Medical Devices: Measurements, Quality Assurance, and Standards
Author: Cesar Augusto Caceres
Publisher: ASTM International
Published: 1983
Total Pages: 319
ISBN-13:
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Medical Device Quality Assurance and Regulatory Compliance
Author: Richard C. Fries
Publisher: CRC Press
Published: 1998-08-11
Total Pages: 497
ISBN-13: 148227003X
DOWNLOAD EBOOK"Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."
Medical Devices and Human Engineering
Author: Joseph D. Bronzino
Publisher: CRC Press
Published: 2014-12-17
Total Pages: 896
ISBN-13: 1439825254
DOWNLOAD EBOOKKnown as the bible of biomedical engineering, The Biomedical Engineering Handbook, Fourth Edition, sets the standard against which all other references of this nature are measured. As such, it has served as a major resource for both skilled professionals and novices to biomedical engineering. Medical Devices and Human Engineering, the second volume of the handbook, presents material from respected scientists with diverse backgrounds in biomedical sensors, medical instrumentation and devices, human performance engineering, rehabilitation engineering, and clinical engineering. More than three dozen specific topics are examined, including optical sensors, implantable cardiac pacemakers, electrosurgical devices, blood glucose monitoring, human–computer interaction design, orthopedic prosthetics, clinical engineering program indicators, and virtual instruments in health care. The material is presented in a systematic manner and has been updated to reflect the latest applications and research findings.
The Medical Device Industry
Author: Norman F. Estrin
Publisher: CRC Press
Published: 1990-08-31
Total Pages: 1020
ISBN-13: 9780824782689
DOWNLOAD EBOOKPractical information about the complexities of biomedical technology and regulation, and their implications for manufacturers and marketers of health care devices. Written primarily for those in the industry concerned about staying competitive in light of complex and fluctuating regulatory approach
Medical Device Regulations
Author: Aakash Deep
Publisher: Academic Press
Published: 2022-01-13
Total Pages: 187
ISBN-13: 0323911277
DOWNLOAD EBOOKMedical 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
The Biomedical Engineering Handbook
Author: Joseph D. Bronzino
Publisher: CRC Press
Published: 2018-10-03
Total Pages: 5245
ISBN-13: 1439863113
DOWNLOAD EBOOKThe definitive bible for the field of biomedical engineering, this collection of volumes is a major reference for all practicing biomedical engineers and students. Now in its fourth edition, this work presents a substantial revision, with all sections updated to offer the latest research findings. New sections address drugs and devices, personalized medicine, and stem cell engineering. Also included is a historical overview as well as a special section on medical ethics. This set provides complete coverage of biomedical engineering fundamentals, medical devices and systems, computer applications in medicine, and molecular engineering.
Biomedical Engineering Handbook 2
Author: Joseph D. Bronzino
Publisher: Springer Science & Business Media
Published: 2000-02-15
Total Pages: 1528
ISBN-13: 9783540668084
DOWNLOAD EBOOKBioelectronics and Medical Devices
Author: Kunal Pal
Publisher: Woodhead Publishing
Published: 2019-06-15
Total Pages: 1006
ISBN-13: 0081024215
DOWNLOAD EBOOKBioelectronics and Medical Devices: From Materials to Devices-Fabrication, Applications and Reliability reviews the latest research on electronic devices used in the healthcare sector, from materials, to applications, including biosensors, rehabilitation devices, drug delivery devices, and devices based on wireless technology. This information is presented from the unique interdisciplinary perspective of the editors and contributors, all with materials science, biomedical engineering, physics, and chemistry backgrounds. Each applicable chapter includes a discussion of these devices, from materials and fabrication, to reliability and technology applications. Case studies, future research directions and recommendations for additional readings are also included. The book addresses hot topics, such as the latest, state-of the-art biosensing devices that have the ability for early detection of life-threatening diseases, such as tuberculosis, HIV and cancer. It covers rehabilitation devices and advancements, such as the devices that could be utilized by advanced-stage ALS patients to improve their interactions with the environment. In addition, electronic controlled delivery systems are reviewed, including those that are based on artificial intelligences. - Presents the latest topics, including MEMS-based fabrication of biomedical sensors, Internet of Things, certification of medical and drug delivery devices, and electrical safety considerations - Presents the interdisciplinary perspective of materials scientists, biomedical engineers, physicists and chemists on biomedical electronic devices - Features systematic coverage in each chapter, including recent advancements in the field, case studies, future research directions, and recommendations for additional readings
Measuring the Quality of Health Care
Author: The National Roundtable on Health Care Quality
Publisher: National Academies Press
Published: 1999-02-23
Total Pages: 42
ISBN-13: 0309570689
DOWNLOAD EBOOKThe National Roundtable on Health Care Quality was established in 1995 by the Institute of Medicine. The Roundtable consists of experts formally appointed through procedures of the National Research Council (NRC) who represent both public and private-sector perspectives and appropriate areas of substantive expertise (not organizations). From the public sector, heads of appropriate Federal agencies serve. It offers a unique, nonadversarial environment to explore ongoing rapid changes in the medical marketplace and the implications of these changes for the quality of health and health care in this nation. The Roundtable has a liaison panel focused on quality of care in managed care organizations. The Roundtable convenes nationally prominent representatives of the private and public sector (regional, state and federal), academia, patients, and the health media to analyze unfolding issues concerning quality, to hold workshops and commission papers on significant topics, and when appropriate, to produce periodic statements for the nation on quality of care matters. By providing a structured opportunity for regular communication and interaction, the Roundtable fosters candid discussion among individuals who represent various sides of a given issue.
Clinical Engineering
Author: Yadin David
Publisher: CRC Press
Published: 2003-03-26
Total Pages: 426
ISBN-13: 0203009177
DOWNLOAD EBOOKA volume in the Principles and Applications in Engineering series, Clinical Engineering focuses on managing the deployment of medical technology and integrating it appropriately with desired clinical practices. It provides a description of the wide range of responsibilities clinical engineers encounter, describes technology management and assessmen
