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Medical Devices

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Medical Devices

Medical Devices Book
Author : Michael Bilirakis
Publisher : DIANE Publishing
Release : 1997-06-01
ISBN : 9780788180996
Language : En, Es, Fr & De

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Book Description :

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 .

Medical Devices

Medical Devices Book
Author : United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Public Health and Environment
Publisher : Unknown
Release : 1974
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Medical Devices book written by United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Public Health and Environment, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Medical Devices

Medical Devices Book
Author : United States. Congress. Senate. Committee on Labor and Human Resources
Publisher : Unknown
Release : 1991
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Medical Devices book written by United States. Congress. Senate. Committee on Labor and Human Resources, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Medical Devices

Medical Devices Book
Author : United States. General Accounting Office
Publisher : Unknown
Release : 1995
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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

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

Federal policies and the medical devices industry

Federal policies and the medical devices industry  Book
Author : Anonim
Publisher : DIANE Publishing
Release : 2021-05-12
ISBN : 1428923691
Language : En, Es, Fr & De

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Book Description :

Download Federal policies and the medical devices industry book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Medical Devices

Medical Devices Book
Author : Martin Culjat,Rahul Singh,Hua Lee
Publisher : John Wiley & Sons
Release : 2012-11-07
ISBN : 1118453530
Language : En, Es, Fr & De

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Book Description :

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 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

Medical Device Materials V

Medical Device Materials V Book
Author : Jeremy Gilbert
Publisher : ASM International
Release : 2010
ISBN : 1615031413
Language : En, Es, Fr & De

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Book Description :

Download Medical Device Materials V book written by Jeremy Gilbert, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Good Manufacturing Practices for Medical Devices

Good Manufacturing Practices for Medical Devices Book
Author : United States. Bureau of Medical Devices
Publisher : Unknown
Release : 1979
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Good Manufacturing Practices for Medical Devices book written by United States. Bureau of Medical Devices, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

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

Standards Survey

Standards Survey Book
Author : United States. Bureau of Medical Devices
Publisher : Unknown
Release : 1981
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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The Development of Medical Devices

The Development of Medical Devices Book
Author : Dirk Lanzerath,Sebastian von Kielmansegg,Joerg Hasford
Publisher : LIT Verlag Münster
Release : 2020-04
ISBN : 3643912609
Language : En, Es, Fr & De

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Book Description :

Medical devices include objects, substances and software that are used for therapeutic or diagnostic purposes for humans. However, the main intended effect, in contrast to medicinal products, is not primarily pharmacological, metabolic or immunological, but usually physical or physicochemical. The innovation cycles for many modern implantable medical devices are estimated to be about 18 months, for software even shorter. It is obvious that the evaluation of the performance, the effectiveness, the benefits and risks of a medical devices is very different compared to medicinal products. The recent EU-Regulation on medical devices asks for very requirements regarding the systematic evaluation of medical devices in humans and the procedures for granting the CE mark. The recent volume of the series MEDICAL ETHICS addresses the ethical, legal, methodological, and practical challenges arising from the Regulation regarding the development and use of medical devices.

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 : 2010-12-20
ISBN : 9781439811849
Language : En, Es, Fr & De

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Book Description :

To paraphrase a popular saying, usability testing should be done early and often. However, it doesn't have to be an onerous process. Informative, practical, and engaging, Usability Testing of Medical Devices provides a simple, easy to implement general understanding of usability testing. It offers a general understanding of usability testing and re

Bureau of Medical Devices Standards Survey

Bureau of Medical Devices Standards Survey Book
Author : United States. Bureau of Medical Devices
Publisher : Unknown
Release : 1979
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Bureau of Medical Devices Standards Survey book written by United States. Bureau of Medical Devices, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

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.

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 : 9781420021622
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.

Clinical Evaluation of Medical Devices

Clinical Evaluation of Medical Devices Book
Author : Karen Becker Witkin
Publisher : Springer Science & Business Media
Release : 2013-03-09
ISBN : 1475727569
Language : En, Es, Fr & De

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Book Description :

The world is changing rapidly, and nowhere is this more apparent than in medicine. The standards are rapidly rising in the field of medical device trials. A few years ago, device developers would look askance if one told them that medical device trials and drug trials should have the same stan dards. Today, such a statement does not seem as outrageous, although there is still a large gap in the design of trials and number oftrials conducted for medical device and drug development programs. More than 20 years after the enactment of the US Medical Device Amendments, we can see that they served as an impetus to raise clinical trial standards for devices. Whether the data to establish the safety and efficacy of a device come from one, two, or even more clinical trials is less important in evaluating the device than whether the data are medically and scientifically support ive of its safety and efficacy. Having at least two separate studies, and at least two sites confirm results, adds a great deal of scientific credibility and support to a conclusion of safety and efficacy, even though a confirmatory trial is not yet a regulatory requirement in most countries.

Workbook of Medical Devices Engineering and Technology

Workbook of Medical Devices  Engineering and Technology Book
Author : Michael Thoms
Publisher : tredition
Release : 2020-06-17
ISBN : 3347075137
Language : En, Es, Fr & De

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Book Description :

This workbook provides exercises and corresponding solutions to several subjects in medical technology and engineering. Thereby the reader can learn how to solve problems in this field by means of mathematical formulas and calculations. In order to provide a better understanding, the physical background for the solutions is shortly explained. The workbook covers excercises on the following topics: -Interaction of X-rays with matter -X-ray tubes -X-ray dosimetry -X-ray statistics -Ultrasound waves -Ultrasound scanner -Dipole fields in electrocardiography -Electrocardiography instrumentation -Interaction of laser light with matter -Application of laser radiation -Pulse oxymetry -High-frequency surgery -Computed radiography (CR) -Image reconstruction in computed tomography -CT scanner -Nuclear magnetic resonance and nuclear magnetic resonance imaging -Nuclear medical imaging, radionuclides and instrumentation -Binary classification and Receiver operator characteristic curves -Modulation transfer function in imaging -Detective quantum efficiency

Integrated Safety and Risk Assessment for Medical Devices and Combination Products

Integrated Safety and Risk Assessment for Medical Devices and Combination Products Book
Author : Shayne C. Gad
Publisher : Springer Nature
Release : 2020-02-24
ISBN : 3030352412
Language : En, Es, Fr & De

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Book Description :

While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation. Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex. A part of this, requirements for ensuring safety (once based on use of previously acceptable materials – largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant (yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understand, and solve all of them. • Identify and verify the most appropriate available data. • As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest. • As the duration (and rate) of exposure to moieties released from a device are most frequently different (longer) than what available data speaks to, transformation across tissue is required. • As innate and adaptive immune responses are a central part of device/patient interaction, assessing potential risks on this basis are required. • Incorporating assessments for special populations such as neonates. • Use of (Q)SAR (Quantitative Structure Activity Relationships) modeling in assessments. • Performance and presentation of integrative assessments covering all potential biologic risks. Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devices.