Download or read book Guide to Distributors of Medical Equipment and Supplies Worldwide March 2011 written by Espicom Business Intelligence and published by . This book was released on 2011 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Guide to Distributors of Medical Equipment and Supplies Worldwide 2008 written by and published by . This book was released on 2008-01-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
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.
Download or read book Medical Devices written by World Health Organization and published by World Health Organization. This book was released on 2010 with total page 147 pages. Available in PDF, EPUB and Kindle. Book excerpt: Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9
Download or read book Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation written by Orlando Lopez and published by Taylor & Francis. This book was released on 2018-10-02 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.
Download or read book Plunkett s Health Care Industry Almanac written by Jack W. Plunkett and published by Plunkett Research, Ltd.. This book was released on 2008-10 with total page 734 pages. Available in PDF, EPUB and Kindle. Book excerpt: This acclaimed and popular text is the only complete market research guide to the American health care industry--a tool for strategic planning, competitive intelligence, employment searches or financial research. Covers national health expenditures, technologies, patient populations, research, Medicare, Medicaid, managed care. Contains trends, statistical tables and an in-depth glossary. Features in-depth profiles of the 500 major firms in all health industry sectors.
Download or read book EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP written by Orlando Lopez and published by CRC Press. This book was released on 2015-04-06 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems.The purpose of Annex 11 is
Download or read book Dietary Supplements written by United States. Federal Trade Commission. Bureau of Consumer Protection and published by . This book was released on 1998 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book WHO List of Priority Medical Devices for Cancer Management written by World Health Organization and published by . This book was released on 2017-05-09 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the model list and clearing house of appropriate, basic, and priority medical devices based on the list of clinical interventions selected from clinical guidelines on prevention, screening, diagnosis, treatment, palliative care, monitoring, and end of life care. This publication addresses medical devices that can be used for the management of cancer and specifically describes medical devices for six types of cancer: breast, cervical, colorectal, leukemia, lung, and prostate. This book is intended for ministries of health, public health planners, health technology managers, disease management, researchers, policy makers, funding, and procurement agencies and support and advocacy groups for cancer patients.
Download or read book Medical Supply Catalog written by Health and Human Services Supply Service Center (U.S.) and published by . This book was released on 1996* with total page 506 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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.
Download or read book The British National Bibliography written by Arthur James Wells and published by . This book was released on 2009 with total page 2744 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Plastics in Medical Devices for Cardiovascular Applications written by Ajay Padsalgikar and published by William Andrew. This book was released on 2017-02-01 with total page 198 pages. Available in PDF, EPUB and Kindle. Book excerpt: Plastics in Medical Devices for Cardiovascular Applications enables designers of new cardiovascular medical devices to make decisions about the kind of plastics that can go into the manufacture of their device by explaining the property requirements of various applications in this area, including artificial valves, lead insulation, balloons, vascular grafts, and more. - Enables designers to improve device performance and remain compliant with regulations by selecting the best material for each application - Presents a range of applications, including artificial valves, stents, and vascular grafts - Explains which materials can be used for each application, and why each is appropriate, thus assisting in the design of better tools and processes
Download or read book Plunkett s Entertainment Media Industry Almanac written by Jack W. Plunkett and published by Plunkett Research, Ltd.. This book was released on 2009-01-22 with total page 591 pages. Available in PDF, EPUB and Kindle. Book excerpt: Offers profiles on many of firms in film, radio, television, cable, media, and publishing of various types including books, magazines and newspapers. This book contains many contacts for business and industry leaders, industry associations, Internet sites and other resources. It provides profiles of nearly 400 of top entertainment and media firms.
Download or read book Supply Chain Risk Management written by Yacob Khojasteh and published by Springer. This book was released on 2017-07-24 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers important issues related to managing supply chain risks from various perspectives. Supply chains today are vulnerable to disruptions with a significant impact on firms’ business and performance. The aim of supply chain risk management is to identify the potential sources of risks and implement appropriate actions in order to mitigate supply chain disruptions. This book presents a set of models, frameworks, strategies, and analyses that are essential for managing supply chain risks. As a comprehensive collection of the latest research and most recent cutting-edge developments on supply chain risk and its management, the book is structured into three main parts: 1) Supply Chain Risk Management; 2) Supply Chain Vulnerability and Disruptions Management; and 3) Toward a Resilient Supply Chain. Leading academic researchers as well as practitioners have contributed chapters, combining theoretical findings and research results with a practical and contemporary view on how companies can manage the supply chain risks and disruptions, as well as how to create a resilient supply chain. This book can serve as an essential source for students and scholars who are interested in pursuing research or teaching courses in the rapidly growing area of supply chain risk management. It can also provide an interesting and informative read for managers and practitioners who need to deepen their knowledge of effective supply chain risk management.
Download or read book Implementation Research in Health written by David H. Peters and published by World Health Organization. This book was released on 2013 with total page 69 pages. Available in PDF, EPUB and Kindle. Book excerpt: Interest in implementation research is growing, largely in recognition of the contribution it can make to maximizing the beneficial impact of health interventions. As a relatively new and, until recently, rather neglected field within the health sector, implementation research is something of an unknown quantity for many. There is therefore a need for greater clarity about what exactly implementation research is, and what it can offer. This Guide is designed to provide that clarity. Intended to support those conducting implementation research, those with responsibility for implementing programs, and those who have an interest in both, the Guide provides an introduction to basic implementation research concepts and language, briefly outlines what it involves, and describes the many opportunities that it presents. The main aim of the Guide is to boost implementation research capacity as well as demand for implementation research that is aligned with need, and that is of particular relevance to health systems in low- and middle-income countries (LMICs). Research on implementation requires the engagement of diverse stakeholders and multiple disciplines in order to address the complex implementation challenges they face. For this reason, the Guide is intended for a variety of actors who contribute to and/or are impacted by implementation research. This includes the decision-makers responsible for designing policies and managing programs whose decisions shape implementation and scale-up processes, as well as the practitioners and front-line workers who ultimately implement these decisions along with researchers from different disciplines who bring expertise in systematically collecting and analyzing information to inform implementation questions. The opening chapters (1-4) make the case for why implementation research is important to decision-making. They offer a workable definition of implementation research and illustrate the relevance of research to problems that are often considered to be simply administrative and provide examples of how such problems can be framed as implementation research questions. The early chapters also deal with the conduct of implementation research, emphasizing the importance of collaboration and discussing the role of implementers in the planning and designing of studies, the collection and analysis of data, as well as in the dissemination and use of results. The second half of the Guide (5-7) detail the various methods and study designs that can be used to carry out implementation research, and, using examples, illustrates the application of quantitative, qualitative, and mixed-method designs to answer complex questions related to implementation and scale-up. It offers guidance on conceptualizing an implementation research study from the identification of the problem, development of research questions, identification of implementation outcomes and variables, as well as the selection of the study design and methods while also addressing important questions of rigor.
Download or read book Spain Investment and Business Guide Volume 1 Strategic and Practical Information written by IBP USA and published by Lulu.com. This book was released on 2013-08 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: Spain Investment and Business Guide - Strategic and Practical Information
