available, virtually pervading almost every aspect of modern socio-economical interactions. Consequently, the potential for realizing a signi?cantly greater number of technology-mediated activities has emerged. Indeed, many of our modern activity ?elds are heavily dependant upon various underlying systems and software-intensive platforms. Such technologies are commonly used in everyday activities such as commuting, traf?c control and m- agement, mobile computing, navigation, mobile communication. Thus, the correct function of the forenamed computing systems becomes a major concern. This is all the more important since, in spite of the numerous updates, patches and ?rmware revisions being constantly issued, newly discovered logical bugs in a wide range of modern software platforms (e. g. , operating systems) and software-intensive systems (e. g. , embedded systems) are just as frequently being reported. In addition, many of today’s products and services are presently being deployed in a highly competitive environment wherein a product or service is succeeding in most of the cases thanks to its quality to price ratio for a given set of features. Accordingly, a number of critical aspects have to be considered, such as the ab- ity to pack as many features as needed in a given product or service while c- currently maintaining high quality, reasonable price, and short time -to- market.



Practical Process Validation

Practical Process Validation Author Mark Allen Durivage
ISBN-10 9780873899369
Release 2016-07-14
Pages 168
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For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. This poses a substantial problem for the medical device industry and is the reason why the authors wanted to write this book. The authors will share their collective knowledge: to help organizations improve patient safety and increase profitability while maintaining a state of compliance with regulations and standards. The intent of this book is to provide manufacturing quality professionals working in virtually any industry a quick, convenient, and comprehensive guide to properly conduct process validations that meet regulatory and certification requirements. It will aid quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities.



Mission Critical and Safety Critical Systems Handbook

Mission Critical and Safety Critical Systems Handbook Author Kim Fowler
ISBN-10 0080942555
Release 2009-11-19
Pages 592
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This handbook provides a consolidated, comprehensive information resource for engineers working with mission and safety critical systems. Principles, regulations, and processes common to all critical design projects are introduced in the opening chapters. Expert contributors then offer development models, process templates, and documentation guidelines from their own core critical applications fields: medical, aerospace, and military. Readers will gain in-depth knowledge of how to avoid common pitfalls and meet even the strictest certification standards. Particular emphasis is placed on best practices, design tradeoffs, and testing procedures. *Comprehensive coverage of all key concerns for designers of critical systems including standards compliance, verification and validation, and design tradeoffs *Real-world case studies contained within these pages provide insight from experience



Medical Device Regulatory Practices

Medical Device Regulatory Practices Author Val Theisz
ISBN-10 9789814669115
Release 2015-08-03
Pages 590
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This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success. Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators’ language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.



Pharmaceutical Computer Systems Validation

Pharmaceutical Computer Systems Validation Author Guy Wingate
ISBN-10 9781420088953
Release 2016-04-19
Pages 798
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Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system. Key topics in Pharmaceutical Computer Systems Validation, Second Edition include: GAMP5, ASTM 2500, EU GMP (Annex 11), and US GMP revisions to regulatory requirements for electronic records and signatures that should be published in 2008 ICH Guidance Q8, Q9, and Q10 expectations FDA cGMPs for the 21st Century Initiative and associated guidance PIC/S Guidance on Good Practice for Computerized Systems in GxP Environments WK9864 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment the indirect developments from FDA/EU/Japan regulators and industry the role of QA department, and internal and external suppliers the integration of computer systems validation into single overall approach for wider system practical guidance on handling common high, medium, and low risk issues that can occur during the life cycle of a computer system managing outsource partners and handling legacy systems topical issues uncovered by regulatory authorities including US FDA