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The Design and Manufacture of Medical Devices

The Design and Manufacture of Medical Devices
A Book

by J Paulo Davim

  • Publisher : Elsevier
  • Release : 2012-10-16
  • Pages : 386
  • ISBN : 1908818182
  • Language : En, Es, Fr & De
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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

Design Control and Manufacture of Medical Devices for Engineers

Design Control and Manufacture of Medical Devices for Engineers
A Book

by Priscilla Browne

  • Publisher : Independently Published
  • Release : 2019-03-17
  • Pages : 102
  • ISBN : 9781090217783
  • Language : En, Es, Fr & De
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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)

Medical Device Design

Medical Device Design
Innovation from Concept to Market

by Peter J Ogrodnik

  • Publisher : Academic Press
  • Release : 2012-12-17
  • Pages : 376
  • ISBN : 0123919436
  • Language : En, Es, Fr & De
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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

Biomedical Devices
Materials, Design, and Manufacturing

by Raymond H. W. Lam,Weiqiang Chen

  • Publisher : Springer
  • Release : 2019-08-16
  • Pages : 379
  • ISBN : 3030242374
  • Language : En, Es, Fr & De
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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

Reliable Design of Medical Devices, Third Edition

Reliable Design of Medical Devices, Third Edition
A Book

by Richard C. Fries

  • Publisher : CRC Press
  • Release : 2012-09-06
  • Pages : 501
  • ISBN : 1439894914
  • Language : En, Es, Fr & De
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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 of the product development process and of problem-solving activities related to manufacturing and field failures. Mirroring the typical product development process, the book is organized into seven parts. After an introduction to the basics of reliability engineering and failures, it takes you through the concept, feasibility, design, verification and validation, design transfer and manufacturing, and field activity phases. Topics covered include Six Sigma for design, human factors, safety and risk analysis, and new techniques such as accelerated life testing (ALT) and highly accelerated life testing (HALT). What’s New in This Edition Updates throughout, reflecting changes in the field An updated software development process Updated hardware test procedures A new layout that follows the product development process A list of deliverables needed at the end of each development phase Incorporating reliability engineering as a fundamental design philosophy, this book shares valuable insight from the author’s more than 35 years of experience. A practical guide, it helps you develop a more effective reliability engineering program—contributing to increased profitability, more satisfied customers, and less risk of liability.

Design of Facilities for Manufacture of Medical Devices & Diagnostic Products

Design of Facilities for Manufacture of Medical Devices & Diagnostic Products
A Handbook

by Leroy Leslie Hamilton,G. Briggs Phillips,Lawrence J. Worden

  • Publisher : Unknown Publisher
  • Release : 1978
  • Pages : 257
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Medical Device Design for Six Sigma

Medical Device Design for Six Sigma
A Road Map for Safety and Effectiveness

by Basem El-Haik,Khalid S. Mekki

  • Publisher : John Wiley & Sons
  • Release : 2011-09-20
  • Pages : 528
  • ISBN : 1118210417
  • Language : En, Es, Fr & De
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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.

Manufacturing In The Era Of 4th Industrial Revolution: A World Scientific Reference (In 3 Volumes)

Manufacturing In The Era Of 4th Industrial Revolution: A World Scientific Reference (In 3 Volumes)
A Book

by Anonim

  • Publisher : World Scientific
  • Release : 2021-01-13
  • Pages : 1000
  • ISBN : 9811222800
  • Language : En, Es, Fr & De
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The era of the fourth industrial revolution has fundamentally transformed the manufacturing landscape. Products are getting increasingly complex and customers expect a higher level of customization and quality. Manufacturing in the Era of 4th Industrial Revolution explores three technologies that are the building blocks of the next-generation advanced manufacturing.The first technology covered in Volume 1 is Additive Manufacturing (AM). AM has emerged as a very popular manufacturing process. The most common form of AM is referred to as 'three-dimensional (3D) printing'. Overall, the revolution of additive manufacturing has led to many opportunities in fabricating complex, customized, and novel products. As the number of printable materials increases and AM processes evolve, manufacturing capabilities for future engineering systems will expand rapidly, resulting in a completely new paradigm for solving a myriad of global problems.The second technology is industrial robots, which is covered in Volume 2 on Robotics. Traditionally, industrial robots have been used on mass production lines, where the same manufacturing operation is repeated many times. Recent advances in human-safe industrial robots present an opportunity for creating hybrid work cells, where humans and robots can collaborate in close physical proximities. This Cobots, or collaborative robots, has opened up to opportunity for humans and robots to work more closely together. Recent advances in artificial intelligence are striving to make industrial robots more agile, with the ability to adapt to changing environments and tasks. Additionally, recent advances in force and tactile sensing enable robots to be used in complex manufacturing tasks. These new capabilities are expanding the role of robotics in manufacturing operations and leading to significant growth in the industrial robotics area.The third technology covered in Volume 3 is augmented and virtual reality. Augmented and virtual reality (AR/VR) technologies are being leveraged by the manufacturing community to improve operations in a wide variety of ways. Traditional applications have included operator training and design visualization, with more recent applications including interactive design and manufacturing planning, human and robot interactions, ergonomic analysis, information and knowledge capture, and manufacturing simulation. The advent of low-cost solutions in these areas is accepted to accelerate the rate of adoption of these technologies in the manufacturing and related sectors.Consisting of chapters by leading experts in the world, Manufacturing in the Era of 4th Industrial Revolution provides a reference set for supporting graduate programs in the advanced manufacturing area.

DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS

DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS
A COMPREHENSIVE HANDBOOK FOR INTERPRETING AND IMPLEMENTING DESIGN CONTROL REGULATION

by Vernon Geckler

  • Publisher : Wasatch Consulting Resources LLC
  • Release : 2017-02-11
  • Pages : 441
  • ISBN : 0692835415
  • Language : En, Es, Fr & De
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This handbook provides the most up to date resource currently available for interpreting and understanding design controls. This handbook is the most exhaustive resource ever written about FDA & ISO 13485 design controls for medical devices with a collection of all applicable regulations and real-world examples. Four-hundred & forty, 8.5" X 11" pages provides an extensive evaluation of FDA 21 CFR 820 and is cross-referenced with ISO 13485 to provide readers with a broad and in-depth review of practical design control implementation techniques. This handbook also covers basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading an existing process into medical device quality systems. This critical resource also specifically outlines key topics which will allow quality managers and medical device developers to improve compliance quickly to pass internal and external audits and FDA inspections. The author breaks down the regulation line by line and provides a detailed interpretation by using supportive evidence from the FDA design control guidance and the quality systems preamble. Numerous examples, case studies, best practices, 70+ figures and 45+ tables provide practical implementation techniques which are based on the author's extensive experience launching numerous medical device products and by integrating industry consultant expertise. In addition, bonus chapters include: explanation of medical device classification, compliance to design controls, risk management, and the design control quality system preamble. 20-40 pages are dedicated to each of the major design control topics: Design and Development Planning, Design Input, Design Output, Design Transfer, Design Verification, Design Validation, Design Change and Design History File.

Handbook of Medical Device Design

Handbook of Medical Device Design
A Book

by Richard C. Fries

  • Publisher : CRC Press
  • Release : 2019-08-15
  • Pages : 774
  • ISBN : 1000696952
  • Language : En, Es, Fr & De
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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.

Guide to Good Manufacturing Practice for Medical Equipment

Guide to Good Manufacturing Practice for Medical Equipment
A Book

by Dhss

  • Publisher : Unknown Publisher
  • Release : 1983
  • Pages : 30
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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This guide specifies requirements for a system for the assurance of quality in the design, manufacture and installation of medical equip- ment, and for the purpose of this guide medical equipment is defined as those medical devices relying on a power source of their function. This guide specifies minimum quality system requirements for applica- tion to medical equipment, the technical requirements of which are specified principally in terms of the performance required, or for which the design has not been established.

Design Engineering of Biomaterials for Medical Devices

Design Engineering of Biomaterials for Medical Devices
A Book

by David Hill

  • Publisher : Wiley
  • Release : 1998-09-16
  • Pages : 480
  • ISBN : 9780471967088
  • Language : En, Es, Fr & De
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Written by an exceptionally experienced author in the area of medical equipment product design, this text presents a comprehensive overview of such sound principles and state-of-the-art techniques covering a whole host of material types, biocompatability, the design process and future trends within this exciting field. An all-in-one reference text, concise and easy-to-read. Wide audience appeal, from industry professionals to students of design.

Reliable Design of Medical Devices

Reliable Design of Medical Devices
A Book

by Richard C. Fries

  • Publisher : CRC Press
  • Release : 1997-01-30
  • Pages : 728
  • ISBN : 9781420001013
  • Language : En, Es, Fr & De
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Presenting the basic concepts and major issues associated with medical device design, this text describes current development processes as well as standards and regulatory information, providing a basis for assessing new technologies. It aims to help manufacturers establish and operate a viable reliability assurance programme, and purchasers to formulate effective methods of vendor evaluation.

Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices
A Book

by Bijan Elahi

  • Publisher : Academic Press
  • Release : 2021-11-11
  • Pages : 534
  • ISBN : 0323918239
  • Language : En, Es, Fr & De
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Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs. Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations. Includes new coverage of ISO 14971:2019, ISO/TR 24971 Presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk management Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation

International Medical Device Regulation

International Medical Device Regulation
Europe, USA, Canada, Japan - A Comprehensive Introduction

by Daniel Shoukier

  • Publisher : epubli
  • Release : 2011
  • Pages : 208
  • ISBN : 3844202579
  • Language : En, Es, Fr & De
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New Technology in Thermoplastic Materials, Processes, and Applications for Medical Devices and Packaging

New Technology in Thermoplastic Materials, Processes, and Applications for Medical Devices and Packaging
Medical Design and Manufacturing Regional Technical Conference : Papers

by SPE. Medical Plastics Division

  • Publisher : Unknown Publisher
  • Release : 1995
  • Pages : 129
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Design of Medical Electronic Devices

Design of Medical Electronic Devices
A Book

by Reinaldo Perez

  • Publisher : Academic Press
  • Release : 2002-03-14
  • Pages : 279
  • ISBN : 9780125507110
  • Language : En, Es, Fr & De
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Acknowledgments -- Introduction -- 1 Proper Design of Power Subsystems in Medical Electronics -- 2 Fundamentals of Magnetic Resonance Imaging -- 3 Particle Accelerator Design -- 4 Sensor Characteristics -- 5 Data Acquisition -- 6 Noise and Interference Issues in Analog Circuits -- 7 Hardware Approach to Digital Signal Processing -- 8 Optical Sensors -- Index.

Reliable Design of Medical Devices

Reliable Design of Medical Devices
A Book

by Richard C. Fries

  • Publisher : CRC Press
  • Release : 2016-04-19
  • Pages : 501
  • ISBN : 1439894949
  • Language : En, Es, Fr & De
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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 D

Design Controls for the Medical Device Industry

Design Controls for the Medical Device Industry
A Book

by Marie B. Teixeira,Richard Bradley

  • Publisher : CRC Press
  • Release : 2002-09-20
  • Pages : 254
  • ISBN : 0824743555
  • Language : En, Es, Fr & De
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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.

Medical Product Regulatory Affairs

Medical Product Regulatory Affairs
Pharmaceuticals, Diagnostics, Medical Devices

by John J. Tobin,Gary Walsh

  • Publisher : John Wiley & Sons
  • Release : 2011-08-24
  • Pages : 297
  • ISBN : 3527644717
  • Language : En, Es, Fr & De
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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/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.