Download or read book The Design and Manufacture of Medical Devices written by J. Paulo Davim and published by Elsevier. This book was released on 2012-10-16 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices play an important role in the field of medical and health technology, and encompass a wide range of health care products. Directive 2007/47/EC defines a medical device as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings. The design and manufacture of medical devices brings together a range of articles and case studies dealing with medical device R&D. Chapters in the book cover materials used in medical implants, such as Titanium Oxide, polyurethane, and advanced polymers; devices for specific applications such as spinal and craniofacial implants, and other issues related to medical devices, such as precision machining and integrated telemedicine systems. Contains articles on a diverse range of subjects within the field, with internationally renowned specialists discussing each medical device Offers a practical approach to recent developments in the design and manufacture of medical devices Presents a topic that is the focus of research in many important universities and centres of research worldwide

Download or read book Medical Device Design written by and published by Academic Press. This book was released on 2012-12-17 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Design Controls for the Medical Device Industry written by Marie B. Teixeira and published by CRC Press. This book was released on 2002-09-20 with total page 253 pages. Available in PDF, EPUB and Kindle. Book excerpt: This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Details procedures utilized by leading companies to successfully meet FDA and end-user requirements, manufacture high-quality products, and improve and generate profit. Design Controls for the Medical Device Industry contains valuable guidelines that enable readers to prepare for an FDA audit identify consumer needs, resolve project objectives, and process inconsistencies and discrepancies determine the compatibility of design specifications and manufacturing, installation, and servicing demands ensure that proper design, function, and performance stipulations are understood and met verify and validate design criteria and production schemes eliminate confusion and prevent communication breakdowns allocate and conserve resources perform risk assessment analyses predict potential hazards under normal and fault conditions Presenting blueprints for the application, evaluation, and refinement of quality assurance and performance practices-from product launch through engineering and assembly-Design Controls for the Medical Device Industry is a clear and indispensable source for biomedical, quality assurance, reliability, software, product design, manufacturing, research and development, and industrial engineers; project directors and managers; biomedical technicians; and upper-level undergraduate and graduate students in these disciplines.

Download or read book Biomedical Devices written by Tugrul Özel and published by John Wiley & Sons. This book was released on 2016-10-24 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomedical Devices: Design, Prototyping, and Manufacturing features fundamental discussions of all facets of materials processing and manufacturing processes across a wide range of medical devices and artificial tissues. Represents the first compilation of information on the design, prototyping, and manufacture of medical devices into one volume Offers in-depth coverage of medical devices, beginning with an introductory overview through to the design, manufacture, and applications Features examples of a variety of medical applications of devices, including biopsy micro forceps, micro-needle arrays, wrist implants, spinal spacers, and fixtures Provides students, doctors, scientists, and technicians interested in the development and applications of medical devices the ideal reference source

Download or read book Technological Innovation written by Annetine C. Gelijns and published by National Academies. This book was released on 1989 with total page 78 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Reliable Design of Medical Devices written by Richard C. Fries and published by CRC Press. This book was released on 2005-11-21 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.

Download or read book Medical Device and Equipment Design written by Michael E. Wiklund and published by CRC Press. This book was released on 1995-02-15 with total page 402 pages. Available in PDF, EPUB and Kindle. Book excerpt: The key to profitability and success in both the medical device and the equipment markets often relates to how easy your products are to use. User acceptance and preference frequently is dependent upon ergonomic design. Medical Device and Equipment Design helps you enhance your product design, maximize user acceptance, and minimize potential problems in the marketplace. It provides practical guidance on how to plan and incorporate ergonomic design principles into medical devices and equipment so users intuitively feel comfortable with the product. Design engineers, usability and reliability engineers, software programmers, documentation specialists, product managers, quality engineers, and market/product managers will find this text invaluable in getting usability built into products from the very beginning.

Download or read book Biomedical Devices written by Raymond H. W. Lam and published by Springer. This book was released on 2019-08-16 with total page 379 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook provides essential knowledge for biomedical product development, including material properties, fabrication processes and design techniques for different applications, as well as process design and optimization. This book is multidisciplinary and readers can learn techniques to apply acquired knowledge for various applications of biomedical design. Further, this book encourages readers to discover and convert newly reported technologies into products and services for the future development of biomedical applications. This is an ideal book for upper-level undergraduate and graduate students, engineers, technologists, and researchers working in the area of biomedical engineering and manufacturing. This book also: Provides a comprehensive set of fundamental knowledge for engineering students and entry level engineers to design biomedical devices Offers a unique approach to manufacturing of biomedical devices by integrating and formulating different considerations in process design tasks into optimization problems Provides a broad range of application examples to guide readers through the thinking process of designing and manufacturing biomedical devices, from basic understanding about the requirements and regulations to a set of manufacturing parameters

Download or read book Design Control and Manufacture of Medical Devices for Engineers written by Priscilla Browne and published by Independently Published. This book was released on 2019-03-17 with total page 102 pages. Available in PDF, EPUB and Kindle. Book excerpt: The aim of the short book is to provide an understanding of the importance of design controls in device quality and safety for the patient and end user. Design controls interact with main elements of a companies quality management system and they have a continual role in post market surveillance and maintaining the product design throughout its lifecycle. Design Control and their statutory regulations ensure that good quality management (QM) practices are used for the design of medical devices and products remain consistent with quality management systemsDesign controls increase the probability that the design transferred to production will result in a medical device that performs and functions as intended and meets the user's needs. Providing a safe and effective medical device is critical for the success of any firm or manufacturing company. This book covers the nine main areas of design control listed below. It is an ideal desktop companion or resource for those new to design controls or those impacted by them. Short Concise (Paperback book- 99 pages)

Download or read book Medical Device Design and Regulation written by Carl T. DeMarco and published by Quality Press. This book was released on 2011-01-24 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, nonclinical testing, clinical testing, marketing applications, post-market requirements, quality systems/GMPs, and compliance/enforcement. This book provides students and professionals in the medical device industry with a road map to the regulation of medical devices. It provides a broad understanding of the breadth and depth of medical device regulation by collecting in one textbook coverage of the regulatory scheme for medical devices in terms that are suitable for engineers, scientists, and healthcare providers. The vast amount of information available on the subject is distilled into a concise and coherent presentation. There also are problems and projects at the end of each chapter. In addition to the usual questions requiring specific answers, the projects include the drafting of a device control plan, the development of a nonclinical test procedure, the resolution of a recall, the response to a Warning Letter, and the creation of a CAPA for a device deficiency. A solutions manual for these exercises is available to teachers who adopt the textbook for classroom use or for employee training. Medical Device Design and Regulation (MDDR) also makes available over 100 complimentary live hyperlinks to web pages with additional relevant information, and offers users the opportunity to join and participate in the “MDDR Users Group” on LinkedIn.

Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Download or read book Design of Biomedical Devices and Systems Second edition written by Paul H. King and published by CRC Press. This book was released on 2008-08-22 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: The design and functional complexity of medical devices and systems has increased during the past half century, evolving from the level of cardiac pacemakers to magnetic resonance imaging devices. Such life-saving advancements are monumentally advantageous, but with so much at stake, a step-by-step manual for biomedical engineers is essential. This

Download or read book Designing and Developing Medical Devices written by Martin and published by . This book was released on 2023-12 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Understanding the Role of Manufacturing Engineering in Medical Device DevelopmentManufacturing engineering plays a critical role in the development of medical devices, ensuring that these life-saving technologies are not only safe and effective but also cost-efficient and scalable. This subchapter aims to provide students studying manufacturing engineering with a comprehensive understanding of their role in the medical device development process. The field of manufacturing engineering focuses on the design, development, and implementation of efficient manufacturing processes and systems. When it comes to medical device development, manufacturing engineers are responsible for translating the design concept into a tangible product that can be mass-produced. One of the key responsibilities of manufacturing engineers is to optimize the manufacturing process to meet the specific requirements of medical device production. This involves selecting appropriate materials, designing efficient assembly lines, and ensuring that the manufacturing process adheres to regulatory standards such as Good Manufacturing Practices (GMP) and ISO 13485. Manufacturing engineers also collaborate closely with design engineers to ensure that the product design is manufacturable. They provide valuable input during the design phase, offering insights into material selection, component sourcing, and production feasibility. By working together, manufacturing engineers and design engineers can create a product that not only meets the functional requirements but is also easy to manufacture. Another crucial aspect of manufacturing engineering in medical device development is quality control. Manufacturing engineers are responsible for developing and implementing quality control processes to ensure that each device meets the highest standards of safety and effectiveness. This involves conducting thorough inspections, tests, and certifications throughout the manufacturing process. Furthermore, manufacturing engineers play a vital role in ensuring cost-effectiveness and scalability of medical device production. They are responsible for identifying areas where costs can be reduced without compromising the quality of the product. They also develop strategies to scale up production to meet increasing demand while maintaining efficiency and quality.

Download or read book Reliable Design of Medical Devices Third Edition written by Richard C. Fries and published by CRC Press. This book was released on 2012-09-06 with total page 505 pages. Available in PDF, EPUB and Kindle. Book excerpt: As medical devices become even more intricate, concerns about efficacy, safety, and reliability continue to be raised. Users and patients both want the device to operate as specified, perform in a safe manner, and continue to perform over a long period of time without failure. Following in the footsteps of the bestselling second edition, Reliable Design of Medical Devices, Third Edition shows you how to improve reliability in the design of advanced medical devices. Reliability engineering is an integral part of the product development process and of problem-solving activities related to manufacturing and field failures. Mirroring the typical product development process, the book is organized into seven parts. After an introduction to the basics of reliability engineering and failures, it takes you through the concept, feasibility, design, verification and validation, design transfer and manufacturing, and field activity phases. Topics covered include Six Sigma for design, human factors, safety and risk analysis, and new techniques such as accelerated life testing (ALT) and highly accelerated life testing (HALT). What’s New in This Edition Updates throughout, reflecting changes in the field An updated software development process Updated hardware test procedures A new layout that follows the product development process A list of deliverables needed at the end of each development phase Incorporating reliability engineering as a fundamental design philosophy, this book shares valuable insight from the author’s more than 35 years of experience. A practical guide, it helps you develop a more effective reliability engineering program—contributing to increased profitability, more satisfied customers, and less risk of liability.

Download or read book Plastics in Medical Devices written by Vinny R. Sastri and published by Elsevier. This book was released on 2010-03-05 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.

Download or read book Medical Devices and the Public s Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

Download or read book Public Health Effectiveness of the FDA 510 k Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.