Medical Devices And Ivds
DOWNLOAD
Download Medical Devices And Ivds PDF/ePub or read online books in Mobi eBooks. Click Download or Read Online button to get Medical Devices And Ivds book now. This website allows unlimited access to, at the time of writing, more than 1.5 million titles, including hundreds of thousands of titles in various foreign languages. If the content not found or just blank you must refresh this page
Medical Devices And Ivds
DOWNLOAD
Author : Wolfgang Ecker
language : en
Publisher: BoD – Books on Demand
Release Date : 2022-03-25
Medical Devices And Ivds written by Wolfgang Ecker and has been published by BoD – Books on Demand this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-03-25 with Law categories.
With this book, you get a really complete seminar for the new Regulations on medical devices and IVDs in the EU, ready at hand, at any time. These EU regulations create new rules for medical technology and laboratory diagnostics in Europe. Concise regulatory know-how is now required to keep or reposition medical devices and in vitro diagnostics on the European market, from syringes, contact lenses, medical device apps, pregnancy tests, nuclear magnetic resonance tomography to cancer tests, genetic diagnostics, HIV tests, hip implants, heart catheters, artificial spinal discs, stents and pacemakers. Concise regulatory training and further education of employees in companies and health care facilities is the order of the day. This also applies to biomedical and medical technology students at universities of applied sciences and biomedical universities, start-ups and spin-offs, who must make use of this know-how from the initial product idea through the further stages of product development to market access. The book provides a thorough, compact course on the new regulations, starting with perfect overview and easy navigation and going into depth where you need it: this book will make you fit and confident for the new European challenges!
Medical Devices And Ivds
DOWNLOAD
Author : Wolfgang Ecker
language : en
Publisher:
Release Date : 2019-02-06
Medical Devices And Ivds written by Wolfgang Ecker and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-02-06 with categories.
The new EU regulations on medical devices and in vitro diagnostic medical devices (IVDs) are changing the rules of the game in this important area of health care. It is now necessary to make use of the transitional periods and adapt quickly to the new and more demanding rules on market access. This requires a thorough knowledge of the new rules for all those responsible and employed in the sector. A sound knowledge of the new EU regulations is also indispensable for the education, training and further education of students, and staff in research and development, regulatory affairs and quality management, active in the field of medical technology, biomedical and clinical engineering, e-health and related fields. 240 pages; 35 Fig., 18 Tab.
Requirements For The Development And Use Of In House In Vitro Diagnostic Medical Devices Ivds
DOWNLOAD
Author : Department of Health and Ageing Staff
language : en
Publisher:
Release Date : 2013
Requirements For The Development And Use Of In House In Vitro Diagnostic Medical Devices Ivds written by Department of Health and Ageing Staff and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013 with categories.
Who Global Model Regulatory Framework For Medical Devices Including In Vitro Diagnostic Medical Devices
DOWNLOAD
Author : World Health Organization
language : en
Publisher:
Release Date : 2017-05-09
Who Global Model Regulatory Framework For Medical Devices Including In Vitro Diagnostic Medical Devices written by World Health Organization and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-05-09 with Law categories.
The Model recommends guiding principles and harmonized definitions and specifies the attributes of effective and efficient regulation to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF). The Model is particularly relevant for WHO Member States with little or no regulation for medical devices currently in place but with the ambition to improve this situation. It foresees that such countries will progress from basic regulatory controls towards an expanded level to the extent that their resources allow. The Model is written for the legislative, executive, and regulatory branches of government as they develop and establish a system of medical devices regulation. It describes the role and responsibilities of a country's regulatory authority for implementing and enforcing the regulations. Also, it describes circumstances in which a regulatory authority may either "rely on" or "recognize" the work products from trusted regulatory sources (such as scientific assessments, audit, and inspection reports) or from the WHO Prequalification Team. Section 2 of this document recommends definitions of the terms "medical devices" and IVDs. It describes how they may be grouped according to their potential for harm to the patient or user and specifies principles of safety and performance that the device manufacturer must adhere to. It explains how the manufacturer must demonstrate to a regulatory authority that its medical device has been designed and manufactured to be safe and to perform as intended during its lifetime. Section 3 presents the principles of good regulatory practice and enabling conditions for effectively regulating medical devices. It then introduces essential tools for regulation, explaining the function of the regulatory entity and the resources required. Section 4 presents a stepwise approach to implementing and enforcing regulatory controls for medical devices as the regulation progresses from a basic to an expanded level. It describes elements from which a country may choose according to national priorities and challenges. Also, it provides information on when the techniques of reliance and recognition may be considered and on the importance of international convergence of regulatory practice.Section 5 provides a list of additional topics to be considered when developing and implementing regulations for medical devices. It explains the relevance of these topics and provides guidance for regulatory authorities to ensure that they are addressed appropriately. The Model outlines a general approach but cannot provide country-specific guidance on implementation. While it does not offer detailed guidance on regulatory topics, it contains references to relevant documents where further information may be found. It does not detail the responsibilities of other stakeholders such as manufacturers, distributors, procurement agencies, and health-care professionals, all of whom have roles in assuring the quality, safety, and performance of medical devices.
Medical Device Regulatory Practices
DOWNLOAD
Author : Val Theisz
language : en
Publisher: CRC Press
Release Date : 2015-08-03
Medical Device Regulatory Practices written by Val Theisz and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-08-03 with Medical categories.
This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effectiv
Guideline For The Manufacture Of In Vitro Diagnostic Products
DOWNLOAD
Author :
language : en
Publisher:
Release Date : 1990
Guideline For The Manufacture Of In Vitro Diagnostic Products written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1990 with Diagnosis, Laboratory categories.
Handbook Of Medical Device Regulatory Affairs In Asia
DOWNLOAD
Author : Jack Wong
language : en
Publisher: CRC Press
Release Date : 2018-03-28
Handbook Of Medical Device Regulatory Affairs In Asia written by Jack Wong and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-03-28 with Medical categories.
Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.
The Challenges Of Conducting Medical Device Studies
DOWNLOAD
Author : Keith Summerhayes
language : en
Publisher: Inst of Clinical Research
Release Date : 2005
The Challenges Of Conducting Medical Device Studies written by Keith Summerhayes and has been published by Inst of Clinical Research this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005 with Clinical trials categories.
Describing all the regulations, guidelines and directives that affect medical device studies.
Handbook Of Medical Device Regulatory Affairs In Asia
DOWNLOAD
Author : Jack Wong
language : en
Publisher: CRC Press
Release Date : 2013-03-27
Handbook Of Medical Device Regulatory Affairs In Asia written by Jack Wong and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-03-27 with Medical categories.
Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.
Medical Device Regulations In Europe Countries N To Z
DOWNLOAD
Author :
language : en
Publisher: Global Regulatory Press
Release Date :
Medical Device Regulations In Europe Countries N To Z written by and has been published by Global Regulatory Press this book supported file pdf, txt, epub, kindle and other format this book has been release on with categories.