Download Full eBooks in PDF
Instructions For Use For In Vitro Diagnostic Instruments 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 Instructions For Use For In Vitro Diagnostic Instruments For Self Testing book. This book definitely worth reading, it is an incredibly well-written.
Author : British Standards Institute Staff
Publisher : Unknown
Page : 14 pages
File Size : 51,6 Mb
Release : 2002-05
Category : Electronic
ISBN : 0580396525
Medical instruments, Medical equipment, Clinical investigation instruments, Diagnosis (medical), Instructions for use
Author : British Standards Institute Staff
Publisher : Unknown
Page : 18 pages
File Size : 49,8 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 : 14 pages
File Size : 46,6 Mb
Release : 2001-05
Category : Electronic
ISBN : 0580372324
Diagnosis (medical), Clinical investigation instruments, Medical sciences, Instructions for use
Author : British Standards Institute Staff
Publisher : Unknown
Page : 12 pages
File Size : 53,8 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 : Stephen F. Amato,Robert M. Ezzell Jr
Publisher : Elsevier
Page : 202 pages
File Size : 46,9 Mb
Release : 2014-10-27
Category : Medical
ISBN : 9780857099204
All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. Addresses global regulations and regulatory issues surrounding biomaterials and medical devices Especially useful for smaller companies who may not employ a full time vigilance professional Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing
Author : Barbara J. Bain,Imelda Bates,Mike A Laffan
Publisher : Elsevier Health Sciences
Page : 600 pages
File Size : 54,6 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 : John J. Tobin,Gary Walsh
Publisher : John Wiley & Sons
Page : 304 pages
File Size : 43,6 Mb
Release : 2011-08-24
Category : Science
ISBN : 9783527644711
Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.
Author : Pronobesh Chattopadhyay,Danswrang Goyary
Publisher : CRC Press
Page : 263 pages
File Size : 42,5 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.
Author : World Health Organization
Publisher : World Health Organization
Page : 40 pages
File Size : 47,6 Mb
Release : 2021-09-01
Category : Medical
ISBN : 9789240033757
Author : A. Victor Hoffbrand,Daniel Catovsky,Edward G. D. Tuddenham
Publisher : John Wiley & Sons
Page : 1091 pages
File Size : 45,7 Mb
Release : 2008-04-15
Category : Medical
ISBN : 9781405143530
"Most hematologists need a revised and practical textbook in whichthey can rapidly search on the morning of a consultation...Thisbook will be an important resource in suchsituations." New England Journal of Medicine A well established and respected review ofhematology Postgraduate Haematology is a practical, readable text whichwill give trainees, residents and practising hematologistsup-to-date knowledge of the pathogenesis, clinical and laboratoryfeatures and management of blood disorders. Postgraduate Haematology is ideal for: Trainees and residents in hematology Hematologists in practice Why Buy This Book? A well established and respected review ofhematology Practical and readable text Essential information for everyday use as well as thescientific background Up-to-date knowledge of the pathogenesis, clinical andlaboratory features and management of blood disorders Complete revision of all chapters and the addition of newchapters to reflect latest advances in the speciality
Author : Chao-Min Cheng,Chen-Meng Kuan,Chien-Fu Chen
Publisher : Springer
Page : 106 pages
File Size : 54,5 Mb
Release : 2015-07-16
Category : Technology & Engineering
ISBN : 9783319197371
Addressing the origin, current status, and future development of point-of-care diagnostics, and serving to integrate knowledge and tools from Analytical Chemistry, Bioengineering, Biomaterials, and Nanotechnology, this book focusses on addressing the collective and combined needs of industry and academia (including medical schools) to effectively conduct interdisciplinary research. In addition to summarizing and detailing developed diagnostic devices, this book will attempt to point out the possible future trends of development for point-of-care diagnostics using both scientifically based research and practical engineering needs with the aim to help novices comprehensively understand the development of point-of-care diagnostics. This includes demonstrating several common but critical principles and mechanisms used in point-of-care diagnostics that address practical needs (e.g., disease or healthcare monitoring) using two well-developed examples so far: 1) blood glucose meters (via electrochemistry); and, 2) pregnancy tests (via lateral flow assay). Readers of this book will come to fully comprehend how to develop point-of-care diagnostics devices, and will be inspired to contribute to a critical global cause – the development of inexpensive, effective, and portable in vitro diagnostics tools (for any purpose) that can be used either at home or in resource limited areas.
Author : Bernhard M. Maassen,R. Whaite
Publisher : Springer Science & Business Media
Page : 130 pages
File Size : 53,9 Mb
Release : 2013-03-09
Category : Law
ISBN : 9789401583190
Preface by T. Morrison, Director-General of the European Diagnostic Manufacturers Association. Contributors: W. Kewenig; G. Forlani, J. Marriage, G. Ulloa This book is based upon a report prepared at the request of the European Commission. Its purpose is to set out the existing laws regulating the development, production, distribution and use of in vitro diagnostic medical devices (IVDMD) in the U.K., Germany, France, Italy and Spain. Each national section has the same structure and covers the same ground in order to enable comparisons. IVDM Devices includes not only reagents, but also technical instruments, or combination of both, for human use. The book is directed towards industry and the regulation is covered with a high degree of specificity. This reference book, completely written in English, is the only comprehensive exposition of the laws of the five countries regarding IVDM Devices available. It is also the most convenient means of comparing those laws. As such, it will be a useful guide to all IVDM Devices manufacturers interested in the European market.
Author : ECRI Institute Staff,Ecri
Publisher : Ecri
Page : 3384 pages
File Size : 51,6 Mb
Release : 2007-12
Category : Electronic
ISBN : 0977914275
Author : World Health Organization
Publisher : World Health Organization
Page : 35 pages
File Size : 42,6 Mb
Release : 2023-11-23
Category : Medical
ISBN : 9789240082939
Author : Sally Shorthose
Publisher : Kluwer Law International B.V.
Page : 589 pages
File Size : 42,6 Mb
Release : 2017-02-17
Category : Law
ISBN : 9789041170026
In the European Union (EU) and its Member States, as elsewhere, the marketing of pharmaceuticals has become subject to an increasingly complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but safe. This useful volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage. A brief overview of how the proposed exit from the EU by the UK will affect the regulatory regime is also included. Following an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of fifteen incisive chapters examines a particular process or subject. Among the many topics and issues covered are the following: - obtaining a marketing authorisation; - stages and standards for creating a product dossier; - clinical trials; - how and when an abridged procedure can be used; - criteria for conditional marketing authorisations; - generic products and ‘essential similarity’; - paediatric use and the requisite additional trials; - biologicals and ‘biosimilars’; - homeopathic and herbal medicines; - reporting procedures; - pharmacovigilance; - parallel trade; - relevant competition law and intellectual property rights; and - advertising. In addition, national variation charts in many of the chapters illustrate eight major jurisdictions (Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden, and the UK). Sample forms and URLs for the most important Directives are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.