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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."



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.



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.



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.



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.



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.



Patient Safety

Patient Safety Author Sidney Dekker
ISBN-10 9781439852262
Release 2016-04-19
Pages 262
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Increased concern for patient safety has put the issue at the top of the agenda of practitioners, hospitals, and even governments. The risks to patients are many and diverse, and the complexity of the healthcare system that delivers them is huge. Yet the discourse is often oversimplified and underdeveloped. Written from a scientific, human factors perspective, Patient Safety: A Human Factors Approach delineates a method that can enlighten and clarify this discourse as well as put us on a better path to correcting the issues. People often think, understandably, that safety lies mainly in the hands through which care ultimately flows to the patient—those who are closest to the patient, whose decisions can mean the difference between life and death, between health and morbidity. The human factors approach refuses to lay the responsibility for safety and risk solely at the feet of people at the sharp end. That is where we should intervene to make things safer, to tighten practice, to focus attention, to remind people to be careful, to impose rules and guidelines. The book defines an approach that looks relentlessly for sources of safety and risk everywhere in the system—the designs of devices; the teamwork and coordination between different practitioners; their communication across hierarchical and gender boundaries; the cognitive processes of individuals; the organization that surrounds, constrains, and empowers them; the economic and human resources offered; the technology available; the political landscape; and even the culture of the place. The breadth of the human factors approach is itself testimony to the realization that there are no easy answers or silver bullets for resolving the issues in patient safety. A user-friendly introduction to the approach, this book takes the complexity of health care seriously and doesn’t over simplify the problem. It demonstrates what the approach does do, that is offer the substance and guidance to consider the issues in all their nuance and complexity.



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.



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



The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices Author Amiram Daniel
ISBN-10 9780873897402
Release 2008-01-01
Pages 304
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How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes an update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs.



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."



Medical Device Design

Medical Device Design Author Peter J Ogrodnik
ISBN-10 9780123919434
Release 2012-12-17
Pages 376
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This book 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. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products



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.



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.



Design Controls Risk Management and Process Validation for Medical Device Professionals

Design Controls  Risk Management and Process Validation for Medical Device Professionals Author Vernon Geckler
ISBN-10 0692835415
Release 2017-02-11
Pages 442
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This handbook is the most exhaustive resource ever written about FDA design controls for medical devices. Four-hundred and forty, 8.5 X 11 pages provides a comprehensive and in depth evaluation of FDA Design Control Regulation (21 CFR 820.30). The author breaks down the regulation line by line and provides a detailed interpretation by using supportive evidence from the FDA design control guidance and the quality systems preamble. Numerous examples, case studies, best practices, 70+ figures and 45+ tables provide practical implementation techniques which are based on the author's extensive experience launching numerous medical device products and by integrating industry consultant expertise. This book covers basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading existing process to improve compliance. As an added bonus, web access to downloadable and editable design control development documents is included with this purchase. In addition, bonus chapters include: process validation, risk management, and the design control quality system preamble.



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



Class 1 Devices

Class 1 Devices Author Peter J Ogrodnik
ISBN-10 9780128007969
Release 2014-11-24
Pages 114
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The Case Studies in Medical Devices Design series consists of practical, applied case studies relating to medical device design in industry. These titles complement Ogrodnik’s Medical Device Design and will assist engineers with applying the theory in practice. The case studies presented directly relate to Class I, Class IIa, Class IIb and Class III medical devices. Designers and companies who wish to extend their knowledge in a specific discipline related to their respective class of operation will find any or all of these titles a great addition to their library. Class 1 Devices is a companion text to Medical Devices Design: Innovation from Concept to Market. The intention of this book, and its sister books in the series, is to support the concepts presented in Medical Devices Design through case studies. In the context of this book the case studies consider Class I (EU) and 510(k) exempt (FDA) . This book covers classifications, the conceptual and embodiment phase, plus design from idea to PDS. These titles will assist anyone who is working in the medical devices industry or who is studying biomedical subject areas to design a successful medical device and avoid repeating past mistakes. Written by an experienced medical device engineer and entrepreneur, with real world experience of developing and commercializing medical products. Joins up theory and practice in an accessible style.