Medical Devices: Measurements, Quality Assurance, and Standards
| Author | : Cesar Augusto Caceres |
| Publisher | : ASTM International |
| Total Pages | : 319 |
| Release | : 1983 |
| Genre | : Medical instruments and apparatus |
| ISBN | : |
Medical Devices Measurements Quality Assurance And Standards
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Measuring the Quality of Health Care
| Author | : The National Roundtable on Health Care Quality |
| Publisher | : National Academies Press |
| Total Pages | : 42 |
| Release | : 1999-02-23 |
| Genre | : Medical |
| ISBN | : 0309570689 |
The 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.
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
| Author | : Amiram Daniel |
| Publisher | : Quality Press |
| Total Pages | : 338 |
| Release | : 2008-01-01 |
| Genre | : Medical |
| ISBN | : 0873897404 |
How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes an update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs.
Dacie and Lewis Practical Haematology E-Book
| Author | : Barbara J. Bain |
| Publisher | : Elsevier Health Sciences |
| Total Pages | : 599 |
| Release | : 2016-08-11 |
| Genre | : Medical |
| ISBN | : 0702069256 |
For more than 65 years, this best-selling text by Drs. Barbara J. Bain, Imelda Bates, and Mike A. Laffan has been the worldwide standard in laboratory haematology. The 12th Edition of Dacie and Lewis Practical Haematology continues the tradition of excellence with thorough coverage of all of the techniques used in the investigation of patients with blood disorders, including the latest technologies as well as traditional manual methods of measurement. You'll find expert discussions of the principles of each test, possible causes of error, and the interpretation and clinical significance of the findings. - A unique section on haematology in under-resourced laboratories. - Ideal as a laboratory reference or as a comprehensive exam study tool. - diagnosis, molecular testing, blood transfusion- and much more. - Complete coverage of the latest advances in the field. - An expanded section on coagulation now covers testing for new anticoagulants and includes clinical applications of the tests.
Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies
| Author | : OECD |
| Publisher | : OECD Publishing |
| Total Pages | : 447 |
| Release | : 2019-10-17 |
| Genre | : |
| ISBN | : 9264805907 |
This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.
Quality Assurance for Radioactivity Measurement in Nuclear Medicine
| Author | : International Atomic Energy Agency |
| Publisher | : IAEA |
| Total Pages | : 108 |
| Release | : 2006 |
| Genre | : Medical |
| ISBN | : |
This publication contains information on the implementation of quality assurance and quality control programmes for measuring radioactivity relating to the practice of nuclear medicine, covering standards at both the end user (clinic) and secondary radioactivity standards laboratory levels. It is based on the QA principles in ISO/IEC 17025 which describes requirements that testing and calibration laboratories must meet to demonstrate that they have a quality system in place and are technically competent.
Medical Devices and Human Engineering
| Author | : Joseph D. Bronzino |
| Publisher | : CRC Press |
| Total Pages | : 896 |
| Release | : 2014-12-17 |
| Genre | : Medical |
| ISBN | : 1439825254 |
Known 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.
Standards, Quality Control, and Measurement Sciences in 3D Printing and Additive Manufacturing
| Author | : Chee Kai Chua |
| Publisher | : Academic Press |
| Total Pages | : 270 |
| Release | : 2017-06-03 |
| Genre | : Technology & Engineering |
| ISBN | : 0128134909 |
Standards, Quality Control and Measurement Sciences in 3D Printing and Additive Manufacturing addresses the critical elements of the standards and measurement sciences in 3D printing to help readers design and create safe, reliable products of high quality. With 3D printing revolutionizing the process of manufacturing in a wide range of products, the book takes key features into account, such as design and fabrication and the current state and future potentials and opportunities in the field. In addition, the book provides an in-depth analysis on the importance of standards and measurement sciences. With self-test exercises at the end of each chapter, readers can improve their ability to take up challenges and become proficient in a number of topics related to 3D printing, including software usage, materials specification and benchmarking. - Helps the reader understand the quality framework tailored for 3D printing processes - Explains data format and process control in 3D printing - Provides an overview of different materials and characterization methods - Covers benchmarking and metrology for 3D printing
The Medical Device Industry
| Author | : Norman F. Estrin |
| Publisher | : CRC Press |
| Total Pages | : 1020 |
| Release | : 1990-08-31 |
| Genre | : Medical |
| ISBN | : 9780824782689 |
Practical 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
