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Guidance For Post Market Surveillance And Market Surveillance Of Medical Devices Including In Vitro Diagnostics 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 Guidance For Post Market Surveillance And Market Surveillance Of Medical Devices Including In Vitro Diagnostics book. This book definitely worth reading, it is an incredibly well-written.
Author : Anonim
Publisher : World Health Organization
Page : 88 pages
File Size : 40,7 Mb
Release : 2020-12-09
Category : Business & Economics
ISBN : 9789240015319
Author : Anonim
Publisher : Unknown
Page : 0 pages
File Size : 40,9 Mb
Release : 2020
Category : Electronic
ISBN : OCLC:1396896285
Author : Christian Baumgartner,Johann Harer,Jörg Schröttner
Publisher : Springer Nature
Page : 671 pages
File Size : 45,9 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 : Anonim
Publisher : World Health Organization
Page : 4 pages
File Size : 43,6 Mb
Release : 2021-02-26
Category : Medical
ISBN : 9789240020207
Author : Michael Cheng,World Health Organization
Publisher : World Health Organization
Page : 54 pages
File Size : 42,5 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 : 132 pages
File Size : 44,8 Mb
Release : 2011-06-10
Category : Medical
ISBN : 9780309162067
The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already legally on the market (called a predicate), in which case the device does not need to go through the premarket approval (PMA) process. As part of its assessment of the FDA's premarket clearance process for medical devices, the Institute of Medicine (IOM) held a workshop on July 28, 2010 to discuss how medical devices are monitored for safety after they are available to consumers. Its primary focus was on monitoring the safety of marketed medical devices, including FDA's postmarket surveillance activities, analysis of safety concerns that resulted in medical device recalls, and non-FDA sources of adverse-event information. Public Health Effectiveness of the FDA 501(K) Clearance Process summarizes the views of the workshop participants.
Author : World Health Organization
Publisher : Unknown
Page : 72 pages
File Size : 43,6 Mb
Release : 2017-05-09
Category : Law
ISBN : 9241512350
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.
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 : 53,8 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 : World Health Organization
Publisher : World Health Organization
Page : 42 pages
File Size : 53,5 Mb
Release : 2022-10-13
Category : Medical
ISBN : 9789240058972
This document is a guide defining requirements for quality and safety for malaria rapid diagnostic testing services to safeguard the quality of the results, the safety of the operators and patients and that of the environment for use by national malaria control programmes, regulators, implementers and rapid diagnostic providers.
Author : Anonim
Publisher : World Health Organization
Page : 104 pages
File Size : 51,5 Mb
Release : 2021-11-18
Category : Social Science
ISBN : 9789240038462
Author : Institute of Medicine,Committee on Technological Innovation in Medicine
Publisher : National Academies Press
Page : 241 pages
File Size : 50,6 Mb
Release : 1990-02-01
Category : Medical
ISBN : 9780309042864
The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Postmarket Surveillance of Pediatric Medical Devices
Publisher : National Academies Press
Page : 481 pages
File Size : 42,8 Mb
Release : 2006-01-20
Category : Medical
ISBN : 9780309096317
Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart. Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical devices used with children. The book specifically examines: The Food and Drug Administration's monitoring and use of adverse event reports The agency's monitoring of manufacturers' fulfillment of commitments for postmarket studies ordered at the time of a device's approval for marketing The adequacy of postmarket studies of implanted devices to evaluate the effects of children's active lifestyles and their growth and development on device performance Postmarket surveillance of medical devices used with children is a little investigated topic, in part because the market for most medical products is concentrated among older adults. Yet children differ from adults, and their special characteristics have implications for evaluation and monitoring of the short- and long-term safety and effectiveness of medical devices used with young patients.
Author : World Health Organization
Publisher : World Health Organization
Page : 350 pages
File Size : 48,9 Mb
Release : 2023-05-26
Category : Medical
ISBN : 9789240074484
The 76th meeting of the WHO Expert Committee on Biological Standardization was held from 24 to 28 October 2023 by Zoom video conferencing. The meeting was opened on behalf of the Director-General of WHO by Dr Clive Ondari, Director, Health Products Policy and Standards. The Expert Committee on Biological Standardization reviews developments in the field of biological substances used in human medicine, which include vaccines, biotherapeutics, blood products and related substances, and in vitro diagnostic reagents. It coordinates activities leading to: (a) the adoption of WHO guidelines and recommendations for assuring the quality, safety and efficacy of such substances; and (b) the establishment of WHO international standards and other reference materials. The use of international reference materials for designating the activity of biological substances used in prophylaxis or therapy, or for ensuring the reliability of quality control or diagnostic procedures, allows for the comparison of data worldwide. Target audience includes - but is not limited to - regulators, manufacturers, policymakers, health workers, developers of vaccines and other biological products and academia.
Author : World Health Organization
Publisher : World Health Organization
Page : 63 pages
File Size : 45,7 Mb
Release : 2023-10-19
Category : Medical
ISBN : 9789240082496
This document outlines the concept and content of the WHO people-centred approach to addressing antimicrobial resistance (AMR) in the human health sector. The proposed approach recognizes and aims to address the challenges and health system barriers people face when accessing health services to prevent, diagnose and treat (drug-resistant) infections. It puts people and their needs at the centre of the AMR response and guides policy-makers in taking programmatic and comprehensive actions to mitigate AMR in line with a proposed package of core interventions. These interventions are based on a review of four pillars and two foundational steps that are critical to overcome barriers faced by people and health systems in addressing AMR. The four pillars are: (1) prevention of infections; (2) access to essential health services; (3) timely, accurate diagnosis; and (4) appropriate, quality-assured treatment. The pillars are supported by the two foundational steps: effective governance, awareness and education; and strategic information through surveillance and research. Building and adding on to the objectives of the Global action plan on AMR, the 13 core interventions and accompanying priority actions are designed to address AMR in a programmatic manner that puts people, their needs and equitable access to health services at the centre of the AMR response in the community, in primary care, secondary and tertiary care, and at national and/or subnational level. The development of the people-centred core package of AMR interventions was based on a review of the evidence and multidisciplinary expert opinion, complemented with feedback from a global online consultation and WHO’s strategic and technical advisory group on antimicrobial resistance. As countries develop or revise their national action plans (NAPs) on AMR, the people-centred core package of interventions can support the design and prioritization of actions in the human health sector at the different levels of implementation and integrated with broader health system strengthening and pandemic preparedness and response plans.
Author : Anonim
Publisher : World Health Organization
Page : 80 pages
File Size : 42,6 Mb
Release : 2022-02-28
Category : Medical
ISBN : 9789240041981
In 2015 the World Health Assembly endorsed the Global action plan on antimicrobial resistance calling on countries to develop and implement national action plans on antimicrobial resistance (AMR). For most countries, the greatest challenge is not developing a national action plan; rather, it is the implementation of the plan based on evidence-based prioritization of activities, systematic monitoring of progress, and ensuring sustainability of efforts. The purpose of this publication is to to provide a practical, stepwise approach to the implementation of the national action plan on AMR within the human health sector; and to provide a process and collation of existing WHO tools to prioritize, cost, implement, monitor and evaluate national action plan activities. The target audience of the publication are national/subnational stakeholders working on AMR within the human health sector. This includes national health authorities, national multisectoral coordination groups, senior technical experts and policymakers involved in implementing AMR activities at all levels of the health system, and implementation partners to accelerate sustainable implementation and monitoring and evaluation of national action plans on AMR.
