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

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  • Author : J Paulo Davim
  • Publisher : Elsevier
  • Pages : 386 pages
  • ISBN : 1908818182
  • 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 : 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

Biomedical Devices

Biomedical Devices
  • Author : Tŭgrul ?zel,Paolo Jorge B?rtolo,Elisabetta Ceretti,Joaquim De Ciurana Gay,Ciro Angel Rodriguez,Jorge Vicente Lopes Da Silva
  • Publisher : John Wiley & Sons
  • Release : 24 October 2016
GET THIS BOOKBiomedical Devices

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,

Trends in Development of Medical Devices

Trends in Development of Medical Devices
  • Author : Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam
  • Publisher : Academic Press
  • Release : 25 January 2020
GET THIS BOOKTrends in Development of Medical Devices

Trends in Development of Medical Devices covers the basics of medical devices and their development, regulations and toxicological effects, risk assessment and mitigation. It also discusses the maintenance of a medical device portfolio during product lifecycle. This book provides up-to-date information and knowledge on how to understand the position and benefits of new introduced medical devices for improving healthcare. Researchers and industry professionals from the fields of medical devices, surgery, medical toxicology, pharmacy and medical devices manufacture will find this

Applied Human Factors in Medical Device Design

Applied Human Factors in Medical Device Design
  • Author : Mary Beth Privitera
  • Publisher : Academic Press
  • Release : 15 June 2019
GET THIS BOOKApplied Human Factors in Medical Device Design

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 Controls for the Medical Device Industry

Design Controls for the Medical Device Industry
  • Author : Marie Teixeira,Richard Bradley
  • Publisher : CRC Press
  • Release : 20 September 2002
GET THIS BOOKDesign Controls for the Medical Device Industry

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

Medical Devices

Medical Devices
  • Author : Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
  • Publisher : Woodhead Publishing
  • Release : 18 August 2015
GET THIS BOOKMedical Devices

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 of Medical Electronic Devices

Design of Medical Electronic Devices
  • Author : Reinaldo Perez
  • Publisher : Elsevier
  • Release : 21 March 2002
GET THIS BOOKDesign of Medical Electronic Devices

The design of medical electronics is unique because of the background needed by the engineers and scientists involved. Often the designer is a medical or life science professional without any training in electronics or design. Likewise, few engineers are specifically trained in biomedical engineering and have little or no exposure to the specific medical requirements of these devices. Design of Medical Electronic Devices presents all essential topics necessary for basic and advanced design. All aspects of the electronics of medical

Plastics in Medical Devices

Plastics in Medical Devices
  • Author : Vinny R. Sastri
  • Publisher : Elsevier
  • Release : 05 March 2010
GET THIS BOOKPlastics in Medical Devices

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

Medical Device Design for Six Sigma

Medical Device Design for Six Sigma
  • Author : Basem El-Haik,Khalid S. Mekki
  • Publisher : John Wiley & Sons
  • Release : 20 September 2011
GET THIS BOOKMedical Device Design for Six Sigma

The first comprehensive guide to the integration of Design forSix Sigma principles in the medical devices development cycle Medical Device Design for Six Sigma: A Road Map for Safetyand Effectiveness presents the complete body of knowledge forDesign for Six Sigma (DFSS), as outlined by American Society forQuality, and details how to integrate appropriate designmethodologies up front in the design process. DFSS helps companiesshorten lead times, cut development and manufacturing costs, lowertotal life-cycle cost, and improve the quality of the medicaldevices.

Handbook on Advanced Design and Manufacturing Technologies for Biomedical Devices

Handbook on Advanced Design and Manufacturing Technologies for Biomedical Devices
  • Author : Andrés Díaz Lantada
  • Publisher : Springer Science & Business Media
  • Release : 08 July 2014
GET THIS BOOKHandbook on Advanced Design and Manufacturing Technologies for Biomedical Devices

​The last decades have seen remarkable advances in computer‐aided design, engineering and manufacturing technologies, multi‐variable simulation tools, medical imaging, biomimetic design, rapid prototyping, micro and nanomanufacturing methods and information management resources, all of which provide new horizons for the Biomedical Engineering fields and the Medical Device Industry. Advanced Design and Manufacturing Technologies for Biomedical Devices covers such topics in depth, with an applied perspective and providing several case studies that help to analyze and understand the key factors

Pharmaceutical Dosage Forms

Pharmaceutical Dosage Forms
  • Author : Kenneth E. Avis
  • Publisher : Routledge
  • Release : 04 May 2018
GET THIS BOOKPharmaceutical Dosage Forms

Completely updated and enlarged to three volumes (originally published as two volumes), the Second Edition of Pharmaceutical Dosage Forms: Parenteral Medications examines every important aspect of sterile drug products. This volume (3) offers comprehensive coverage of medical devices, quality assurance and regulatory issues.;This in-depth reference and text: discusses regulatory requirements in record-keeping based on the US Food and Drug Administration's (FDA) Current Good Manufacturing Practices; places special emphasis on methods of detecting, counting and sizing particles; offers new perspectives on

Metallic Biomaterials Processing and Medical Device Manufacturing

Metallic Biomaterials Processing and Medical Device Manufacturing
  • Author : Cuie Wen
  • Publisher : Woodhead Publishing
  • Release : 20 August 2020
GET THIS BOOKMetallic Biomaterials Processing and Medical Device Manufacturing

Metallic Biomaterials Processing and Medical Device Manufacturing details the principles and practices of the technologies used in biomaterials processing and medical device manufacturing. The book reviews the main categories of metallic biomaterials and the essential considerations in design and manufacturing of medical devices. It bridges the gap between the designing of biomaterials and manufacturing of medical devices including requirements and standards. Main themes of the book include, manufacturing, coatings and surface modifications of medical devices, metallic biomaterials and their mechanical

Usability Testing of Medical Devices

Usability Testing of Medical Devices
  • Author : Michael E. Wiklund P.E.,Jonathan Kendler,Allison Y. Strochlic
  • Publisher : CRC Press
  • Release : 23 December 2015
GET THIS BOOKUsability Testing of Medical Devices

Usability Testing of Medical Devices covers the nitty-gritty of usability test planning, conducting, and results reporting. The book also discusses the government regulations and industry standards that motivate many medical device manufacturers to conduct usability tests.Since publication of the first edition, the FDA and other regulatory groups h

Biomedical Devices

Biomedical Devices
  • Author : Raymond H. W. Lam,Weiqiang Chen
  • Publisher : Springer
  • Release : 16 August 2019
GET THIS BOOKBiomedical Devices

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,