The Design and Manufacture of Medical Devices PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download The Design and Manufacture of Medical Devices PDF full book. Access full book title The Design and Manufacture of Medical Devices by J. Paulo Davim. Download full books in PDF and EPUB format.
Author: J. Paulo Davim
Publisher: Elsevier
ISBN: 1908818182
Category : Technology & Engineering
Languages : en
Pages : 382
Get Book Here
Book Description
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
Author: J. Paulo Davim
Publisher: Elsevier
ISBN: 1908818182
Category : Technology & Engineering
Languages : en
Pages : 382
Get Book Here
Book Description
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
Author: Michael Cheng
Publisher: World Health Organization
ISBN: 9241546182
Category : Medical
Languages : en
Pages : 54
Get Book Here
Book Description
The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
Author: Raymond H. W. Lam
Publisher: Springer
ISBN: 3030242374
Category : Medical
Languages : en
Pages : 388
Get Book Here
Book Description
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
Author: Vinny R. Sastri
Publisher: Elsevier
ISBN: 081552028X
Category : Technology & Engineering
Languages : en
Pages : 289
Get Book Here
Book Description
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.
Author: Jean-Pierre Boutrand
Publisher: Woodhead Publishing
ISBN: 0081026447
Category : Technology & Engineering
Languages : en
Pages : 592
Get Book Here
Book Description
Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies. - Presents diverse insights from experts in government, industry and academia - Delivers a comprehensive overview of testing and interpreting medical device performance - Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318
Get Book Here
Book Description
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.
Author: Mary Beth Privitera
Publisher: Academic Press
ISBN: 0128018747
Category : Technology & Engineering
Languages : en
Pages : 307
Get Book Here
Book Description
Contextual Inquiry for Medical Device Design helps users understand the everyday use of medical devices and the way their usage supports the development of better products and increased market acceptance. The text explains the concept of contextual inquiry using real-life examples to illustrate its application. Case studies provide a frame of reference on how contextual inquiry is successfully used during product design, ultimately producing safer, improved medical devices. - Presents the ways contextual inquiry can be used to inform the evaluation and business case of technology - Helps users understand the everyday use of medical devices and the way their usage supports the development of better products - Includes case studies that provide a frame of reference on how contextual inquiry is successfully used during the product design process
Author: Y N Zhou
Publisher: Elsevier
ISBN: 0857096427
Category : Medical
Languages : en
Pages : 583
Get Book Here
Book Description
As medical devices become more intricate, with an increasing number of components made from a wide range of materials, it is important that they meet stringent requirements to ensure that they are safe to be implanted and will not be rejected by the human body. Joining and assembly of medical materials and devices provides a comprehensive overview of joining techniques for a range of medical materials and applications.Part one provides an introduction to medical devices and joining methods with further specific chapters on microwelding methods in medical components and the effects of sterilization on medical materials and welded devices. Part two focuses on medical metals and includes chapters on the joining of shape memory alloys, platinum (Pt) alloys and stainless steel wires for implantable medical devices and evaluating the corrosion performance of metal medical device welds. Part three moves on to highlight the joining and assembly of medical plastics and discusses techniques including ultrasonic welding, transmission laser welding and radio frequency (RF)/dielectric welding. Finally, part four discusses the joining and assembly of biomaterial and tissue implants including metal-ceramic joining techniques for orthopaedic applications and tissue adhesives and sealants for surgical applications.Joining and assembly of medical materials and devices is a technical guide for engineers and researchers within the medical industry, professionals requiring an understanding of joining and assembly techniques in a medical setting, and academics interested in this field. - Introduces joining methods in medical applications including microwelding and considers the effects of sterilization on the resulting joints and devices - Considers the joining, assembly and corrosion performance of medical metals including shape memory alloys, platinum alloys and stainless steel wires - Considers the joining and assembly of medical plastics including multiple welding methods, bonding strategies and adhesives
Author: Tugrul Özel
Publisher: John Wiley & Sons
ISBN: 1118478924
Category : Science
Languages : en
Pages : 212
Get Book Here
Book Description
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
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442
Get Book Here
Book Description
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.
