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Medical Devices And In Vitro Diagnostics
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Book Synopsis Medical Devices and In Vitro Diagnostics by : Christian Baumgartner
Download or read book Medical Devices and In Vitro Diagnostics written by Christian Baumgartner and published by Springer Nature. This book was released on 2023-08-26 with total page 671 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Medical Devices and in Vitro Diagnostics by : dr. Christian Baumgartner
Download or read book Medical Devices and in Vitro Diagnostics written by dr. Christian Baumgartner and published by . This book was released on 2023 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Tools for Compliance for the Medical Device and in Vitro Diagnostic Product Industries by : United States. Bureau of Medical Devices and Diagnostic Products
Download or read book Tools for Compliance for the Medical Device and in Vitro Diagnostic Product Industries written by United States. Bureau of Medical Devices and Diagnostic Products and published by . This book was released on 1976 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Book Synopsis First WHO Model List of Essential In Vitro Diagnostics by : World Health Organization
Download or read book First WHO Model List of Essential In Vitro Diagnostics written by World Health Organization and published by World Health Organization. This book was released on 2019-05-16 with total page 73 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis In vitro diagnostic medical devices by : Medical Devices Agency. Adverse Incident Centre
Download or read book In vitro diagnostic medical devices written by Medical Devices Agency. Adverse Incident Centre and published by . This book was released on 1997 with total page 1 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics by :
Download or read book Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics written by and published by World Health Organization. This book was released on 2020-12-09 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Public Health Effectiveness of the FDA 510(k) Clearance Process by : Institute of Medicine
Download or read book Public Health Effectiveness of the FDA 510(k) Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices by : World Health Organization
Download or read book WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices written by World Health Organization and published by . This book was released on 2017-05-09 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis General Requirements for in Vitro Diagnostic Medical Devices for Self-Testing by : British Standards Institute Staff
Download or read book General Requirements for in Vitro Diagnostic Medical Devices for Self-Testing written by British Standards Institute Staff and published by . This book was released on 2002-05-08 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical equipment, Diagnostic testing, Clinical investigation instruments, Diagnosis (medical), Personal health, Health and safety requirements
Book Synopsis In Vitro Diagnostic Industry in China by : Haibo Song
Download or read book In Vitro Diagnostic Industry in China written by Haibo Song and published by Springer Nature. This book was released on 2021-07-28 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book systematically describes the achievements and current situation of in vitro diagnostic (IVD) industry in China. It consists of eight parts, including the overview on the IVD industry in China in 2019, hot technologies and products of IVD industry, academic, technological and product development in the field of IVD, such as biochemical diagnosis, immune-diagnosis, molecular diagnosis, blood and body fluid diagnosis, microbial detection, point-of-care testing, laboratory assembly line, etc. This book is compiled by an editorial committee composed of well-known entrepreneurs, experts and professors in IVD industry in China. It is a reference book for practitioners of IVD industry, medical laboratory and medical staffs all over the world.
Book Synopsis In-Vitro Diagnostic Devices by : Chao-Min Cheng
Download or read book In-Vitro Diagnostic Devices written by Chao-Min Cheng and published by Springer. This book was released on 2015-07-16 with total page 111 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States by : Bernhard M. Maassen
Download or read book In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States written by Bernhard M. Maassen and published by Springer Science & Business Media. This book was released on 2013-03-09 with total page 130 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Development of National Health Laboratory Policy and Plan by : WHO Regional Office for South-East Asia
Download or read book Development of National Health Laboratory Policy and Plan written by WHO Regional Office for South-East Asia and published by . This book was released on 2011 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document provides technical support to Member States in the South-East Asia and Western Pacific Regions on the steps required to develop and effectively implement a national laboratory policy and national laboratory plan in accordance with the Asia Pacific Strategy for Strengthening Health Laboratory Services (2010-2015). The document provides a structure for developing a comprehensive policy and regulatory framework for establishing, operating and monitoring the health laboratory services, and promoting better coordination of activities among health programs and institutions for efficient support to both clinical and public health services.
Book Synopsis Medical Device Product Lifecycle by : Bernadette White
Download or read book Medical Device Product Lifecycle written by Bernadette White and published by Independently Published. This book was released on 2022-03-11 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is intended to provide an introduction to the application of a lifecycle approach to product design and development for medical devices. Medical Device Product Lifecycle management provides a framework to develop, design maintain user requirements and ensure the safety and performance of medical devices. Application of a Medical Device Product Lifecycle Management benefits the business aspects of manufacturing, fosters alignment across design and development teams and incorporates the voice of the customer, taking into account their needs and safety that is inherent in the design of products. The Medical Device Product Lifecycle (MDPL) relies upon several distinct quality management elements and processes in order to function effectively. These include; principles and establishment of a quality management system, regulatory processes, validation processes, engineering processes, change management and risk management processes. The MDPL process itself requires procedures and documentation to facilitate product realization. For the reader to gain the maximum benefit from this book, the following points should be considered. To begin with-Regulations are mandatory. Medical devices range in their application (intended use and indications), technologies, principles of operation, complexity and value. However, regulation in addition to standards need to be consulted and applied within organizations. The manufacturer has a legal responsibility in this regard and the classification and commercial strategy may require regulations such as FDA 21 CFR 820, (United States), and Medical Device Regulations EU MDR (2017/745) or Regulation 2017/746 on In-Vitro Diagnostic Devices (IVDR) (in Europe). Introduction Establishing a Medical Device Product Development Process is necessary to for medical device manufacturers to meet FDA regulations and regional regulations applicable to the products for sale. Beyond the legal stipulation, an additional purpose is to realize and deliver safe and effective medical devices that meet the intended use and user needs which provides medical solutions that enhance and preserve quality of life. To achieve safe and effective products, the guiding principles and techniques not only need to be applied in the design and development stages, but maintaining and monitoring the performance through the product lifecycle is required. It is easily to compartmentalize product performance and safety as a development and design-based activity, however, an effective medical device lifecycle process must ensure design safety and continuity until product retirement and discontinuation. The introduction of new medical device products or changes to existing medical device products necessitate design and development activities in order to plan and deliver the appropriate verifications and validations to demonstrate safety and performance of products. Device manufacturers in establishing and applying a Medical Device Product Lifecycle Process must continually ensure the process is fit-for-purpose and that is fulfils its legal and regulatory obligations (e.g. meeting the requirements of 21 CFR 820.30: Medical Devices - Quality System Regulation and ISO 13485: Medical Devices- Quality Management Systems etc.) A Medical Device Product Lifecycle process must be a comprehensive, end-to-end process that encompasses the entire life cycle of a product from project initiation through to product discontinuation and retirement of a marketed product. Making a comprehensive and detailed process intuitive and easy-to-apply should also play a role in designing and maintaining a MDPL process. Structuring the process into specific stages and the use of design review or gate reviews also provides for a format that has milestones and a stage by stage approach that makes it easier for engineers to work with.
Book Synopsis Performance Evaluation of in Vitro Diagnostic Medical Devices by : British Standards Institute Staff
Download or read book Performance Evaluation of in Vitro Diagnostic Medical Devices written by British Standards Institute Staff and published by . This book was released on 2002-05-07 with total page 18 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical equipment, Performance testing, Clinical investigation instruments, Diagnosis (medical), Patients, Diagnostic testing
Book Synopsis Clinical Evaluation of Medical Devices by : Karen Becker Witkin
Download or read book Clinical Evaluation of Medical Devices written by Karen Becker Witkin and published by Springer Science & Business Media. This book was released on 2013-03-09 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: The world is changing rapidly, and nowhere is this more apparent than in medicine. The standards are rapidly rising in the field of medical device trials. A few years ago, device developers would look askance if one told them that medical device trials and drug trials should have the same stan dards. Today, such a statement does not seem as outrageous, although there is still a large gap in the design of trials and number oftrials conducted for medical device and drug development programs. More than 20 years after the enactment of the US Medical Device Amendments, we can see that they served as an impetus to raise clinical trial standards for devices. Whether the data to establish the safety and efficacy of a device come from one, two, or even more clinical trials is less important in evaluating the device than whether the data are medically and scientifically support ive of its safety and efficacy. Having at least two separate studies, and at least two sites confirm results, adds a great deal of scientific credibility and support to a conclusion of safety and efficacy, even though a confirmatory trial is not yet a regulatory requirement in most countries.
