The Design and Manufacture of Medical Devices

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

Produk Detail:

  • Author : J. Paulo Davim
  • Publisher : Woodhead Pub Limited
  • Pages : 339 pages
  • ISBN : 9781907568725
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKThe Design and Manufacture of Medical Devices

The Design and Manufacture of Medical Devices

The Design and Manufacture of Medical Devices
  • Author : J. Paulo Davim
  • Publisher : Woodhead Pub Limited
  • Release : 20 September 2021
GET THIS BOOKThe Design and Manufacture of Medical Devices

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

The Design and Manufacture of Medical Devices

The Design and Manufacture of Medical Devices
  • Author : J Paulo Davim
  • Publisher : Elsevier
  • Release : 16 October 2012
GET THIS BOOKThe Design and Manufacture of Medical Devices

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

Medical Device Design

Medical Device Design
  • Author : Peter J Ogrodnik
  • Publisher : Academic Press
  • Release : 17 December 2012
GET THIS BOOKMedical Device Design

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

Design and Development of Medical Electronic Instrumentation

Design and Development of Medical Electronic Instrumentation
  • Author : David Prutchi,Michael Norris
  • Publisher : John Wiley & Sons
  • Release : 28 January 2005
GET THIS BOOKDesign and Development of Medical Electronic Instrumentation

Design and Development of Medical Electronic Instrumentation fills a gap in the existing medical electronic devices literature by providing background and examples of how medical instrumentation is actually designed and tested. The book includes practical examples and projects, including working schematics, ranging in difficulty from simple biopotential amplifiers to computer-controlled defibrillators. Covering every stage of the development process, the book provides complete coverage of the practical aspects of amplifying, processing, simulating and evoking biopotentials. In addition, two chapters address the

Reliable Design of Medical Devices, Third Edition

Reliable Design of Medical Devices, Third Edition
  • Author : Richard C. Fries
  • Publisher : CRC Press
  • Release : 06 September 2012
GET THIS BOOKReliable Design of Medical Devices, Third Edition

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

Philosophy and Engineering

Philosophy and Engineering
  • Author : Diane P. Michelfelder,Byron Newberry,Qin Zhu
  • Publisher : Springer
  • Release : 26 November 2016
GET THIS BOOKPhilosophy and Engineering

This volume, the result of an ongoing bridge building effort among engineers and humanists, addresses a variety of philosophical, ethical, and policy issues emanating from engineering and technology. Interwoven through its chapters are two themes, often held in tension with one another: “Exploring Boundaries” and “Expanding Connections.” “Expanding Connections” highlights contributions that look to philosophy for insight into some of the challenges engineers face in working with policy makers, lay designers, and other members of the public. It also speaks

Medical Product Regulatory Affairs

Medical Product Regulatory Affairs
  • Author : John J. Tobin,Gary Walsh
  • Publisher : John Wiley & Sons
  • Release : 24 August 2011
GET THIS BOOKMedical Product Regulatory Affairs

Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/

Handbook of Medical Device Design

Handbook of Medical Device Design
  • Author : Richard C. Fries
  • Publisher : CRC Press
  • Release : 14 September 2000
GET THIS BOOKHandbook of Medical Device Design

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

Medical Devices

Medical Devices
  • Author : United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Public Health and Environment
  • Publisher : Unknown Publisher
  • Release : 20 September 1974
GET THIS BOOKMedical Devices

Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation

Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation
  • Author : Orlando Lopez
  • Publisher : Taylor & Francis
  • Release : 02 October 2018
GET THIS BOOKPharmaceutical and Medical Devices Manufacturing Computer Systems Validation

Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements. Compliance is a state of