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Medical Devices

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Plastics in Medical Devices

Plastics in Medical Devices Book
Author : Vinny R. Sastri
Publisher : Elsevier
Release : 2010-03-05
ISBN : 081552028X
Language : En, Es, Fr & De

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Book Description :

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 Devices

Medical Devices Book
Author : Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
Publisher : Woodhead Publishing
Release : 2015-08-18
ISBN : 0081002912
Language : En, Es, Fr & De

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Book Description :

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

Cybersecurity for Connected Medical Devices

Cybersecurity for Connected Medical Devices Book
Author : Arnab Ray
Publisher : Academic Press
Release : 2021-11-09
ISBN : 0128182636
Language : En, Es, Fr & De

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Book Description :

The cybersecurity of connected medical devices is one of the biggest challenges facing healthcare today. The compromise of a medical device can result in severe consequences for both patient health and patient data. Cybersecurity for Connected Medical Devices covers all aspects of medical device cybersecurity, with a focus on cybersecurity capability development and maintenance, system and software threat modeling, secure design of medical devices, vulnerability management, and integrating cybersecurity design aspects into a medical device manufacturer's Quality Management Systems (QMS). This book is geared towards engineers interested in the medical device cybersecurity space, regulatory, quality, and human resources specialists, and organizational leaders interested in building a medical device cybersecurity program. Lays out clear guidelines for how to build a medical device cybersecurity program through the development of capabilities Discusses different regulatory requirements of cybersecurity and how to incorporate them into a Quality Management System Provides a candidate method for system and software threat modelling Provides an overview of cybersecurity risk management for medical devices Presents technical cybersecurity controls for secure design of medical devices Provides an overview of cybersecurity verification and validation for medical devices Presents an approach to logically structure cybersecurity regulatory submissions

Bringing Medical Devices to Market

Bringing Medical Devices to Market Book
Author : AMERICAN BAR ASSOCIATION.
Publisher : Unknown
Release : 2022-05-02
ISBN : 9781641059701
Language : En, Es, Fr & De

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Book Description :

This book guides readers through the process of bringing a new medical device from proof-of-concept to the market.

Medical Device Design

Medical Device Design Book
Author : Peter J Ogrodnik
Publisher : Academic Press
Release : 2012-12-17
ISBN : 0123919436
Language : En, Es, Fr & De

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Book Description :

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

Energy Efficiency of Medical Devices and Healthcare Applications

Energy Efficiency of Medical Devices and Healthcare Applications Book
Author : Amr Mohamed
Publisher : Academic Press
Release : 2020-02-15
ISBN : 0128190469
Language : En, Es, Fr & De

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Book Description :

Energy Efficiency of Medical Devices and Healthcare Facilities provides comprehensive coverage of cutting-edge, interdisciplinary research, and commercial solutions in this field. The authors discuss energy-related challenges, such as energy-efficient design, including renewable energy, of different medical devices from a hardware and mechanical perspectives, as well as energy management solutions and techniques in healthcare networks and facilities. They also discuss energy-related trade-offs to maximize the medical devices availability, especially battery-operated ones, while providing immediate response and low latency communication in emergency situations, sustainability and robustness for chronic disease treatment, in addition to high protection against cyber-attacks that may threaten patients’ lives. Finally, the book examines technologies and future trends of next generation healthcare from an energy efficiency and management point of view, such as personalized or smart health and the Internet of Medical Things — IoMT, where patients can participate in their own treatment through innovative medical devices and software applications and tools. The books applied approach makes it a useful resource for engineering researchers and practitioners of all levels involved in medical devices development, healthcare systems, and energy management of healthcare facilities. Graduate students in mechanical and electric engineering, and computer science students and professionals also benefit. Provides in-depth knowledge and understanding of the benefits of energy efficiency in the design of medical devices and healthcare networks and facilities Presents best practices and state-of-art techniques and commercial solutions in energy management of healthcare networks and systems Explores key energy tradeoffs to provide scalable, robust, and effective healthcare systems and networks

Medical Device Technologies

Medical Device Technologies Book
Author : Gail D. Baura,Gail Baura
Publisher : Academic Press
Release : 2011-10-07
ISBN : 012374976X
Language : En, Es, Fr & De

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Book Description :

Medical Device Technologies introduces undergraduate engineering students to commonly manufactured medical devices. It is the first textbook that discusses both electrical and mechanical medical devices. The first 20 chapters are medical device technology chapters; the remaining eight chapters focus on medical device laboratory experiments. Each medical device chapter begins with an exposition of appropriate physiology, mathematical modeling or biocompatibility issues, and clinical need. A device system description and system diagram provide details on technology function and administration of diagnosis and/or therapy. The systems approach lets students quickly identify the relationships between devices. Device key features are based on five applicable consensus standard requirements from organizations such as ISO and the Association for the Advancement of Medical Instrumentation (AAMI). The medical devices discussed are Nobel Prize or Lasker Clinical Prize winners, vital signs devices, and devices in high industry growth areas Three significant Food and Drug Administration (FDA) recall case studies which have impacted FDA medical device regulation are included in appropriate device chapters Exercises at the end of each chapter include traditional homework problems, analysis exercises, and four questions from assigned primary literature Eight laboratory experiments are detailed that provide hands-on reinforcement of device concepts

Implantable Electronic Medical Devices

Implantable Electronic Medical Devices Book
Author : Dennis Fitzpatrick
Publisher : Elsevier
Release : 2014-11-05
ISBN : 012416577X
Language : En, Es, Fr & De

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Book Description :

Implantable Electronic Medical Devices provides a thorough review of the application of implantable devices, illustrating the techniques currently being used together with overviews of the latest commercially available medical devices. This book provides an overview of the design of medical devices and is a reference on existing medical devices. The book groups devices with similar functionality into distinct chapters, looking at the latest design ideas and techniques in each area, including retinal implants, glucose biosensors, cochlear implants, pacemakers, electrical stimulation therapy devices, and much more. Implantable Electronic Medical Devices equips the reader with essential background knowledge on the application of existing medical devices as well as providing an introduction to the latest techniques being used. A catalogue of existing implantable electronic medical devices Up-to-date information on the design of implantable electronic medical devices Background information and reviews on the application and design of up-to-date implantable electronic medical devices

Managing Medical Devices within a Regulatory Framework

Managing Medical Devices within a Regulatory Framework Book
Author : Beth Ann Fiedler
Publisher : Elsevier
Release : 2016-09-10
ISBN : 0128041927
Language : En, Es, Fr & De

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Book Description :

Managing Medical Devices within a Regulatory Framework helps administrators, designers, manufacturers, clinical engineers, and biomedical support staff to navigate worldwide regulation, carefully consider the parameters for medical equipment patient safety, anticipate problems with equipment, and efficiently manage medical device acquisition budgets throughout the total product life cycle. This contributed book contains perspectives from industry professionals and academics providing a comprehensive look at health technology management (HTM) best practices for medical records management, interoperability between and among devices outside of healthcare, and the dynamics of implementation of new devices. Various chapters advise on how to achieve patient confidentiality compliance for medical devices and their software, discuss legal issues surrounding device use in the hospital environment of care, the impact of device failures on patient safety, methods to advance skillsets for HTM professionals, and resources to assess digital technology. The authors bring forth relevant challenges and demonstrate how management can foster increased clinical and non-clinical collaboration to enhance patient outcomes and the bottom line by translating the regulatory impact on operational requirements. Covers compliance with FDA and CE regulations, plus EU directives for service and maintenance of medical devices Provides operational and clinical practice recommendations in regard to regulatory changes for risk management Discusses best practices for equipment procurement and maintenance Provides guidance on dealing with the challenge of medical records management and compliance with patient confidentiality using information from medical devices

Joining and Assembly of Medical Materials and Devices

Joining and Assembly of Medical Materials and Devices Book
Author : Y N Zhou,M D Breyen
Publisher : Elsevier
Release : 2013-05-31
ISBN : 0857096427
Language : En, Es, Fr & De

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Book Description :

As medical devices become more intricate, with an increasing number of components made from a wide range of materials, it is important that they meet stringent requirements to ensure that they are safe to be implanted and will not be rejected by the human body. Joining and assembly of medical materials and devices provides a comprehensive overview of joining techniques for a range of medical materials and applications. Part one provides an introduction to medical devices and joining methods with further specific chapters on microwelding methods in medical components and the effects of sterilization on medical materials and welded devices. Part two focuses on medical metals and includes chapters on the joining of shape memory alloys, platinum (Pt) alloys and stainless steel wires for implantable medical devices and evaluating the corrosion performance of metal medical device welds. Part three moves on to highlight the joining and assembly of medical plastics and discusses techniques including ultrasonic welding, transmission laser welding and radio frequency (RF)/dielectric welding. Finally, part four discusses the joining and assembly of biomaterial and tissue implants including metal-ceramic joining techniques for orthopaedic applications and tissue adhesives and sealants for surgical applications. Joining and assembly of medical materials and devices is a technical guide for engineers and researchers within the medical industry, professionals requiring an understanding of joining and assembly techniques in a medical setting, and academics interested in this field. Introduces joining methods in medical applications including microwelding and considers the effects of sterilization on the resulting joints and devices Considers the joining, assembly and corrosion performance of medical metals including shape memory alloys, platinum alloys and stainless steel wires Considers the joining and assembly of medical plastics including multiple welding methods, bonding strategies and adhesives

Biocompatibility and Performance of Medical Devices

Biocompatibility and Performance of Medical Devices Book
Author : Jean-Pierre Boutrand
Publisher : Woodhead Publishing
Release : 2019-11-21
ISBN : 0081026447
Language : En, Es, Fr & De

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Book Description :

Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies. Presents diverse insights from experts in government, industry and academia Delivers a comprehensive overview of testing and interpreting medical device performance Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market

Medical Device Regulations

Medical Device Regulations Book
Author : Aakash Deep
Publisher : Academic Press
Release : 2022-01-13
ISBN : 0323911277
Language : En, Es, Fr & De

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Book Description :

Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers the registration procedures of medical devices for pharmaceutical regulatory organizations. Sections provide guidance on dealing with the ethical considerations of medical device development, compliance with patient confidentiality using information from medical devices, the interoperability between, and among devices outside of healthcare, and the dynamics of implementation of new devices to ensure patient safety. The author brings forth relevant issues, challenges and demonstrates how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom-line by demystifying the regulatory impact on operational requirements. Provides clear information on regulatory pathways for the design and commercialization of Medical Devices in different countries Explains the difference between standards and mandatory regulations for each region, along with discussions of regulations from USFDA (USA), CDSCO (India), EMEA (European Union), SFDA (China) and PMDA (Japan) Compiles regulations for medical devices and pharmaceuticals worldwide, helping readers create globally compliant products

Nanoparticles in Analytical and Medical Devices

Nanoparticles in Analytical and Medical Devices Book
Author : Fang Gang
Publisher : Elsevier
Release : 2020-09-01
ISBN : 0128225548
Language : En, Es, Fr & De

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Book Description :

Nanoparticles in Analytical and Medical Devices presents the latest information on the use of nanoparticles for a diverse range of analytical and medical applications. Covers basic principles, proper use of nanoparticles in analytical and medical applications, and recent progress in the field. This comprehensive reference helps readers grasp the full potential of nanoparticles in their analytical research or medical practice. Chapters on cutting-edge topics bring readers up to date on the latest research and usage of nanoparticles, and a chapter on commercially available devices that utilize nanoparticles guides readers in overcoming issues with marketing biodevices. Synthesizes nanoparticle conjugation and other critical methods Covers nanoparticles in analytical methods and real analytical devices currently used in the medical field Provides useful new information not covered in the current literature in chapters on surface chemical functionalization for bio-immobilization and nanoparticle production from natural sources

Wearable and Implantable Medical Devices

Wearable and Implantable Medical Devices Book
Author : Nilanjan Dey,Amira S. Ashour,Simon James Fong,Chintan Bhatt
Publisher : Academic Press
Release : 2019-09-06
ISBN : 0128156376
Language : En, Es, Fr & De

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Book Description :

Wearable and Implantable Medical Devices: Applications and Challenges, Fourth Edition highlights the new aspects of wearable and implanted sensors technology in the healthcare sector and monitoring systems. The book's contributions include several interdisciplinary domains, such as wearable sensors, implanted sensors devices, Internet-of-Things (IoT), security, real-time medical healthcare monitoring, WIBSN design and data management, encryption, and decision-support systems. Contributions emphasize several topics, including real-world applications and the design and implementation of wearable devices. This book demonstrates that this new field has a brilliant future in applied healthcare research and in healthcare monitoring systems. Includes comprehensive information on wearable and implanted device technology, wearable and implanted sensors design, WIBSN requirements, WIBSN in monitoring systems and security concepts Highlights machine learning and computing in healthcare monitoring systems based on WIBSN Includes a multidisciplinary approach to different healthcare applications and their associated challenges based on wearable and implanted technologies

Metals for Biomedical Devices

Metals for Biomedical Devices Book
Author : Mitsuo Niinomi
Publisher : Elsevier
Release : 2010-03-31
ISBN : 1845699246
Language : En, Es, Fr & De

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Book Description :

Despite recent advances in medical devices using other materials, metallic implants are still one of the most commercially significant sectors of the industry. Given the widespread use of metals in medical devices, it is vital that the fundamentals and behaviour of this material are understood. Metals in biomedical devices reviews the latest techniques in metal processing methods and the behaviour of this important material. Initial chapters review the current status and selection of metals for biomedical devices. Chapters in part two discuss the mechanical behaviour, degradation and testing of metals with specific chapters on corrosion, wear testing and biocompatibility of biomaterials. Part three covers the processing of metals for biomedical applications with chapters on such topics as forging metals and alloys, surface treatment, coatings and sterilisation. Chapters in the final section discuss clinical applications of metals such as cardiovascular, orthopaedic and new generation biomaterials. With its distinguished editor and team of expert contributors, Metals for biomedical devices is a standard reference for materials scientists, researchers and engineers working in the medical devices industry and academia. Reviews the latest techniques in metal processing methods including surface treatment and sterilisation Examines metal selection for biomedical devices considering biocompatibility of various metals Assesses mechanical behaviour and testing of metals featuring corrosion, fatigue and wear

Regulatory Affairs for Biomaterials and Medical Devices

Regulatory Affairs for Biomaterials and Medical Devices Book
Author : Stephen F. Amato,Robert M. Ezzell Jr
Publisher : Elsevier
Release : 2014-10-27
ISBN : 0857099205
Language : En, Es, Fr & De

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Book Description :

All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. Addresses global regulations and regulatory issues surrounding biomaterials and medical devices Especially useful for smaller companies who may not employ a full time vigilance professional Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing

Usability Testing of Medical Devices

Usability Testing of Medical Devices Book
Author : Michael E. Wiklund P.E.,Jonathan Kendler,Allison Y. Strochlic
Publisher : CRC Press
Release : 2015-12-23
ISBN : 1466595892
Language : En, Es, Fr & De

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Book Description :

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

Sterilization of Medical Devices

Sterilization of Medical Devices Book
Author : Anne Booth
Publisher : Routledge
Release : 2018-12-12
ISBN : 1351413813
Language : En, Es, Fr & De

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Book Description :

This book presents vital information on international sterilization standards and guidance on practical application of these standards in the manufacturing process. It covers validation, industrial sterilization methods, emerging sterilization techniques, laboratory testing, manufacturing of sterile devices, and device reuse. Excerpted from The Validator, edited by Anne F. Booth, more than fifty experts share their knowledge of current technologies in easy-to-understand articles that establish methods to ensure compliance. Contents include reviews of ISO sterilization standards, industrial sterilization methods and technologies, and support testing methodologies.

Innovation and Protection

Innovation and Protection Book
Author : I. Glenn Cohen,Timo Minssen,W. Nicholson Price II,Christopher Robertson,Carmel Shachar
Publisher : Cambridge University Press
Release : 2022-04-07
ISBN : 1108838634
Language : En, Es, Fr & De

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Book Description :

A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.

Biofilms and Implantable Medical Devices

Biofilms and Implantable Medical Devices Book
Author : Ying Deng,Wei Lv
Publisher : Woodhead Publishing
Release : 2016-10-24
ISBN : 0081003986
Language : En, Es, Fr & De

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Book Description :

Biofilms and Implantable Medical Devices: Infection and Control explores the increasing use of permanent and semi-permanent implants and indwelling medical devices. As an understanding of the growth and impact of biofilm formation on these medical devices and biomaterials is vital for protecting the health of the human host, this book provides readers with a comprehensive treatise on biofilms and their relationship with medical devices, also reporting on infections and associated strategies for prevention. Provides useful information on the fundamentals of biofilm problems in medical devices Discusses biofilm problems in a range of medical devices Focuses on strategies for prevention of biofilm formation