Medical Devices

Medical Devices
Author: Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
Publsiher: Woodhead Publishing
Total Pages: 256
Release: 2015-08-18
ISBN 10: 0081002912
ISBN 13: 9780081002919
Language: EN, FR, DE, ES & NL

Medical Devices Book Review:

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

Nanoparticles in Analytical and Medical Devices

Nanoparticles in Analytical and Medical Devices
Author: Fang Gang
Publsiher: Elsevier
Total Pages: 344
Release: 2020-09-11
ISBN 10: 0128225548
ISBN 13: 9780128225547
Language: EN, FR, DE, ES & NL

Nanoparticles in Analytical and Medical Devices Book Review:

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

Medical Devices

Medical Devices
Author: Michael Bilirakis
Publsiher: DIANE Publishing
Total Pages: 86
Release: 1997-06-01
ISBN 10: 9780788180996
ISBN 13: 0788180991
Language: EN, FR, DE, ES & NL

Medical Devices Book Review:

Hearing on technological advances in the field of medical devices from the perspective of the Food & Drug Admin. (FDA), as well as from patients & providers. Witnesses: Michael Friedman, Bruce Burlington, & Susan Alpert, FDA; John F. Hansbrough, Dir. of the Regional Burn Center, UCSD Medical Center; C. Warren Olanow, Chairman, Dept. of Neurology, Mount Sinai Medical Center; Robert A. Schmidt, Dir. of Mammography, Univ. of Chicago Hospitals; Joseph M. Smith, Asst. Prof. of Medicine, Washington University School of Medicine; & Joy Vaas. Also includes prepared statement submitted by Nonprescription Drug Manufacturers Assoc .

Sterilization of Medical Devices

Sterilization of Medical Devices
Author: Anne Booth
Publsiher: Routledge
Total Pages: 424
Release: 2018-12-12
ISBN 10: 1351413813
ISBN 13: 9781351413817
Language: EN, FR, DE, ES & NL

Sterilization of Medical Devices Book Review:

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.

Biocompatibility and Performance of Medical Devices

Biocompatibility and Performance of Medical Devices
Author: Jean-Pierre Boutrand
Publsiher: Woodhead Publishing
Total Pages: 586
Release: 2019-11-21
ISBN 10: 0081026447
ISBN 13: 9780081026441
Language: EN, FR, DE, ES & NL

Biocompatibility and Performance of Medical Devices Book Review:

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

Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices
Author: Bijan Elahi
Publsiher: Academic Press
Total Pages: 424
Release: 2018-06-29
ISBN 10: 0128130997
ISBN 13: 9780128130995
Language: EN, FR, DE, ES & NL

Safety Risk Management for Medical Devices Book Review:

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

Medical Instruments and Devices

Medical Instruments and Devices
Author: Steven Schreiner,Joseph D. Bronzino,Donald R. Peterson
Publsiher: CRC Press
Total Pages: 320
Release: 2015-07-24
ISBN 10: 1439871477
ISBN 13: 9781439871478
Language: EN, FR, DE, ES & NL

Medical Instruments and Devices Book Review:

Medical Instruments and Devices: Principles and Practices originates from the medical instruments and devices section of The Biomedical Engineering Handbook, Fourth Edition. Top experts in the field provide material that spans this wide field. The text examines how biopotential amplifiers help regulate the quality and content of measured signals. I

Emerging Nanotechnologies for Diagnostics Drug Delivery and Medical Devices

Emerging Nanotechnologies for Diagnostics  Drug Delivery and Medical Devices
Author: Ashim K Mitra,Kishore Cholkar,Abhirup Mandal
Publsiher: William Andrew
Total Pages: 416
Release: 2017-02-13
ISBN 10: 0323429971
ISBN 13: 9780323429979
Language: EN, FR, DE, ES & NL

Emerging Nanotechnologies for Diagnostics Drug Delivery and Medical Devices Book Review:

Emerging Nanotechnologies for Diagnostics, Drug Delivery and Medical Devices covers the modern micro and nanotechnologies used for diagnosis, drug delivery, and theranostics using micro, nano, and implantable systems. In-depth coverage of all aspects of disease treatment is included. In addition, the book covers cutting-edge research and technology that will help readers gain knowledge of novel approaches and their applications to improve drug/agent specificity for diagnosis and efficient disease treatment. It is a comprehensive guide for medical specialists, the pharmaceutical-industry, and academic researchers discussing the impact of nanotechnology on diagnosis, drug delivery, and theranostics. Gives readers working in immunology, drug delivery, and medicine a greater awareness on how novel nanotechnology orientated methods can help improve treatment Provides readers with backgrounds in nanotechnology, chemistry, and materials science an understanding on how nanotechnology is used in immunology and drug delivery Includes focused coverage of the use of nanodevices in diagnostics, therapeutics, and theranostics not offered by other books

Trends in Development of Medical Devices

Trends in Development of Medical Devices
Author: Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam
Publsiher: Academic Press
Total Pages: 216
Release: 2020-01-25
ISBN 10: 0128209615
ISBN 13: 9780128209615
Language: EN, FR, DE, ES & NL

Trends in Development of Medical Devices Book Review:

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 Safety

Medical Device Safety
Author: G.R Higson
Publsiher: CRC Press
Total Pages: 286
Release: 2001-10-29
ISBN 10: 1420033980
ISBN 13: 9781420033984
Language: EN, FR, DE, ES & NL

Medical Device Safety Book Review:

Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, engineering, and medical regulatory affairs.

Federal policies and the medical devices industry

Federal policies and the medical devices industry
Author: Anonim
Publsiher: DIANE Publishing
Total Pages: 329
Release: 2021
ISBN 10: 1428923691
ISBN 13: 9781428923690
Language: EN, FR, DE, ES & NL

Federal policies and the medical devices industry Book Review:

Reliable Design of Medical Devices

Reliable Design of Medical Devices
Author: Richard C. Fries
Publsiher: CRC Press
Total Pages: 504
Release: 2005-11-21
ISBN 10: 1420027948
ISBN 13: 9781420027945
Language: EN, FR, DE, ES & NL

Reliable Design of Medical Devices Book Review:

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.

Usability Testing of Medical Devices

Usability Testing of Medical Devices
Author: Michael E. Wiklund P.E.,Jonathan Kendler,Allison Y. Strochlic
Publsiher: CRC Press
Total Pages: 477
Release: 2015-12-23
ISBN 10: 1466595892
ISBN 13: 9781466595897
Language: EN, FR, DE, ES & NL

Usability Testing of Medical Devices Book Review:

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

Medical Devices

Medical Devices
Author: Martin Culjat,Rahul Singh,Hua Lee
Publsiher: John Wiley & Sons
Total Pages: 456
Release: 2012-11-07
ISBN 10: 1118453530
ISBN 13: 9781118453537
Language: EN, FR, DE, ES & NL

Medical Devices Book Review:

Addressing the exploding interest in bioengineering for healthcare applications, this book provides readers with detailed yet easy-to-understand guidance on biomedical device engineering. Written by prominent physicians and engineers, Medical Devices: Surgical and Image-Guided Technologies is organized into stand-alone chapters covering devices and systems in diagnostic, surgical, and implant procedures. Assuming only basic background in math and science, the authors clearly explain the fundamentals for different systems along with such topics as engineering considerations, therapeutic techniques and applications, future trends, and more. After describing how to manage a design project for medical devices, the book examines the following: Instruments for laparoscopic and ophthalmic surgery, plus surgical robotics Catheters in vascular therapy and energy-based hemostatic surgical devices Tissue ablation systems and the varied uses of lasers in medicine Vascular and cardiovascular devices, plus circulatory support devices Ultrasound transducers, X-ray imaging, and neuronavigation An absolute must for biomedical engineers, Medical Devices: Surgical and Image-Guided Technologies is also an invaluable guide for students in all engineering majors and pre-med programs interested in exploring this fascinating field.

Medical Devices

Medical Devices
Author: Bertil Jacobson,Alan Murray
Publsiher: Elsevier Health Sciences
Total Pages: 376
Release: 2007
ISBN 10: 0443102597
ISBN 13: 9780443102592
Language: EN, FR, DE, ES & NL

Medical Devices Book Review:

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

Medical Device Materials V

Medical Device Materials V
Author: Jeremy Gilbert
Publsiher: ASM International
Total Pages: 273
Release: 2010
ISBN 10: 1615031413
ISBN 13: 9781615031412
Language: EN, FR, DE, ES & NL

Medical Device Materials V Book Review:

Medical Devices Application of Risk Management to Medical Devices

Medical Devices   Application of Risk Management to Medical Devices
Author: Anonim
Publsiher: Unknown
Total Pages: 82
Release: 2007
ISBN 10:
ISBN 13: OCLC:652660089
Language: EN, FR, DE, ES & NL

Medical Devices Application of Risk Management to Medical Devices Book Review:

Plastics in Medical Devices

Plastics in Medical Devices
Author: Vinny R. Sastri
Publsiher: Elsevier
Total Pages: 352
Release: 2010-03-05
ISBN 10: 081552028X
ISBN 13: 9780815520283
Language: EN, FR, DE, ES & NL

Plastics in Medical Devices Book Review:

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.

Biofilms and Implantable Medical Devices

Biofilms and Implantable Medical Devices
Author: Ying Deng,Wei Lv
Publsiher: Woodhead Publishing
Total Pages: 238
Release: 2016-10-24
ISBN 10: 0081003986
ISBN 13: 9780081003985
Language: EN, FR, DE, ES & NL

Biofilms and Implantable Medical Devices Book Review:

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

Medical Devices

Medical Devices
Author: World Health Organization
Publsiher: World Health Organization
Total Pages: 129
Release: 2010
ISBN 10: 9241564040
ISBN 13: 9789241564045
Language: EN, FR, DE, ES & NL

Medical Devices Book Review:

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