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Author : Canadian Government Publishing
Publisher : Unknown
Page : 143 pages
File Size : 45,6 Mb
Release : 1991
Category : Electronic
ISBN : 0660573164
Author : Anonim
Publisher : Unknown
Page : 156 pages
File Size : 52,5 Mb
Release : 1991
Category : Medical instruments and apparatus
ISBN : MINN:31951D00873229I
With 1991: contains domestic, foreign, and international standards for medical devices. Intended for those involved in standards development or interested in specifying safety and performance.
Author : Michael Cheng,World Health Organization
Publisher : World Health Organization
Page : 54 pages
File Size : 45,9 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 : Amiram Daniel,Ed Kimmelman
Publisher : Quality Press
Page : 344 pages
File Size : 43,6 Mb
Release : 2008-02-21
Category : Medical
ISBN : 9780873892049
This new and expanded second edition maintains the organizational approach of the first and includes the requirements and guidance contained in the Quality System Regulation (QSReg), the ISO 13485:2003 standard, the ISO/TR 14969:2004 guidance document, and, as appropriate, a number of the FDA and Global Harmonization Task Force (GHTF) guidance documents.This second edition also addresses a number of additional topics, such as the incorporation of risk management into the medical device organization’s QMS, QMS issues related to combination products, the key process interactions within a QMS, effective presentation of and advocacy for a QMS during FDA inspections and third-party assessments, and future FDA compliance and standards activities. The organization of the guidebook is based on the order of the requirements in the QSReg. For each substantive requirement section there is: A verbatim statement of the QSReg requirement. A description of the comparable requirement in ISO 13485:2003, focusing on any additions to or differences from the requirements contained in the QSReg.Excerpts of the FDA responses to relevant comment groups contained in the Preamble to the QSReg. Excerpts from various FDA guidance documents related to quality management systems. A description of the relevant guidance contained in ISO/TR 14969:2004, focusing on any additions to or differences from the guidance in the Preamble and other FDA guidance documents, and, if useful, excerpts from relevant GHTF guidances. Authors’ notes giving guidance derived from the authors’ sixty years of regulatory compliance experience. This guidance book is meant as a resource to manufacturers of medical devices, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS.
Author : Institute of Medicine,Council on Health Care Technology
Publisher : National Academies Press
Page : 709 pages
File Size : 52,7 Mb
Release : 1988-02-01
Category : Medical
ISBN : 9780309038294
For the first time, a single reference identifies medical technology assessment programs. A valuable guide to the field, this directory contains more than 60 profiles of programs that conduct and report on medical technology assessments. Each profile includes a listing of report citations for that program, and all the reports are indexed under major subject headings. Also included is a cross-listing of technology assessment report citations arranged by type of technology headings, brief descriptions of approximately 70 information sources of potential interest to technology assessors, and addresses and descriptions of 70 organizations with memberships, activities, publications, and other functions relevant to the medical technology assessment community.
Author : Anonim
Publisher : Unknown
Page : 856 pages
File Size : 51,9 Mb
Release : 1995-02
Category : Government publications
ISBN : UIUC:30112018364353
Author : https://www.codeofchina.com
Publisher : https://www.codeofchina.com
Page : 265 pages
File Size : 52,5 Mb
Release : 2024-07-01
Category : Architecture
ISBN : 8210379456XXX
HTTPS://WWW.CODEOFCHINA.COM EMAIL:[email protected] "Codeofchina Inc., a part of TransForyou (Beijing) Translation Co., Ltd., is a professional Chinese code translator in China. Now, Codeofchina Inc. is running a professional Chinese code website, www.codeofchina.com. Through this website, Codeofchina Inc. provides English-translated Chinese codes to clients worldwide. About TransForyou TransForyou (Beijing) Translation Co., Ltd., established in 2003, is a reliable language service provider for clients at home and abroad. Since our establishment, TransForyou has been aiming to build up a translation brand with our professional dedicated service. Currently, TransForyou is the director of China Association of Engineering Construction Standardization (CECS); the committeeman of Localization Service Committee / Translators Association of China (TAC) and the member of Boya Translation Culture Salon (BTCS); and the field study center of the University of the University of International Business & Economics (UIBE) and Hebei University (HU). In 2016, TransForyou ranked 27th among Asian Language Service Providers by Common Sense Advisory. "
Author : Shayne C. Gad
Publisher : Springer Nature
Page : 490 pages
File Size : 41,6 Mb
Release : 2020-02-24
Category : Medical
ISBN : 9783030352417
While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation. Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex. A part of this, requirements for ensuring safety (once based on use of previously acceptable materials – largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant (yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understand, and solve all of them. • Identify and verify the most appropriate available data. • As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest. • As the duration (and rate) of exposure to moieties released from a device are most frequently different (longer) than what available data speaks to, transformation across tissue is required. • As innate and adaptive immune responses are a central part of device/patient interaction, assessing potential risks on this basis are required. • Incorporating assessments for special populations such as neonates. • Use of (Q)SAR (Quantitative Structure Activity Relationships) modeling in assessments. • Performance and presentation of integrative assessments covering all potential biologic risks. Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devices.
Author : Anonim
Publisher : Unknown
Page : 778 pages
File Size : 50,5 Mb
Release : 1993
Category : Administrative agencies
ISBN : UOM:39015028198409
Author : Anonim
Publisher : DIANE Publishing
Page : 727 pages
File Size : 40,5 Mb
Release : 1994
Category : Electronic
ISBN : 9780788101915
Describes the individual capabilities of each of 1,900 unique resources in the federal laboratory system, and provides the name and phone number of each contact. Includes government laboratories, research centers, testing facilities, and special technology information centers. Also includes a list of all federal laboratory technology transfer offices. Organized into 72 subject areas. Detailed indices.
Author : Shayne C. Gad,Marian G. McCord
Publisher : CRC Press
Page : 314 pages
File Size : 50,5 Mb
Release : 2008-10-20
Category : Medical
ISBN : 9781439809488
Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-l
Author : World Health Organization
Publisher : World Health Organization
Page : 608 pages
File Size : 40,9 Mb
Release : 2022-11-24
Category : Medical
ISBN : 9789240062207
Author : Anonim
Publisher : Unknown
Page : 458 pages
File Size : 47,5 Mb
Release : 1985
Category : Government publications
ISBN : PURD:32754073297099
Author : Anonim
Publisher : Unknown
Page : 426 pages
File Size : 53,5 Mb
Release : 2014
Category : Delegated legislation
ISBN : UCR:31210024752576
Author : United States. Superintendent of Documents
Publisher : Unknown
Page : 2556 pages
File Size : 50,7 Mb
Release : 2024-07-01
Category : Government publications
ISBN : IND:30000133147938