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Medical Devices

Medical Devices Book
Author : Bertil Jacobson,Alan Murray
Publisher : Elsevier Health Sciences
Release : 2007
ISBN : 0443102597
Language : En, Es, Fr & De

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Book Description :

Patient safety is important to all health professionals, but fatal accidents occur with medical devices every year. This is the first book for people who use medical equipment, rather than for engineers or technicians. It will help personnel within healthcare to avoid accidents by bridging the gap between the design principles and the user. The book encourages safe use of a wide range of equipment, from simple thermometers and blood-pressure cuffs to complex equipment such as pacemakers, ventilators and patient monitors. Simple explanations of basic medical devices Case histories of real-life accidents to highlight risk areas Clear, attractive illustrations "Tips" boxes identify particular problems "Basic Facts" boxes supply fundamental information needed by all readers "Technology" boxes provide more-advanced explanations for interested or experienced readers

Clinical Evaluation and Investigation of Medical Devices under the new EU Regulation

Clinical Evaluation and Investigation of Medical Devices under the new EU Regulation Book
Author : Wolfgang Ecker,Gerold Labek,Tarquin Mittermayr,Brigitte Raffeiner,Michael Ring,Bernhard Schwartz
Publisher : BoD – Books on Demand
Release : 2020-06-04
ISBN : 3751937668
Language : En, Es, Fr & De

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Book Description :

The concept of clinical evaluation and the framework for clinical investigations have been significantly enforced within the new EU-Medical Device Regulation (MDR). This book provides in-depth and practice-oriented guidance on the systematic identification and generation of clinical data through clinical investigations and other relevant sources. It addresses the needs of all stakeholders, be it manufacturers, notified bodies or competent authorities, when they have to plan, perform or assess clinical evaluations and investigations for medical devices on the way to conformity assessment and CE marking. It is a valuable tool of qualification for clinicians and related experts when preparing for a role of a clinical evaluator in the field, either when serving any of the stakeholders or when trying to make their own involvement stand out in start-ups. spin-offs or other development projects or in counselling services.

Electrically Active Materials for Medical Devices

Electrically Active Materials for Medical Devices Book
Author : Syed A M Tofail,Joanna Bauer
Publisher : World Scientific
Release : 2016-08-04
ISBN : 178326988X
Language : En, Es, Fr & De

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Book Description :

Stress induced electrical charges, action potential and electret behavior of bone, muscles, skin and nerve cells have been known for some time. Electrically Active Materials for Medical Devices builds on this knowledge and encourages readers to understand and exploit electrical activity in biomaterials from native, derived, or completely synthetic origin, or a combination thereof. It presents data and insights from both historic and contemporary research that spans over six decades with a view to generate convergence of interdisciplinary knowledge and skills. Divided into four parts, this book first introduces the reader to a general overview of electrically active materials in biology and biomedical science and describes important concepts and pioneering discoveries. The second part discusses common types of materials that are known to generate electrical activity and lays the foundation for these materials for use in medical devices. The third part gives examples of where electrically active materials have been examined for device application. The final part looks for upcoming and emerging concepts, tools and methodologies that are expected to shape the future profile of this field of converging science. Written by specialists in their respective fields, it has been specifically targeted at a readership of professionals, graduate students and researchers in the fields of biomedical engineering, physics, chemistry biology and clinical medicine.

New Medical Devices

New Medical Devices Book
Author : Institute of Medicine,National Academy of Engineering
Publisher : National Academies Press
Release : 1988-01-01
ISBN : 0309038472
Language : En, Es, Fr & De

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Book Description :

In the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the prevention and treatment of disease, but it also has contributed to the high cost of health care. Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the decision-making process behind private funding, the need for reforms in regulation and product liability, the effects of the medical payment system, and other critical topics relevant to the development of new devices.

Biocompatibility and Performance of Medical Devices

Biocompatibility and Performance of Medical Devices Book
Author : Jean-Pierre Boutrand
Publisher : Elsevier
Release : 2012-10-26
ISBN : 0857096451
Language : En, Es, Fr & De

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Book Description :

Implant and device manufacturers are increasingly facing the challenge of proving that their products are safe and biocompatible, and that they will perform as expected. Biocompatibility and performance of medical devices provides an essential guide to the performance analysis of these vital devices. Part one introduces the key concepts and challenges faced in relation to biocompatibility in medical devices, with consideration of biological safety evaluation planning and biomechanical and biochemical compatibility in innovative biomaterials. Part two goes on to discuss the evaluation and characterisation of biocompatibility in medical devices. Topics covered include material and chemical characterisation, allowable limits for toxic leachables, in vivo and in vitro testing and blood compatibility assessment. Testing and interpreting medical device performance is the focus of part three, with chapters describing preclinical performance studies for bone, dental and soft tissue implants, and mechanical testing of soft and hard tissue implants. Part four provides information on the regulation of medical devices in the European Union, Japan and China, and the book concludes with part five, a review of histopathology principles for biocompatibility and performance studies. With its distinguished editor and international team of expert contributors, Biocompatibility and performance of medical devices is a vital tool for all those involved in the research, design, production and application of medical devices, including research directors, production companies and medical regulatory agencies, as well as industry professionals and academics. Examines the key concepts and challenges faced in relation to biocompatibility in medical devices Discusses evaluation and characterisation issues, including material and chemical characterization, allowable limits for toxic leachables, in vivo and in vitro testing, and blood compatibility assessment Delivers a comprehensive overview of testing and interpreting medical device performance

Handbook of Polymer Applications in Medicine and Medical Devices

Handbook of Polymer Applications in Medicine and Medical Devices Book
Author : Kayvon Modjarrad,Sina Ebnesajjad
Publisher : Elsevier
Release : 2013-12-05
ISBN : 0323221696
Language : En, Es, Fr & De

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Book Description :

While the prevalence of plastics and elastomers in medical devices is now quite well known, there is less information available covering the use of medical devices and the applications of polymers beyond medical devices, such as in hydrogels, biopolymers and silicones beyond enhancement applications, and few books in which these are combined into a single reference. This book is a comprehensive reference source, bringing together a number of key medical polymer topics in one place for a broad audience of engineers and scientists, especially those currently developing new medical devices or seeking more information about current and future applications. In addition to a broad range of applications, the book also covers clinical outcomes and complications arising from the use of the polymers in the body, giving engineers a vital insight into the real world implications of the devices they’re creating. Regulatory issues are also covered in detail. The book also presents the latest developments on the use of polymers in medicine and development of nano-scale devices. Gathers discussions of a large number of applications of polymers in medicine in one place Provides an insight into both the legal and clinical implications of device design Relevant to industry, academic and medical professionals Presents the latest developments in the field, including medical devices on a nano-scale

Guide to Microbiological Control in Pharmaceuticals and Medical Devices Second Edition

Guide to Microbiological Control in Pharmaceuticals and Medical Devices  Second Edition Book
Author : Stephen P. Denyer,Rosamund M. Baird
Publisher : CRC Press
Release : 2006-12-26
ISBN : 1420021621
Language : En, Es, Fr & De

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Book Description :

Microbiological matters continue to exercise considerable influence on product quality. In both the pharmaceutical and medical device industries, products of greater sophistication, along with evolving regulatory requirements, are elevating the challenges related to maintaining microbiological integrity. Updated to reflect technological and regulatory changes, the Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition covers thoseprincipal aspects of microbiology that arerelevant to the preformulation, formulation, manufacturing, and license application stages involved with the production of pharmaceuticals and medical devices. In recognition of the diverse disciplines involved in pharmaceutical and medical device production, this work provides a brief introduction to microbiology geared towards the nonmicrobiologist. Covering good manufacturing practice in the control of contamination, the text explores quality control, the preservation of formulations, and principles of sterilization, including microbiological-specific considerations for biotechnological products and other medical devices. It also provides additional materials on package integrity and contamination risks in clean rooms. The editors have produced a companion text, the Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices (see reverse), which when paired with the Guide offers a complete theoretical and practical treatment of microbiological control. This book provides a comprehensive distillation of information concerning methodology and regulations that would otherwise remain scattered throughout the literature. It allows scientists from many fields to address potential problems in advance and implement suitable strategies at the earliest stages of development.

Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices Book
Author : Bijan Elahi
Publisher : Academic Press
Release : 2018-06-29
ISBN : 0128130997
Language : En, Es, Fr & De

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Book Description :

Safety Risk Management for Medical Devices demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work. Written with practicing engineers, safety management professionals, and students in mind, this book will help readers tackle the difficult questions, such as how to define risk acceptance criteria and how to determine when to stop risk reduction. This book delivers not only theory, but also practical guidance for applying the theory in daily risk management work. The reader is familiarized with the vocabulary of risk management and guided through a process to ensure compliance with the international standard ISO 14971—a requirement for all medical devices. This book outlines sensible, easily comprehensible, and state-of the-art methodologies that are rooted in current industry best practices. Opening chapters introduce the concept of risk, the legal basis for risk management, and the requirements for a compliant risk-management process. The next group of chapters discusses the connection between risk management and quality systems, usability engineering and biocompatibility. This book delves into the techniques of risk management, such as fault tree analysis and failure modes and effects analysis, and continues with risk estimation, risk control, and risk evaluation. Special topics such as software risk management, clinical investigations, and security are also discussed. The latter chapters address benefit-risk analysis, and production and postproduction monitoring. This book concludes with advice and wisdom for sensible, efficient, and successful safety risk management of medical devices. Teaches industry best practices on medical-device risk management in compliance with ISO 14971 Provides practical, easy-to-understand, and step-by-step instructions on how to perform hazard analysis and manage the risks of medical devices Offers a worked-out example applying the risk management process on a hypothetical device

Security and Privacy for Implantable Medical Devices

Security and Privacy for Implantable Medical Devices Book
Author : Wayne Burleson,Sandro Carrara
Publisher : Springer Science & Business Media
Release : 2013-12-03
ISBN : 1461416744
Language : En, Es, Fr & De

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Book Description :

This book presents a systematic approach to analyzing the challenging engineering problems posed by the need for security and privacy in implantable medical devices (IMD). It describes in detail new issues termed as lightweight security, due to the associated constraints on metrics such as available power, energy, computing ability, area, execution time, and memory requirements. Coverage includes vulnerabilities and defense across multiple levels, with basic abstractions of cryptographic services and primitives such as public key cryptography, block ciphers and digital signatures. Experts from Computer Security and Cryptography present new research which shows vulnerabilities in existing IMDs and proposes solutions. Experts from Privacy Technology and Policy will discuss the societal, legal and ethical challenges surrounding IMD security as well as technological solutions that build on the latest in Computer Science privacy research, as well as lightweight solutions appropriate for implementation in IMDs.

Polymers in Disposable Medical Devices

Polymers in Disposable Medical Devices Book
Author : Colin R. Blass
Publisher : iSmithers Rapra Publishing
Release : 1999
ISBN : 9781859571828
Language : En, Es, Fr & De

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Book Description :

Download Polymers in Disposable Medical Devices book written by Colin R. Blass, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Sterilisation of Biomaterials and Medical Devices

Sterilisation of Biomaterials and Medical Devices Book
Author : Sophie Lerouge,Anne Simmons
Publisher : Elsevier
Release : 2012-09-27
ISBN : 0857096265
Language : En, Es, Fr & De

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Book Description :

The effective sterilisation of any material or device to be implanted in or used in close contact with the human body is essential for the elimination of harmful agents such as bacteria. Sterilisation of biomaterials and medical devices reviews established and commonly used technologies alongside new and emerging processes. Following an introduction to the key concepts and challenges involved in sterilisation, the sterilisation of biomaterials and medical devices using steam and dry heat, ionising radiation and ethylene oxide is reviewed. A range of non-traditional sterilisation techniques, such as hydrogen peroxide gas plasma, ozone and steam formaldehyde, is then discussed together with research in sterilisation and decontamination of surfaces by plasma discharges. Sterilisation techniques for polymers, drug-device products and tissue allografts are then reviewed, together with antimicrobial coatings for ‘self-sterilisation’ and the challenge presented by prions and endotoxins in the sterilisation of reusable medical devices. The book concludes with a discussion of future trends in the sterilisation of biomaterials and medical devices. With its distinguished editors and expert team of international contributors, Sterilisation of biomaterials and medical devices is an essential reference for all materials scientists, engineers and researchers within the medical devices industry. It also provides a thorough overview for academics and clinicians working in this area. Reviews established and commonly used technologies alongside new and emerging processes Introduces and reviews the key concepts and challenges involved in sterilisation Discusses future trends in the sterilisation of biomaterials and medical devices

Materials and Coatings for Medical Devices

Materials and Coatings for Medical Devices Book
Author : Anonim
Publisher : ASM International
Release : 2009-01-01
ISBN : 1615031359
Language : En, Es, Fr & De

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Book Description :

"The Materials Information Society, MPMD-Materials and Processes for Medical Devices."

Advances in Human Factors and Ergonomics in Healthcare and Medical Devices

Advances in Human Factors and Ergonomics in Healthcare and Medical Devices Book
Author : Jay Kalra,Nancy J. Lightner,Redha Taiar
Publisher : Springer
Release : 2021-07-08
ISBN : 9783030807436
Language : En, Es, Fr & De

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Book Description :

This book is concerned with human factors and ergonomics research and developments in the design and use of systems and devices for effective and safe healthcare delivery. It reports on approaches for improving healthcare devices so that they better fit to people’s, including special population’s needs. It also covers assistive devices aimed at reducing occupational risks of health professionals as well as innovative strategies for error reduction, and more effective training and education methods for healthcare workers and professionals. Equal emphasis is given to digital technologies and to physical, cognitive and organizational aspects, which are considered in an integrated manner, so as to facilitate a systemic approach for improving the quality and safety of healthcare service. The book also includes a special section dedicated to innovative strategies for assisting caregivers’, patients’, and people’s needs during pandemic. Based on papers presented at the AHFE 2021 Conference on Human Factors and Ergonomics in Healthcare and Medical Devices, held virtually on 25–29 July, 2021, from USA, the book offers a timely reference guide to both researchers and healthcare professionals involved in the design of medical systems and managing healthcare settings, as well as to healthcare counselors and global health organizations.

Medical Devices

Medical Devices Book
Author : World Health Organization
Publisher : World Health Organization
Release : 2010
ISBN : 9241564040
Language : En, Es, Fr & De

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Book Description :

Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9

Plastics in Medical Devices for Cardiovascular Applications

Plastics in Medical Devices for Cardiovascular Applications Book
Author : Ajay Padsalgikar
Publisher : William Andrew
Release : 2017-02-01
ISBN : 0323371221
Language : En, Es, Fr & De

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Book Description :

Plastics in Medical Devices for Cardiovascular Applications enables designers of new cardiovascular medical devices to make decisions about the kind of plastics that can go into the manufacture of their device by explaining the property requirements of various applications in this area, including artificial valves, lead insulation, balloons, vascular grafts, and more. Enables designers to improve device performance and remain compliant with regulations by selecting the best material for each application Presents a range of applications, including artificial valves, stents, and vascular grafts Explains which materials can be used for each application, and why each is appropriate, thus assisting in the design of better tools and processes

Flexible and Stretchable Medical Devices

Flexible and Stretchable Medical Devices Book
Author : Kuniharu Takei
Publisher : John Wiley & Sons
Release : 2018-04-23
ISBN : 3527341838
Language : En, Es, Fr & De

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Book Description :

The book introduces flexible and stretchable wearable electronic systems and covers in detail the technologies and materials required for healthcare and medical applications. A team of excellent authors gives an overview of currently available flexible devices and thoroughly describes their physical mechanisms that enable sensing human conditions. In dedicated chapters, crucial components needed to realize flexible and wearable devices are discussed which include transistors and sensors and deal with memory, data handling and display. Additionally, suitable power sources based on photovoltaics, thermoelectric energy and supercapacitors are reviewed. A special chapter treats implantable flexible sensors for neural recording. The book editor concludes with a perspective on this rapidly developing field which is expected to have a great impact on healthcare in the 21st century.

Trends in Development of Medical Devices

Trends in Development of Medical Devices Book
Author : Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam
Publisher : Academic Press
Release : 2020-01-25
ISBN : 0128209615
Language : En, Es, Fr & De

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Book Description :

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

Inventing Medical Devices

Inventing Medical Devices Book
Author : Anonim
Publisher : Unknown
Release : 2016
ISBN : 9789352068692
Language : En, Es, Fr & De

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Book Description :

Download Inventing Medical Devices book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Data Integrity in Pharmaceutical and Medical Devices Regulation Operations

Data Integrity in Pharmaceutical and Medical Devices Regulation Operations Book
Author : Orlando Lopez
Publisher : CRC Press
Release : 2016-11-03
ISBN : 1315349973
Language : En, Es, Fr & De

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Book Description :

Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years’ experience in regulated industries in various computer systems development, maintenance, and quality functions. In addition to case studies, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.

DESIGN CONTROLS RISK MANAGEMENT PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS

DESIGN CONTROLS  RISK MANAGEMENT   PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS Book
Author : Vernon Geckler
Publisher : Wasatch Consulting Resources LLC
Release : 2017-02-11
ISBN : 0692835415
Language : En, Es, Fr & De

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Book Description :

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.