The Design And Manufacture Of Medical Devices

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The Design and Manufacture of Medical Devices

J Paulo Davim
The Design and Manufacture of Medical Devices Book PDF

Author : J Paulo Davim
Publisher : Elsevier
Page : 386 pages
File Size : 50,7 Mb
Release : 2012-10-16
Category : Medical
ISBN : 9781908818188

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The Design and Manufacture of Medical Devices by J Paulo Davim Pdf

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

Reliable Design of Medical Devices

Richard C. Fries
Reliable Design of Medical Devices Book PDF

Author : Richard C. Fries
Publisher : CRC Press
Page : 490 pages
File Size : 50,5 Mb
Release : 2005-11-21
Category : Medical
ISBN : 9781420027945

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Reliable Design of Medical Devices by Richard C. Fries Pdf

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.

Medical Device Design

Anonim
Medical Device Design Book PDF

Author : Anonim
Publisher : Academic Press
Page : 369 pages
File Size : 41,8 Mb
Release : 2012-12-17
Category : Technology & Engineering
ISBN : 9780123919434

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Medical Device Design by Anonim Pdf

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

Biomedical Devices

Tugrul Özel,Paolo Jorge Bártolo,Elisabetta Ceretti,Joaquim De Ciurana Gay,Ciro Angel Rodriguez,Jorge Vicente Lopes Da Silva
Biomedical Devices Book PDF

Author : Tugrul Özel,Paolo Jorge Bártolo,Elisabetta Ceretti,Joaquim De Ciurana Gay,Ciro Angel Rodriguez,Jorge Vicente Lopes Da Silva
Publisher : John Wiley & Sons
Page : 212 pages
File Size : 47,6 Mb
Release : 2016-10-24
Category : Science
ISBN : 9781118478929

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Biomedical Devices by Tugrul Özel,Paolo Jorge Bártolo,Elisabetta Ceretti,Joaquim De Ciurana Gay,Ciro Angel Rodriguez,Jorge Vicente Lopes Da Silva Pdf

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

Design Controls for the Medical Device Industry

Marie B. Teixeira,Richard Bradley
Design Controls for the Medical Device Industry Book PDF

Author : Marie B. Teixeira,Richard Bradley
Publisher : CRC Press
Page : 253 pages
File Size : 43,9 Mb
Release : 2002-09-20
Category : Medical
ISBN : 9780824743550

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Design Controls for the Medical Device Industry by Marie B. Teixeira,Richard Bradley Pdf

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.

Design Control and Manufacture of Medical Devices for Engineers

Priscilla Browne
Design Control and Manufacture of Medical Devices for Engineers Book PDF

Author : Priscilla Browne
Publisher : Independently Published
Page : 102 pages
File Size : 46,9 Mb
Release : 2019-03-17
Category : Technology & Engineering
ISBN : 1090217781

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Design Control and Manufacture of Medical Devices for Engineers by Priscilla Browne Pdf

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)

Design of Biomedical Devices and Systems Second edition

Paul H. King,Richard C. Fries
Design of Biomedical Devices and Systems Second edition Book PDF

Author : Paul H. King,Richard C. Fries
Publisher : CRC Press
Page : 424 pages
File Size : 54,7 Mb
Release : 2008-08-22
Category : Medical
ISBN : 9781439878071

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Design of Biomedical Devices and Systems Second edition by Paul H. King,Richard C. Fries Pdf

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

Medical Device and Equipment Design

Michael E. Wiklund
Medical Device and Equipment Design Book PDF

Author : Michael E. Wiklund
Publisher : CRC Press
Page : 402 pages
File Size : 42,7 Mb
Release : 1995-02-15
Category : Technology & Engineering
ISBN : 0935184694

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Medical Device and Equipment Design by Michael E. Wiklund Pdf

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.

Plastics in Medical Devices

Vinny R. Sastri
Plastics in Medical Devices Book PDF

Author : Vinny R. Sastri
Publisher : Elsevier
Page : 289 pages
File Size : 48,9 Mb
Release : 2010-03-05
Category : Technology & Engineering
ISBN : 9780815520283

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Plastics in Medical Devices by Vinny R. Sastri Pdf

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.

Medical Device Design for Six Sigma

Basem El-Haik,Khalid S. Mekki
Medical Device Design for Six Sigma Book PDF

Author : Basem El-Haik,Khalid S. Mekki
Publisher : John Wiley & Sons
Page : 528 pages
File Size : 53,6 Mb
Release : 2011-09-20
Category : Medical
ISBN : 9781118210413

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Medical Device Design for Six Sigma by Basem El-Haik,Khalid S. Mekki Pdf

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. Comprehensive and complete with real-world examples, thisguide: Integrates concept and design methods such as Pugh ControlledConvergence approach, QFD methodology, parameter optimizationtechniques like Design of Experiment (DOE), Taguchi Robust Designmethod, Failure Mode and Effects Analysis (FMEA), Design for X,Multi-Level Hierarchical Design methodology, and Response Surfacemethodology Covers contemporary and emerging design methods, includingAxiomatic Design Principles, Theory of Inventive Problem Solving(TRIZ), and Tolerance Design Provides a detailed, step-by-step implementation process foreach DFSS tool included Covers the structural, organizational, and technical deploymentof DFSS within the medical device industry Includes a DFSS case study describing the development of a newdevice Presents a global prospective of medical device regulations Providing both a road map and a toolbox, this is a hands-onreference for medical device product development practitioners,product/service development engineers and architects, DFSS and SixSigma trainees and trainers, middle management, engineering teamleaders, quality engineers and quality consultants, and graduatestudents in biomedical engineering.

Six Sigma for Medical Device Design

Jose Justiniano,Venky Gopalaswamy
Six Sigma for Medical Device Design Book PDF

Author : Jose Justiniano,Venky Gopalaswamy
Publisher : CRC Press
Page : 113 pages
File Size : 47,5 Mb
Release : 2004-11-15
Category : Science
ISBN : 9781135506742

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Six Sigma for Medical Device Design by Jose Justiniano,Venky Gopalaswamy Pdf

Six Sigma for Medical Device Design is the first book to apply Six Sigma principles to the design of medical devices. Authored by experienced professionals, it uses real world examples and sample plans to provide a practical how-to guide for implementation. This volume also links the Six Sigma philosophy with the FDA's Design Control and ISO regulations, useful for companies that must be compliant as well as for those in the process of implementing a quality system for design control. This book is an excellent tool for technical and scientific personnel to understand the realities of business and markets, to comply with stringent quality and safety standards, and to optimize the product realization process.

Biomaterials in the Design and Reliability of Medical Devices

Michael N. Helmus
Biomaterials in the Design and Reliability of Medical Devices Book PDF

Author : Michael N. Helmus
Publisher : Springer Science & Business Media
Page : 240 pages
File Size : 54,6 Mb
Release : 2003-01-31
Category : Technology & Engineering
ISBN : 0306476908

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Biomaterials in the Design and Reliability of Medical Devices by Michael N. Helmus Pdf

This book highlights the responsibility of medical device designers and engineers to eliminate sites of failure and to test devices to demonstrate their ultimate safety and efficacy. It also evaluates biomaterials and their properties as related to the design and reliability of medical devices. The principles that are described are readily applicable to the biomaterial scaffolds used for generating tissue-engineered constructs.

Trends in Development of Medical Devices

Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam
Trends in Development of Medical Devices Book PDF

Author : Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam
Publisher : Academic Press
Page : 218 pages
File Size : 44,7 Mb
Release : 2020-01-25
Category : Technology & Engineering
ISBN : 9780128209615

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Trends in Development of Medical Devices by Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam Pdf

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 book useful. The book's editors and contributors form a global, interdisciplinary base of knowledge which they bring to this book. Provides a roadmap to medical devices development and the integration of manufacturing steps to improve workflows Helps engineers in medical devices industries to anticipate the special requirements of this field with relation to biocompatibility, sterilization methods, government regulations Presents new strategies that readers can use to take advantage of rapid prototyping technologies, such as 3D printing, to reduce imperfections in production and develop products that enable completely new treatment possibilities

Medical Device Regulations

Michael Cheng,World Health Organization
Medical Device Regulations Book PDF

Author : Michael Cheng,World Health Organization
Publisher : World Health Organization
Page : 54 pages
File Size : 45,9 Mb
Release : 2003-09-16
Category : Medical
ISBN : 9789241546188

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Medical Device Regulations by Michael Cheng,World Health Organization Pdf

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.

Handbook of Human Factors in Medical Device Design

Matthew Bret Weinger,Michael E. Wiklund,Daryle Jean Gardner-Bonneau
Handbook of Human Factors in Medical Device Design Book PDF

Author : Matthew Bret Weinger,Michael E. Wiklund,Daryle Jean Gardner-Bonneau
Publisher : CRC Press
Page : 844 pages
File Size : 40,9 Mb
Release : 2010-12-13
Category : Technology & Engineering
ISBN : 9781420063516

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Handbook of Human Factors in Medical Device Design by Matthew Bret Weinger,Michael E. Wiklund,Daryle Jean Gardner-Bonneau Pdf

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