Author : Richard C. Fries
Publisher : CRC Press
Page : 795 pages
File Size : 21,57 MB
Release : 2019-08-15
Category : Technology & Engineering
ISBN : 1000693872
First published in 2001: This handbook has been written to give those professionals working in the development and use of medical devices practical knowledge about biomedical technology, regulations, and their relationship to quality health care.
Author : Matthew Bret Weinger
Publisher : CRC Press
Page : 822 pages
File Size : 21,39 MB
Release : 2010-12-13
Category : Technology & Engineering
ISBN : 1420063510
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
Author :
Publisher : Academic Press
Page : 369 pages
File Size : 16,44 MB
Release : 2012-12-17
Category : Technology & Engineering
ISBN : 0123919436
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
Author : Richard C. Fries
Publisher : CRC Press
Page : 798 pages
File Size : 38,24 MB
Release : 2000-09-14
Category : Medical
ISBN : 9780824703998
The Handbook of Medical Device Design provides a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives. It identifies how to determine and document customer needs and device requirements. It also establishes reliability and quality metrics for the duration of the product development cycle. Topics include
Author : Theodore R. Kucklick
Publisher : CRC Press
Page : 376 pages
File Size : 16,84 MB
Release : 2005-11-21
Category : Medical
ISBN : 1420038354
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 Ha
Author : Marie Teixeira
Publisher : CRC Press
Page : 258 pages
File Size : 16,66 MB
Release : 2002-09-20
Category : Medical
ISBN : 9780203909386
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 utilize
Author : Mary Beth Privitera
Publisher : Academic Press
Page : 371 pages
File Size : 31,38 MB
Release : 2019-06-15
Category : Science
ISBN : 0128161647
Applied Human Factors in Medical Device Design describes the contents of a human factors toolbox with in-depth descriptions of both empirical and analytical methodologies. The book begins with an overview of the design control process, integrating human factors as directed by AAMI TIR 59 and experienced practice. It then explains each method, describing why each method is important, its potential impact, when it's ideal to use, and related challenges. Also discussed are other barriers, such as communication breakdowns between users and design teams. This book is an excellent reference for professionals working in human factors, design, engineering, marketing and regulation. - Focuses on meeting agency requirements as it pertains to the application of human factors in the medical device development process in both the US and the European Union (EU) - Explains technology development and the application of human factors throughout the development process - Covers FDA and MHRA regulations - Includes case examples with each method
Author : Seeram Ramakrishna
Publisher : Woodhead Publishing
Page : 253 pages
File Size : 45,16 MB
Release : 2015-08-18
Category : Medical
ISBN : 0081002912
Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. - Provides readers with a global perspective on medical device regulations - Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards - Includes a useful case study demonstrating the design and approval process
Author : Joseph F. Dyro
Publisher : Academic Press
Page : 696 pages
File Size : 10,65 MB
Release : 2004-08-27
Category : Medical
ISBN : 012226570X
As the biomedical engineering field expands throughout the world, clinical engineers play an ever more important role as the translator between the worlds of the medical, engineering, and business professionals. They influence procedure and policy at research facilities, universities and private and government agencies including the Food and Drug Administration and the World Health Organization. Clinical engineers were key players in calming the hysteria over electrical safety in the 1970s and Y2K at the turn of the century and continue to work for medical safety. This title brings together all the important aspects of Clinical Engineering. It provides the reader with prospects for the future of clinical engineering as well as guidelines and standards for best practice around the world.
Author : Sina Ebnesajjad
Publisher : Elsevier Inc. Chapters
Page : 61 pages
File Size : 30,62 MB
Release : 2013-12-05
Category : Technology & Engineering
ISBN : 0128076682
This chapter focuses on adhesives used in direct physiological contact in dental and medical procedures. Activity in both areas has been quite extensive outside the United States for decades. In contrast, adhesive use in medical devices, patches, and plasters has been ongoing in the United States for a long time. In the case of medical devices, adhesion is concerned with the joining of materials such as plastics, elastomers, textiles, metals, and ceramics, which are examined in other chapters of the present volume and are covered in various references [1–6], The coverage of this chapter is devoted to applications where to adhesives are in direct contact with tissues and other live organs.
