Author: Seeram Ramakrishna
Publisher: Woodhead Publishing
ISBN: 0081002912
Category : Medical
Languages : en
Pages : 253
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Book Description
Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors’ practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. Provides readers with a global perspective on medical device regulations Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards Includes a useful case study demonstrating the design and approval process
Author: Aakash Deep
Publisher: Academic Press
ISBN: 0323911277
Category : Technology & Engineering
Languages : en
Pages : 187
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Book Description
Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers the registration procedures of medical devices for pharmaceutical regulatory organizations. Sections provide guidance on dealing with the ethical considerations of medical device development, compliance with patient confidentiality using information from medical devices, the interoperability between, and among devices outside of healthcare, and the dynamics of implementation of new devices to ensure patient safety. The author brings forth relevant issues, challenges and demonstrates how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom-line by demystifying the regulatory impact on operational requirements. Provides clear information on regulatory pathways for the design and commercialization of Medical Devices in different countries Explains the difference between standards and mandatory regulations for each region, along with discussions of regulations from USFDA (USA), CDSCO (India), EMEA (European Union), SFDA (China) and PMDA (Japan) Compiles regulations for medical devices and pharmaceuticals worldwide, helping readers create globally compliant products
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309162904
Category : Medical
Languages : en
Pages : 141
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Book Description
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: Michael Cheng
Publisher: Diamond Pocket Books (P) Ltd.
ISBN: 9789241546188
Category : Medical
Languages : en
Pages : 58
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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: Prakash Srinivasan Timiri Shanmugam
Publisher: Springer Nature
ISBN: 3030918556
Category : Technology & Engineering
Languages : en
Pages : 382
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Book Description
This comprehensive resource features in-depth discussions of important guidelines and regulations needed to understand and properly meet medical device code-related requirements. Focusing on the practical application of the regulations, the Medical Device Guidelines and Regulations Handbook delivers clear explanations, real-world examples, and annotation on the applicable provisions that will allow you to safely and confidently choose materials and processes for medical device development, testing, and manufacturing. A critical resource for researchers and professionals in the medical device field; Thoroughly covers ISO 10993, ISO 22442, ISO 14971, ISO 13485, ISO 21534, REACH, RoHS, CLP, EU MDR; Presents simplified guidelines and regulation points.
Author: Amiram Daniel
Publisher: Quality Press
ISBN: 0873897404
Category : Medical
Languages : en
Pages : 355
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Book Description
How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes an update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs.
Author: Des O'Brien
Publisher: Createspace Independent Publishing Platform
ISBN: 9781978202955
Category :
Languages : en
Pages : 112
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Book Description
For the Engineer or scientist starting out in Medical devices, the array of regulation across the globe can be daunting. Many companies also need to fulfill regulation from multiple jurisdictions. Some requirements of Design, GMP and manufacturing are common. FDA and European market requires provide a framework for medical device manufacturers to certain requirements that ensure patient safety. This short book introduces the key themes associated with Medical Device Regulation. While the online world provides a detailed and perrinial source of current information and regulations, it is often hard to know where to start. This concise book provides that introduction and provides in a physical format that is a useful companion for the Engineer or Medical Device Professional. (Page Count 112)
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309156297
Category : Medical
Languages : en
Pages : 322
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Book Description
The rapid growth of home health care has raised many unsolved issues and will have consequences that are far too broad for any one group to analyze in their entirety. Yet a major influence on the safety, quality, and effectiveness of home health care will be the set of issues encompassed by the field of human factors research-the discipline of applying what is known about human capabilities and limitations to the design of products, processes, systems, and work environments. To address these challenges, the National Research Council began a multidisciplinary study to examine a diverse range of behavioral and human factors issues resulting from the increasing migration of medical devices, technologies, and care practices into the home. Its goal is to lay the groundwork for a thorough integration of human factors research with the design and implementation of home health care devices, technologies, and practices. On October 1 and 2, 2009, a group of human factors and other experts met to consider a diverse range of behavioral and human factors issues associated with the increasing migration of medical devices, technologies, and care practices into the home. This book is a summary of that workshop, representing the culmination of the first phase of the study.
Author: Dyadem Press
Publisher: CRC Press
ISBN: 0203009681
Category : Technology & Engineering
Languages : en
Pages : 143
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Book Description
These guidelines form a comprehensive overview of Failure Mode and Effects Analysis (FMEA) and examines why FMEA has become a powerful and respected analytical technique for effectively managing and reducing risks. Readers learn how to use FMEA throughout the life cycles of their product to improve customer satisfaction and assure safety and regulatory compliance. They will obtain sound advice on selecting a study team, setting up and conducting a study, and analyzing the results. Other topics include Failure Mode, Effects, and Criticality Analysis, Risk Management Planning, Advanced Quality Planning, Product Quality Control Plans, and Dynamic Control Plans.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212456
Category : Medical
Languages : en
Pages : 318
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Book Description
Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
