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Iso 13485 For Engineers
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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 The Medical Device Engineers Handbook by : Emmet Tobin
Download or read book The Medical Device Engineers Handbook written by Emmet Tobin and published by . This book was released on 2016-06-01 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book aims to create a new standard resource for engineers working in the medical device industry. The objective was to produce an all-in-one reference-style book serving the needs of engineers at different levels in their career journey. It is based on over a decade of experience working within the industry. It draws not only on this experience but on best practices and widely accepted conventions. These practices and conventions are typically shaped by the demands of regulatory bodies and international organisations. Chapters include: Design Controls Validation Planning Risk Management Facilities and Utilities Validation Equipment and Software Validation Process Validation Packaging Validation Test Method Validation 21 CFR Part 11 Electronic Records Measurement Good Manufacturing Practices ISO 13485 Lean Basics Six Sigma Basics Polymer Processing Tools Useful References Page Count (Over 200 pages)
Book Synopsis Mechanical Engineers' Handbook, Volume 3 by : Myer Kutz
Download or read book Mechanical Engineers' Handbook, Volume 3 written by Myer Kutz and published by John Wiley & Sons. This book was released on 2015-02-06 with total page 882 pages. Available in PDF, EPUB and Kindle. Book excerpt: Full coverage of manufacturing and management in mechanical engineering Mechanical Engineers' Handbook, Fourth Edition provides a quick guide to specialized areas that engineers may encounter in their work, providing access to the basics of each and pointing toward trusted resources for further reading, if needed. The book's accessible information offers discussions, examples, and analyses of the topics covered, rather than the straight data, formulas, and calculations found in other handbooks. No single engineer can be a specialist in all areas that they are called upon to work in. It's a discipline that covers a broad range of topics that are used as the building blocks for specialized areas, including aerospace, chemical, materials, nuclear, electrical, and general engineering. This third volume of Mechanical Engineers' Handbook covers Manufacturing & Management, and provides accessible and in-depth access to the topics encountered regularly in the discipline: environmentally benign manufacturing, production planning, production processes and equipment, manufacturing systems evaluation, coatings and surface engineering, physical vapor deposition, mechanical fasteners, seal technology, statistical quality control, nondestructive inspection, intelligent control of material handling systems, and much more. Presents the most comprehensive coverage of the entire discipline of Mechanical Engineering Focuses on the explanation and analysis of the concepts presented as opposed to a straight listing of formulas and data found in other handbooks Offers the option of being purchased as a four-book set or as single books Comes in a subscription format through the Wiley Online Library and in electronic and other custom formats Engineers at all levels of industry, government, or private consulting practice will find Mechanical Engineers' Handbook, Volume 3 an "off-the-shelf" reference they'll turn to again and again.
Download or read book ISO 13485 written by Itay Abuhav and published by CRC Press. This book was released on 2011-10-20 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: Although complex and lengthy, the process of certification for the ISO 13485 can be easily mastered using the simple method outlined in ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry. Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 Standard certification for medical device manufacturing. Filled with examples drawn from the author’s experience and spanning different sectors and fields of the medical device industry, the book translates the extra ordinary requirements and objectives of the standard into feasible activities and tasks. The book provides a full analysis of each clause and sub clause through quality perspectives: the implications on an organization, its processes, management, human resources, infrastructures, work environment, control and effectiveness, documentations and records. The book is organized like the standard itself — the table of contents is identical to the ISO 13485 Standard’s table of contents — making it user friendly, familiar, and unintimidating. You can use the book as a consulting session — read it, explore it ,extract ideas — and draw on the information and knowledge that suits you and your organization, and then apply it effectively to your quality management system and processes.
Book Synopsis A Practical Field Guide for ISO 13485:2016 by : Erik V. Myhrberg
Download or read book A Practical Field Guide for ISO 13485:2016 written by Erik V. Myhrberg and published by Quality Press. This book was released on 2019-11-06 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this expanded field guide is to assist organizations, step-by-step, in implementing a quality management system (QMS) in conformance with ISO 13485:2016, whether "from scratch" or by transitioning from variations of the ISO 13485 family. In keeping with ISO 9000:2015's definition of quality as the "degree to which a set of inherent characteristics fulfills requirements," Myhrberg, Raciti, and Myhrberg have identified the requirements and inherent characteristics (distinguishing features) for this expanded field guide. Within the guide, each subclause containing requirements is the focus of a two-page visual spread that consistently presents features that fulfill the requirements listed below. This guide will: Provide a user-friendly guide to ISO 13485:2016's requirements for implementation purposes -Identify the documents/documentation required, along with recommendations on what to consider retaining/adding to a QMS during ISO 13485:2016 implementation -Guide internal auditor(s) regarding what to ask to verify that a conforming and effective QMS exists -Direct management on what it must do and should consider to satisfy ISO 13485:2016's enhanced requirements, as well as on the responsibilities for top management -Depict step-by-step in flowchart form what must occur to create an effective, conforming QMS
Book Synopsis Medical Device Cybersecurity for Engineers and Manufacturers by : Axel Wirth
Download or read book Medical Device Cybersecurity for Engineers and Manufacturers written by Axel Wirth and published by Artech House. This book was released on 2020-08-31 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cybersecurity for medical devices is no longer optional. We must not allow sensationalism or headlines to drive the discussion… Nevertheless, we must proceed with urgency. In the end, this is about preventing patient harm and preserving patient trust. A comprehensive guide to medical device secure lifecycle management, this is a book for engineers, managers, and regulatory specialists. Readers gain insight into the security aspects of every phase of the product lifecycle, including concept, design, implementation, supply chain, manufacturing, postmarket surveillance, maintenance, updates, and end of life. Learn how to mitigate or completely avoid common cybersecurity vulnerabilities introduced during development and production. Grow your awareness of cybersecurity development topics ranging from high-level concepts to practical solutions and tools. Get insight into emerging regulatory and customer expectations. Uncover how to minimize schedule impacts and accelerate time-to-market while still accomplishing the main goal: reducing patient and business exposure to cybersecurity risks. Medical Device Cybersecurity for Engineers and Manufacturers is designed to help all stakeholders lead the charge to a better medical device security posture and improve the resilience of our medical device ecosystem.
Book Synopsis Engineering Innovation by : Benjamin M. Legum
Download or read book Engineering Innovation written by Benjamin M. Legum and published by Walter de Gruyter GmbH & Co KG. This book was released on 2019-07-08 with total page 533 pages. Available in PDF, EPUB and Kindle. Book excerpt: Engineering Innovation is an overview of the interconnected business and product development techniques needed to nurture the development of raw, emerging technologies into commercially viable products. This book relates Funding Strategies, Business Development, and Product Development to one another as an idea is refined to a validated concept, iteratively developed into a product, then produced for commercialization. Engineering Innovation also provides an introduction to business strategies and manufacturing techniques on a technical level designed to encourage passionate clinicians, academics, engineers and savvy entrepreneurs. Offers a comprehensive overview of the process of bringing new technology to market. Identifies a variety of technology management skill sets and management tools. Explores concept generation in conjunction with intellectual property development for early-stage companies. Explores Quality and Transfer-to-Manufacturing.
Download or read book Engineering Rules written by JoAnne Yates and published by JHU Press. This book was released on 2019-06-11 with total page 439 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first global history of voluntary consensus standard setting. Finalist, Hagley Prize in Business History, The Hagley Museum and Library / The Business History Conference Private, voluntary standards shape almost everything we use, from screw threads to shipping containers to e-readers. They have been critical to every major change in the world economy for more than a century, including the rise of global manufacturing and the ubiquity of the internet. In Engineering Rules, JoAnne Yates and Craig N. Murphy trace the standard-setting system's evolution through time, revealing a process with an astonishingly pervasive, if rarely noticed, impact on all of our lives. This type of standard setting was established in the 1880s, when engineers aimed to prove their status as professionals by creating useful standards that would be widely adopted by manufacturers while satisfying corporate customers. Yates and Murphy explain how these engineers' processes provided a timely way to set desirable standards that would have taken much longer to emerge from the market and that governments were rarely willing to set. By the 1920s, the standardizers began to think of themselves as critical to global prosperity and world peace. After World War II, standardizers transcended Cold War divisions to create standards that made the global economy possible. Finally, Yates and Murphy reveal how, since 1990, a new generation of standardizers has focused on supporting the internet and web while applying the same standard-setting process to regulate the potential social and environmental harms of the increasingly global economy. Drawing on archival materials from three continents, Yates and Murphy describe the positive ideals that sparked the standardization movement, the ways its leaders tried to realize those ideals, and the challenges the movement faces today. Engineering Rules is a riveting global history of the people, processes, and organizations that created and maintain this nearly invisible infrastructure of today's economy, which is just as important as the state or the global market.
Book Synopsis Clinical Engineering Handbook by : Ernesto Iadanza
Download or read book Clinical Engineering Handbook written by Ernesto Iadanza and published by Academic Press. This book was released on 2019-12-06 with total page 960 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Engineering Handbook, Second Edition, covers modern clinical engineering topics, giving experienced professionals the necessary skills and knowledge for this fast-evolving field. Featuring insights from leading international experts, this book presents traditional practices, such as healthcare technology management, medical device service, and technology application. In addition, readers will find valuable information on the newest research and groundbreaking developments in clinical engineering, such as health technology assessment, disaster preparedness, decision support systems, mobile medicine, and prospects and guidelines on the future of clinical engineering.As the biomedical engineering field expands throughout the world, clinical engineers play an increasingly important role as translators between the medical, engineering and business professions. In addition, they influence procedures and policies at research facilities, universities, and in private and government agencies. This book explores their current and continuing reach and its importance. - Presents a definitive, comprehensive, and up-to-date resource on clinical engineering - Written by worldwide experts with ties to IFMBE, IUPESM, Global CE Advisory Board, IEEE, ACCE, and more - Includes coverage of new topics, such as Health Technology Assessment (HTA), Decision Support Systems (DSS), Mobile Apps, Success Stories in Clinical Engineering, and Human Factors Engineering
Book Synopsis Introduction to Product Design and Development for Engineers by : Dr. Ali Jamnia
Download or read book Introduction to Product Design and Development for Engineers written by Dr. Ali Jamnia and published by CRC Press. This book was released on 2018-06-01 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introduction to Product Design and Development for Engineers provides guidelines and best practices for the design, development, and evaluation of engineered products. Created to serve fourth year undergraduate students in Engineering Design modules with a required project, the text covers the entire product design process and product life-cycle, from the initial concept to the design and development stages, and through to product testing, design documentation, manufacturability, marketing, and sustainability. Reflecting the author's long career as a design engineer, this text will also serve as a practical guide for students working on their capstone design projects.
Download or read book ISO 13485:2016 written by Itay Abuhav and published by CRC Press. This book was released on 2018-05-11 with total page 735 pages. Available in PDF, EPUB and Kindle. Book excerpt: Summary: This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more than 800-page length, the author has specifically designed its contents to maximize usability for the reader with a table of contents identical to that of the ISO standard itself, which enables easy navigation and orientation. Pragmatic in style and down to earth in tone, this book draws real-life examples and case-studies from the author’s many years of experience in consulting to illustrate even the most complex of ISO 13485:2016 standard requirements and their implementation. Identifying relevant requirements and how they harmonize with quality management systems, developing processes for design and development, as well as product realization and validation are just a few of the issues covered in-depth by this publication. In addition, the author constantly reviews the distinctive characteristics and aspects of the medical device manufacturing industry, so that the reader can also appreciate the subject of this book in an everyday context. Features: A pragmatic and down to earth approach towards the reader’s understanding of ISO 13485:2016 standard requirements implementation. Uses examples and cases from real-life based on the author’s many years of experience in quality management. A table of contents structured identically to that of ISO 13485:2016 itself, allowing easier navigation and orientation for the reader. Emphasises guidance for ISO 13495:2016 standard requirements which are difficult to interpret and implement Constantly reviews the aspect of medical device industry characteristics and distinctive so the reader can reflect the content with its daily work.
Book Synopsis Requirements Engineering for Digital Health by : Samuel A. Fricker
Download or read book Requirements Engineering for Digital Health written by Samuel A. Fricker and published by Springer. This book was released on 2014-11-14 with total page 209 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare and well-being have captured the attention of established software companies, start-ups, and investors. Software is starting to play a central role for addressing the problems of the aging society and the escalating cost of healthcare services. Enablers of such digital health are a growing number of sensors for sensing the human body and communication infrastructure for remote meetings, data sharing, and messaging. The challenge that lies in front of us is how to effectively make use of these capabilities, for example to empower patients and to free the scarce resources of medical personnel. Requirements engineering is the process by which the capabilities of a software product are aligned with stakeholder needs and a shared understanding between the stakeholders and development team established. This book provides guide for what to look for and do when inquiring and specifying software that targets healthcare and well-being, helping readers avoid the pitfalls of the highly regulated and sensible healthcare domain are and how they can be overcome. This book brings together the knowledge of 22 researchers, engineers, lawyers, and CEOs that have experience in the development of digital health solutions. It represents a unique line-up of best practices and recommendations of how to engineer requirements for digital health. In particular the book presents: · The area of digital health, e-health, and m-health · Best practice for requirements engineering based on evidence from a large number of projects · Practical step-by-step guidelines, examples, and lessons-learned for working with laws, regulations, ethical issues, interoperability, user experience, security, and privacy · How to put these many concerns together for engineering the requirements of a digital health solution and for scaling a digital health product For anybody who intends to develop software for digital health, this book is an introduction and reference with a wealth of actionable insights. For students interested in understanding how to apply software to healthcare, the text introduces key topics and guides further studies with references to important literature.
Book Synopsis Exploring Biomedical Engineering by : Cybellium
Download or read book Exploring Biomedical Engineering written by Cybellium and published by Cybellium . This book was released on with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: Welcome to the forefront of knowledge with Cybellium, your trusted partner in mastering the cutting-edge fields of IT, Artificial Intelligence, Cyber Security, Business, Economics and Science. Designed for professionals, students, and enthusiasts alike, our comprehensive books empower you to stay ahead in a rapidly evolving digital world. * Expert Insights: Our books provide deep, actionable insights that bridge the gap between theory and practical application. * Up-to-Date Content: Stay current with the latest advancements, trends, and best practices in IT, Al, Cybersecurity, Business, Economics and Science. Each guide is regularly updated to reflect the newest developments and challenges. * Comprehensive Coverage: Whether you're a beginner or an advanced learner, Cybellium books cover a wide range of topics, from foundational principles to specialized knowledge, tailored to your level of expertise. Become part of a global network of learners and professionals who trust Cybellium to guide their educational journey. www.cybellium.com
Book Synopsis SOFTWARE ENGINEERING: A SYSTEMATIC APPROACH by : Dr. Shakti Kundu
Download or read book SOFTWARE ENGINEERING: A SYSTEMATIC APPROACH written by Dr. Shakti Kundu and published by Lulu Publication. This book was released on 2020-07-06 with total page 94 pages. Available in PDF, EPUB and Kindle. Book excerpt: Software Engineering Approach Software engineering is an engineering discipline that's applied to the development of software in a systematic approach (called a software process). It's the application of theories, methods, and tools to design build a software that meets the specifications efficiently, cost-effectively, and ensuring quality. Need of Engineering Aspect of Software Design Software design is the process by which an agent creates a specification of a software artifact, intended to accomplish goals, using a set of primitive components and subject to constraints Software design may refer to either "all the activity involved in conceptualizing, framing, implementing, commissioning, and ultimately modifying complex systems" or "the activity following requirements specification and before programming, as ... [in] a stylized software engineering process." Software design usually involves problem solving and planning a software solution. This includes both a low-level component and algorithm design and a high-level, architecture design.
Book Synopsis Biomedical Engineering by : Reza Fazel-Rezai
Download or read book Biomedical Engineering written by Reza Fazel-Rezai and published by BoD – Books on Demand. This book was released on 2011-08-29 with total page 502 pages. Available in PDF, EPUB and Kindle. Book excerpt: In all different areas in biomedical engineering, the ultimate objectives in research and education are to improve the quality life, reduce the impact of disease on the everyday life of individuals, and provide an appropriate infrastructure to promote and enhance the interaction of biomedical engineering researchers. This book is prepared in two volumes to introduce a recent advances in different areas of biomedical engineering such as biomaterials, cellular engineering, biomedical devices, nanotechnology, and biomechanics. It is hoped that both of the volumes will bring more awareness about the biomedical engineering field and help in completing or establishing new research areas in biomedical engineering.
Book Synopsis Electrical Product Compliance and Safety Engineering, Volume 2 by : Steli Loznen
Download or read book Electrical Product Compliance and Safety Engineering, Volume 2 written by Steli Loznen and published by Artech House. This book was released on 2021-09-30 with total page 350 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Engineering Open-Source Medical Devices by : Arti Ahluwalia
Download or read book Engineering Open-Source Medical Devices written by Arti Ahluwalia and published by Springer Nature. This book was released on 2022-02-23 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on the challenges and potentials of open source and collaborative design approaches and strategies in the biomedical field. It provides a comprehensive set of good practices and methods for making these safe, innovative and certifiable biomedical devices reach patients and provide successful solutions to healthcare issues. The chapters are sequenced to follow the complete lifecycle of open source medical technologies. The information provided is eminently practical, as it is supported by real cases of study, in which collaboration among medical professionals, engineers and technicians, patients and patient associations, policy makers, regulatory bodies, and citizens has proven beneficial. The book is also supported by an online infrastructure, UBORA, through which open-source medical devices can be collaboratively developed and shared for the democratization of medical technology and for promoting accessible biomedical engineering education.
