Medical Device Regulations PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Medical Device Regulations PDF full book. Access full book title Medical Device Regulations by Michael Cheng. Download full books in PDF and EPUB format.
Author: Michael Cheng
Publisher: World Health Organization
ISBN: 9241546182
Category : Medical
Languages : en
Pages : 54
Get Book Here
Book Description
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: Michael Cheng
Publisher: World Health Organization
ISBN: 9241546182
Category : Medical
Languages : en
Pages : 54
Get Book Here
Book Description
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: David A. Vogel
Publisher: Artech House
ISBN: 1596934239
Category : Medical
Languages : en
Pages : 445
Get Book Here
Book Description
HereOCOs the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your softwareOCOs safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process.From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, in compliance with regulations."
Author: Michael J. McGrath
Publisher: Apress
ISBN: 1430260149
Category : Computers
Languages : en
Pages : 321
Get Book Here
Book Description
Sensor Technologies: Healthcare, Wellness and Environmental Applications explores the key aspects of sensor technologies, covering wired, wireless, and discrete sensors for the specific application domains of healthcare, wellness and environmental sensing. It discusses the social, regulatory, and design considerations specific to these domains. The book provides an application-based approach using real-world examples to illustrate the application of sensor technologies in a practical and experiential manner. The book guides the reader from the formulation of the research question, through the design and validation process, to the deployment and management phase of sensor applications. The processes and examples used in the book are primarily based on research carried out by Intel or joint academic research programs. “Sensor Technologies: Healthcare, Wellness and Environmental Applications provides an extensive overview of sensing technologies and their applications in healthcare, wellness, and environmental monitoring. From sensor hardware to system applications and case studies, this book gives readers an in-depth understanding of the technologies and how they can be applied. I would highly recommend it to students or researchers who are interested in wireless sensing technologies and the associated applications.” Dr. Benny Lo Lecturer, The Hamlyn Centre, Imperial College of London “This timely addition to the literature on sensors covers the broad complexity of sensing, sensor types, and the vast range of existing and emerging applications in a very clearly written and accessible manner. It is particularly good at capturing the exciting possibilities that will occur as sensor networks merge with cloud-based ‘big data’ analytics to provide a host of new applications that will impact directly on the individual in ways we cannot fully predict at present. It really brings this home through the use of carefully chosen case studies that bring the overwhelming concept of 'big data' down to the personal level of individual life and health.” Dermot Diamond Director, National Centre for Sensor Research, Principal Investigator, CLARITY Centre for Sensor Web Technologies, Dublin City University "Sensor Technologies: Healthcare, Wellness and Environmental Applications takes the reader on an end-to-end journey of sensor technologies, covering the fundamentals from an engineering perspective, introducing how the data gleaned can be both processed and visualized, in addition to offering exemplar case studies in a number of application domains. It is a must-read for those studying any undergraduate course that involves sensor technologies. It also provides a thorough foundation for those involved in the research and development of applied sensor systems. I highly recommend it to any engineer who wishes to broaden their knowledge in this area!" Chris Nugent Professor of Biomedical Engineering, University of Ulster
Author: World Health Organization
Publisher:
ISBN: 9789241512350
Category : Law
Languages : en
Pages : 72
Get Book Here
Book Description
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: Stephen F. Amato
Publisher: Elsevier
ISBN: 0857099205
Category : Technology & Engineering
Languages : en
Pages : 203
Get Book Here
Book Description
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: Jayet Moon
Publisher: Quality Press
ISBN: 1636941729
Category : Business & Economics
Languages : en
Pages : 195
Get Book Here
Book Description
When it comes to medical and in vitro devices, risk management starts with a design assurance process that helps practitioners identify, understand, analyze, and mitigate the risks of the healthcare product design for favorable benefit-risk assessment. Risk management actively follows the product’s life cycle into production and post-market phases. This book offers a blueprint for implementing an effective risk management system. It provides risk management tools and a compliance framework for methods in conformance to ISO 13485:2016, ISO 14971:2019, European Union MDR, IVDR, and US FDA regulations (including the new FDA QMSR).
Author: Dean Leffingwell
Publisher: Addison-Wesley Professional
ISBN: 9780201615937
Category : Computers
Languages : en
Pages : 532
Get Book Here
Book Description
A classic treatise that defined the field of applied demand analysis, Consumer Demand in the United States: Prices, Income, and Consumption Behavior is now fully updated and expanded for a new generation. Consumption expenditures by households in the United States account for about 70% of Americaâ__s GDP. The primary focus in this book is on how households adjust these expenditures in response to changes in price and income. Econometric estimates of price and income elasticities are obtained for an exhaustive array of goods and services using data from surveys conducted by the Bureau of Labor Statistics, providing a better understanding of consumer demand. Practical models for forecasting future price and income elasticities are also demonstrated. Fully revised with over a dozen new chapters and appendices, the book revisits the original Taylor-Houthakker models while examining new material as well, such as the use of quantile regression and the stationarity of consumer preference. It also explores the emerging connection between neuroscience and consumer behavior, integrating the economic literature on demand theory with psychology literature. The most comprehensive treatment of the topic to date, this volume will be an essential resource for any researcher, student or professional economist working on consumer behavior or demand theory, as well as investors and policymakers concerned with the impact of economic fluctuations.
Author:
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 0
Get Book Here
Book Description
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle. This document does not apply to: decisions on the use of a medical device in the context of any particular clinical procedure; or business risk management. This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels. Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place. NOTE Guidance on the application of this document can be found in ISO/TR 24971-- Scope, page 1.
Author: Susan Neadle
Publisher: CRC Press
ISBN: 1000874583
Category : Medical
Languages : en
Pages : 439
Get Book Here
Book Description
Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.
Author: Jane Huang
Publisher: Springer Science & Business Media
ISBN: 1447122380
Category : Computers
Languages : en
Pages : 495
Get Book Here
Book Description
Software and Systems Traceability provides a comprehensive description of the practices and theories of software traceability across all phases of the software development lifecycle. The term software traceability is derived from the concept of requirements traceability. Requirements traceability is the ability to track a requirement all the way from its origins to the downstream work products that implement that requirement in a software system. Software traceability is defined as the ability to relate the various types of software artefacts created during the development of software systems. Traceability relations can improve the quality of a product being developed, and reduce the time and cost of development. More specifically, traceability relations can support evolution of software systems, reuse of parts of a system by comparing components of new and existing systems, validation that a system meets its requirements, understanding of the rationale for certain design and implementation decisions, and analysis of the implications of changes in the system.
