Download Full eBooks in PDF
General Requirements For In Vitro Diagnostic Medical Devices For Self Testing Book in PDF, ePub and Kindle version is available to download in english. Read online anytime anywhere directly from your device. Click on the download button below to get a free pdf file of General Requirements For In Vitro Diagnostic Medical Devices For Self Testing book. This book definitely worth reading, it is an incredibly well-written.
Author : British Standards Institute Staff
Publisher : Unknown
Page : 12 pages
File Size : 44,5 Mb
Release : 2002-05-08
Category : Electronic
ISBN : 0580396827
Medical equipment, Diagnostic testing, Clinical investigation instruments, Diagnosis (medical), Personal health, Health and safety requirements
Author : World Health Organization
Publisher : World Health Organization
Page : 73 pages
File Size : 44,7 Mb
Release : 2019-05-16
Category : Medical
ISBN : 9789241210263
The objective of the list is to help countries develop or update their national essential diagnostics lists, raise awareness and political will, guide procurement and regulation policies and improve access to the most important in vitro diagnostics that all countries need to make available to their populations, particularly in low-resourced countries. It will also contribute towards health systems strengthening and realizing universal health coverage.
Author : British Standards Institute Staff
Publisher : Unknown
Page : 62 pages
File Size : 45,8 Mb
Release : 1911-10-31
Category : Electronic
ISBN : 0580773272
Diagnosis (medical), Medical equipment, Product information, Instructions for use, Labels, Labelling (process), Clinical investigation instruments, Diagnostic reagents, Clinical laboratory equipment, Reagent solutions, Definitions, Measurement
Author : British Standards Institute Staff
Publisher : Unknown
Page : 18 pages
File Size : 40,9 Mb
Release : 2002-05
Category : Electronic
ISBN : 0580396517
Medical equipment, Medical instruments, Diagnosis (medical), Clinical investigation instruments, Reagent solutions, Chemical reagents, Instructions for use
Author : British Standards Institute Staff
Publisher : Unknown
Page : 30 pages
File Size : 54,6 Mb
Release : 2009-05-31
Category : Electronic
ISBN : 0580928993
Medical equipment, Diagnosis (medical), Clinical investigation instruments, Biological analysis and testing, Measurement, Samples, Documents, Layout, Safety measures, Terminology, Calibration, Data processing, Statistical methods of analysis, Reliability, Precision, Accuracy, Reproducibility, Quality assurance, Laboratories
Author : British Standards Institute Staff
Publisher : Unknown
Page : 14 pages
File Size : 47,5 Mb
Release : 2002-05
Category : Electronic
ISBN : 0580396525
Medical instruments, Medical equipment, Clinical investigation instruments, Diagnosis (medical), Instructions for use
Author : Michael Cheng,World Health Organization
Publisher : World Health Organization
Page : 54 pages
File Size : 49,5 Mb
Release : 2003-09-16
Category : Medical
ISBN : 9789241546188
The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publisher : National Academies Press
Page : 141 pages
File Size : 45,6 Mb
Release : 2010-10-04
Category : Medical
ISBN : 9780309162906
The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.
Author : Pedro Borralho,Fernando Schmitt,Liang Wang,Umberto Malapelle
Publisher : Frontiers Media SA
Page : 279 pages
File Size : 41,9 Mb
Release : 2023-04-05
Category : Science
ISBN : 9782832518373
Author : Carl A. Burtis,Edward R. Ashwood,David E. Bruns
Publisher : Elsevier Health Sciences
Page : 2259 pages
File Size : 44,6 Mb
Release : 2011-12-16
Category : Medical
ISBN : 9781455759422
As the definitive reference for clinical chemistry, Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 5th Edition offers the most current and authoritative guidance on selecting, performing, and evaluating results of new and established laboratory tests. Up-to-date encyclopedic coverage details everything you need to know, including: analytical criteria for the medical usefulness of laboratory procedures; new approaches for establishing reference ranges; variables that affect tests and results; the impact of modern analytical tools on lab management and costs; and applications of statistical methods. In addition to updated content throughout, this two-color edition also features a new chapter on hemostasis and the latest advances in molecular diagnostics. Section on Molecular Diagnostics and Genetics contains nine expanded chapters that focus on emerging issues and techniques, written by experts in field, including Y.M. Dennis Lo, Rossa W.K. Chiu, Carl Wittwer, Noriko Kusukawa, Cindy Vnencak-Jones, Thomas Williams, Victor Weedn, Malek Kamoun, Howard Baum, Angela Caliendo, Aaron Bossler, Gwendolyn McMillin, and Kojo S.J. Elenitoba-Johnson. Highly-respected author team includes three editors who are well known in the clinical chemistry world. Reference values in the appendix give you one location for comparing and evaluating test results. NEW! Two-color design throughout highlights important features, illustrations, and content for a quick reference. NEW! Chapter on hemostasis provides you with all the information you need to accurately conduct this type of clinical testing. NEW! Six associate editors lend even more expertise and insight to the reference. NEW! Reorganized chapters ensure that only the most current information is included.
Author : Christian Baumgartner,Johann Harer,Jörg Schröttner
Publisher : Springer Nature
Page : 671 pages
File Size : 43,6 Mb
Release : 2023-08-26
Category : Technology & Engineering
ISBN : 9783031220913
This updatable reference work gives a comprehensive overview of all relevant regulatory information and requirements for manufacturers and distributors around medical and in-vitro diagnostic devices in Europe. These individual requirements are presented in a practice-oriented manner, providing the reader with a concrete guide to implementation with main focus on the EU medical device regulations, such as MDR 2017/745 and IVD-R 2017/746, and the relevant standards, such as the ISO 13485, ISO 14971, among others. This book offers a good balance of expert knowledge, empirical values and practice-proven methods. Not only it provides readers with a quick overview about the most important requirements in the medical device sector, yet it shows concrete and proven ways in which these requirements can be implemented in practice. It addresses medical manufacturing companies, professionals in development, production, and quality assurance departments, and technical and medical students who are preparing themselves for a professional career in the medical technlogy industries.
Author : Barbara J. Bain,Imelda Bates,Mike A Laffan
Publisher : Elsevier Health Sciences
Page : 600 pages
File Size : 41,6 Mb
Release : 2016-08-11
Category : Medical
ISBN : 9780702069253
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. Each templated, easy-to-follow chapter has been completely updated, featuring new information on haematological 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.
Author : World Health Organization
Publisher : World Health Organization
Page : 40 pages
File Size : 50,6 Mb
Release : 2021-09-01
Category : Medical
ISBN : 9789240033757
Author : World Health Organization
Publisher : World Health Organization
Page : 236 pages
File Size : 44,8 Mb
Release : 2019-11-21
Category : Medical
ISBN : 9789241210317
The report of the second meeting of the Strategic Advisory Group of Experts on In Vitro was launched in November 2019 and includes the updated WHO Model List of Essential In Vitro Diagnostics (EDL), which lists 122 in vitro diagnostic categories and incorporates evidence base and expositions of the applications to be included on the EDL and the basis of decisions made to list or reject these IVDs. The evidence is expected to guide countries on constituting their national EDLs. In addition the report also presents decision summaries on suggested edits to the first EDL, recommendations on various matters of in vitro diagnostics including the framework for developing future editions, and proposed actions for implementation of the EDL in regions and countries.
Author : Pronobesh Chattopadhyay,Danswrang Goyary
Publisher : CRC Press
Page : 263 pages
File Size : 43,6 Mb
Release : 2024-05-02
Category : Medical
ISBN : 9781040018385
Modern Medicine: Biomedical Devices, Medical Gases, Radiopharmaceuticals, New Drug Discovery, Volume 2 discusses the procedures of drug approval and regulatory requirements that must be met according to the United States Food and Drug Administration (FDA), the European Medical Agency (EMA), and the Central Drug Standard Control Organization (CDSCO). In the rapidly evolving landscape of modern medicine, groundbreaking innovations have emerged that are reshaping the way we approach healthcare. Modern Medicine delves into the cutting-edge realms of medical devices, medical gases, radiopharmaceuticals, and new drug discovery, offering a comprehensive exploration of these transformative fields that are revolutionizing patient care and medical practices. Discover the future of healthcare technology, and uncover the intricate world of biomedical engineering, where state-of-the-art devices seamlessly merge with the human body to monitor, diagnose, and treat ailments Dive deep into the utilization of medical gases for respiratory conditions, pain management, and even novel applications in regenerative medicine Unravel the mysteries of radiopharmaceuticals, a fusion of molecular imaging and therapy that offers unprecedented insights into the inner workings of the human body Embark on a journey through the intricate processes of drug discovery, where groundbreaking research and cutting-edge technologies are yielding therapies that were once deemed impossible Modern Medicine is a must-read for medical professionals, researchers, students, and anyone intrigued by the remarkable intersection of science, technology, and patient well-being. Join us on a journey to the forefront of medical innovation, where the unimaginable becomes reality, and the future of healthcare takes shape before our eyes. The chapter on regulatory implications for the approval process in this book will be the most useful resource for researchers and students, particularly those with backgrounds in pharma, forensic medicine, regulatory affairs, or those who aspire to succeed in drug research. Additionally, the information contained in this volume of the book could be of great interest to researchers working in the pharmaceutical and health industries.
