The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices PDF

Author: Amiram Daniel

Publisher: Quality Press

Published: 2008-01-01

Total Pages: 355

ISBN-13: 0873897404

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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.

FDA Quality System Regulation for Medical Devices (21 CFR Part 820)

FDA Quality System Regulation for Medical Devices (21 CFR Part 820) PDF

Author: D. G. Daugherty

Publisher: Createspace Independent Publishing Platform

Published: 2015-12-19

Total Pages: 58

ISBN-13: 9781522840244

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The Practitioner's Guide to Management Controls was written to provide a simple, single source of information for United States Food and Drug Administration's (FDA) requirements for Management Controls as described in 21 CFR Part 820 Quality System Regulation (QS Regulation) for Medical Devices. Management Controls include sections 820.20 Management Responsibility, 820.22 Quality Audit, and 820.25 Personnel of this medical device regulation. The Practitioner's Guide to Management Controls is written for the practitioner to use as a tool to help develop management controls prospectively for a new quality system or to perform gap assessments between existing management controls in a quality system against the FDA requirements and expectations provided in this book.

Medical Devices and the Public's Health

Medical Devices and the Public's Health PDF

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2011-10-25

Total Pages: 318

ISBN-13: 0309212456

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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.

Medical Device Regulations

Medical Device Regulations PDF

Author: Michael Cheng

Publisher: World Health Organization

Published: 2003-09-16

Total Pages: 54

ISBN-13: 9241546182

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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.

Sensor Technologies

Sensor Technologies PDF

Author: Michael J. McGrath

Publisher: Apress

Published: 2014-01-23

Total Pages: 321

ISBN-13: 1430260149

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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

The FDA and Worldwide Quality System Requirements Guide Book for Medical Devices

The FDA and Worldwide Quality System Requirements Guide Book for Medical Devices PDF

Author: Kimberly A. Trautman

Publisher: ASQ Quality Press

Published: 1997

Total Pages: 224

ISBN-13:

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This book provides essential information regarding the new FDA regulation for medical devices and international quality system requirements (ISO 9001 and ISO/DIS 13485:1996). Icons quickly establish the differences and relationship between FDA regulation, the ISO 9001 standard, FDA guidance, and the Global Harmonization Task Force (GHTF) guidance. In addition, the end of each subsection includes blank pages for your notes. This book allows manufacturers to establish a single quality system that satisfies world requirements.

Scar Management - ECAB

Scar Management - ECAB PDF

Author: Niti Khunger

Publisher: Elsevier Health Sciences

Published: 2013-07-12

Total Pages: 136

ISBN-13: 8131231712

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A number of scar revision techniques can be utilized to treat specific types of scars, in combination with each other or with adjunctive therapies to achieve optimal results. Pathological conditions like hypertrophic scars and keloids are still challenging. Though a number of therapies exist to treat keloids, such as intralesional steroids and anti-metabolites, cryosurgery, to name a few, none are definitive in treatment. Understanding the molecular basis of keloids may lead to development of new therapies. Striae, also known as ‘stretch marks’, are extremely common, disfiguring and a real challenge to treat. Management of striae is a neglected field of research. Except for topical retinoids, the efficacy satisfactorily. Current treatment options include chemical peels, lasers and collagen induction therapy, with a tendency towards active intervention. However, studies are necessary to determine treatment strategies which produce results that are effective with minimal adverse effects. Post-acne scarring is one of the most common causes of facial scars, causing considerable cosmetic disability. Acne is a common skin disorder, unfortunately affecting a large number of teenagers. Usually patients have a combination of different types of scars; hence no single modality is useful. A combination of procedures is generally required for a satisfactory cosmetic outcome. The use of fractional lasers is gaining importance, as it is a minimally invasive procedure as compared to aggressive resurfacing procedures of the past. Collagen induction therapy is another promising technique. Today, patients are also getting up-to-date information about the various modalities available for scar treatment through media, such as magazines, advertisements and internet. However, exaggerated advertisements and information from nonprofessional sources, particularly with regard to lasers can influence patient expectations and result in unrealistic expectations. Patients need to understand that deep scars cannot be eliminated fully and can only be improved. They usually have high expectations from procedural techniques. Proper counseling is extremely important for a happy and satisfactory outcome. Current innovations and techniques in scar prevention and management and increasing use of minimally invasive surgeries are paving the way toward smoother, less noticeable scars. Every surgeon practicing aesthetics should be well versed with modalities of scar management and this is the aim of this clinical update.

The Role of Human Factors in Home Health Care

The Role of Human Factors in Home Health Care PDF

Author: National Research Council

Publisher: National Academies Press

Published: 2010-11-14

Total Pages: 322

ISBN-13: 0309156297

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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.

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